1
00:00:06,268 --> 00:00:06,935
I WILL OPEN THE MEETING I AM THE

2
00:00:06,935 --> 00:00:13,275
PROGRAM OFFICER HERE AT

3
00:00:13,275 --> 00:00:18,546
FOCUSED ON THE MICRO BIOME AND I

4
00:00:18,546 --> 00:00:26,021
ALSO SERVE AS THE INSTITUTE

5
00:00:26,021 --> 00:00:26,655
POINT OF CONTACT FOR MICRO BIOME

6
00:00:26,655 --> 00:00:27,188
RESEARCH WHICH IS 1 OF THE

7
00:00:27,188 --> 00:00:27,956
REASONS WHY I WILL BE MODERATING

8
00:00:27,956 --> 00:00:35,397
TODAY'S MEETING.

9
00:00:35,397 --> 00:00:45,874
HAVE A FEW SLIDES THERE ARE

10
00:00:55,717 --> 00:01:04,392
MEMBERS IN THE AUDIENCE.

11
00:01:04,392 --> 00:01:14,903
AND NICKY IS THE THAN FROM THE

12
00:01:16,338 --> 00:01:26,748
CENTER FOR DISEASE CONTROL.

13
00:01:41,029 --> 00:01:41,563
>> SO THIS IS HOW THE
MEETING

14
00:01:41,563 --> 00:01:41,863
WILL BE RUN.

15
00:01:41,863 --> 00:01:42,497
I AM A MODERATOR TODAY I WILL BE

16
00:01:42,497 --> 00:01:42,831
KEEPING TIME.

17
00:01:42,831 --> 00:01:46,868
I'M NOT VERY IMPOSING BUT I WILL

18
00:01:46,868 --> 00:01:47,435
STAND UP WHEN YOU ARE OUT OF

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00:01:47,435 --> 00:01:47,635
TIME.

20
00:01:47,635 --> 00:01:48,203
WILL TRY TO KEEP EVERYTHING

21
00:01:48,203 --> 00:01:48,703
PRETTY TIGHT TODAY.

22
00:01:48,703 --> 00:01:52,907
DEPENDING ON THE SESSION 10 OR

23
00:01:52,907 --> 00:01:55,610
15 MINUTES FOR Q&A OBVIOUSLY
IN

24
00:01:55,610 --> 00:02:06,154
PERSON QUESTIONS SO THE VIRTUAL

25
00:02:12,927 --> 00:02:23,238
ATTENDEES ARE JOINING BY ZOOM.

26
00:02:23,238 --> 00:02:23,872
AND THEN THE Q&A COMES TO
THE

27
00:02:23,872 --> 00:02:24,139
CHAT BOX.

28
00:02:24,139 --> 00:02:24,739
IN THE VIDEOCAST IS LIVE RIGHT

29
00:02:24,739 --> 00:02:34,149
NOW AND WILL ALSO BE ARCHIVED.

30
00:02:34,149 --> 00:02:35,583
SO THIS IS JUST LOGISTICS WITH

31
00:02:35,583 --> 00:02:45,894
VIRTUAL ATTENDEES.

32
00:02:51,366 --> 00:02:51,833
AND IF YOU ARE LOOKING TO

33
00:02:51,833 --> 00:02:52,400
PRESENT THERE IS A POINT OF

34
00:02:52,400 --> 00:02:53,001
CONTACT FOR YOUR PRESENTATION

35
00:02:53,001 --> 00:02:58,039
FILES.

36
00:02:58,039 --> 00:03:03,645
THIS IS THE MOST IMPORTANT SLIDE

37
00:03:03,645 --> 00:03:04,245
IN ALL SERIOUSNESS WE HAVE NO

38
00:03:04,245 --> 00:03:04,579
FOOD ON-SITE.

39
00:03:04,579 --> 00:03:08,583
WE HAVE ORGANIZED A MENU.

40
00:03:08,583 --> 00:03:14,689
IT IS IMPORTANT THIS IS THE ONLY

41
00:03:14,689 --> 00:03:17,125
SOURCE OF FOOD.

42
00:03:17,125 --> 00:03:18,793
IF YOU DON'T FIND ANYTHING YOU

43
00:03:18,793 --> 00:03:21,429
WOULD LIKE HERE THERE ARE OTHER

44
00:03:21,429 --> 00:03:24,065
OPTIONS.

45
00:03:24,065 --> 00:03:25,633
JUST COMMON ASK ME WE HAVE 1

46
00:03:25,633 --> 00:03:29,571
HOUR 15 MINUTES FOR LUNCH.

47
00:03:29,571 --> 00:03:30,672
SO WE JUST NEED TO USE THE QR

48
00:03:30,672 --> 00:03:35,243
CODE.

49
00:03:35,243 --> 00:03:40,181
MAKE SURE THAT YOU PURCHASE AND

50
00:03:40,181 --> 00:03:40,815
IF YOU DON'T GET THAT E-MAIL THE

51
00:03:40,815 --> 00:03:49,757
SEASON YOU DID NOT DO IT RIGHT.

52
00:03:49,757 --> 00:03:50,391
OTHERWISE YOUR LUNCH WILL NOT BE

53
00:03:50,391 --> 00:03:51,025
THERE BUT THEY WILL BE DELIVERED

54
00:03:51,025 --> 00:03:51,626
AT 1145 THROUGH THE DOORS AND

55
00:03:51,626 --> 00:03:59,868
INTO THE CAFETERIA.

56
00:03:59,868 --> 00:04:10,345
MY ROLE HERE AS A MODERATOR.

57
00:04:11,746 --> 00:04:12,280
SO THE PRESENTATION WILL BE BY

58
00:04:12,280 --> 00:04:12,914
DOCTOR DAVID KASLOW A MEMBER OF

59
00:04:12,914 --> 00:04:15,850
THE ORGANIZING COMMITTEE.

60
00:04:15,850 --> 00:04:20,889
A RELATIVELY RECENTLY MINTED

61
00:04:20,889 --> 00:04:23,491
DIRECTOR AT THE CENTER FOR

62
00:04:23,491 --> 00:04:25,827
BIOLOGICS EVALUATION AND

63
00:04:25,827 --> 00:04:32,066
RESEARCH AND WILL TALK TO US

64
00:04:32,066 --> 00:04:34,502
ABOUT LIVE FILE THERAPEUTIC

65
00:04:34,502 --> 00:04:35,169
PRODUCTS.

66
00:04:35,169 --> 00:04:40,475
>> ON BEHALF OF US FDA LET
ME

67
00:04:40,475 --> 00:04:41,976
GIVE ME WELCOME TO THE WORKSHOP

68
00:04:41,976 --> 00:04:44,546
SPEAKERS HERE ON PERSON AND

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00:04:44,546 --> 00:04:47,482
ONLINE ALSO THANK YOU TO

70
00:04:47,482 --> 00:04:52,687
COLLEAGUES FROM CDC AND NIH.

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00:04:52,687 --> 00:04:53,621
I WILL START BY SAYING ALL OF MY

72
00:04:53,621 --> 00:04:56,124
COMMENTS TODAY COME WITH THE

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00:04:56,124 --> 00:04:58,660
EXPLICIT DISCLAIMER THAT THEY

74
00:04:58,660 --> 00:05:02,263
NEITHER BIND NOR OBLIGATE THE

75
00:05:02,263 --> 00:05:03,264
FDA WITH NO COMPLEX OF

76
00:05:03,264 --> 00:05:07,669
DISCLOSURES.

77
00:05:07,669 --> 00:05:08,303
SO MY ASSIGNMENT IN THE NEXT 20

78
00:05:08,303 --> 00:05:08,903
MINUTES OR LESS IS TO SET THE

79
00:05:08,903 --> 00:05:11,706
STAGE FOR TODAY'S MEETING FROM A

80
00:05:11,706 --> 00:05:18,346
REGULATORY PERSPECTIVE.

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00:05:18,346 --> 00:05:19,647
I WOULD JUST LIKE TO QUICKLY

82
00:05:19,647 --> 00:05:30,124
WALK THROUGH TODAY'S AGENDA.

83
00:05:41,803 --> 00:05:42,303
AND WE ARE TRYING TO SET THE

84
00:05:42,303 --> 00:05:42,904
STAGE FOR THE WORKSHOP THROUGH

85
00:05:42,904 --> 00:05:43,538
EPIDEMIOLOGY AND THE NUTRITIONAL

86
00:05:43,538 --> 00:05:44,105
ASPECTS OF LOW BIRTH WEIGHT

87
00:05:44,105 --> 00:05:44,339
INFANTS.

88
00:05:44,339 --> 00:05:47,809
THAT IS FOLLOWED BY A 2 TALKS

89
00:05:47,809 --> 00:05:49,310
CRITICAL FOR CLINICAL

90
00:05:49,310 --> 00:05:53,514
INVESTIGATION THAT IS THE NET

91
00:05:53,514 --> 00:05:55,817
CASE DEFINITION OF POTENTIAL

92
00:05:55,817 --> 00:05:57,352
SAFETY SIGNALS OF SPECIAL

93
00:05:57,352 --> 00:05:59,220
INTEREST.

94
00:05:59,220 --> 00:06:03,091
AFTER Q&A WE WILL OPEN
PUBLIC

95
00:06:03,091 --> 00:06:11,299
COMMENT SESSION WITH 3 REQUESTED

96
00:06:11,299 --> 00:06:11,866
PRESENTATIONS AFTER LUNCH WE

97
00:06:11,866 --> 00:06:12,433
WILL HAVE 2 SESSIONS AND THE

98
00:06:12,433 --> 00:06:16,404
FIRST IS A DEEPER DIVE INTO THE

99
00:06:16,404 --> 00:06:23,211
CLINICAL TRIAL DESIGN WITH NEC

100
00:06:23,211 --> 00:06:23,778
AND THEN WE'LL FOCUS ON THE

101
00:06:23,778 --> 00:06:33,454
CHALLENGES AND OPPORTUNITIES.

102
00:06:33,454 --> 00:06:36,591
AND WITH THE REGULATORY OVERVIEW

103
00:06:36,591 --> 00:06:43,264
WITH A COMMONLY USED TERMS.

104
00:06:43,264 --> 00:06:44,732
AND WITH A LIVE BIO THERAPEUTIC

105
00:06:44,732 --> 00:06:54,809
PRODUCT.

106
00:06:54,809 --> 00:06:55,843
AND THESE CONTAIN ORGANISMS SUCH

107
00:06:55,843 --> 00:07:00,982
AS BACTERIA.

108
00:07:00,982 --> 00:07:01,482
WITH THE PREVENTION AND

109
00:07:01,482 --> 00:07:03,584
TREATMENT OR CONDITION OF HUMAN

110
00:07:03,584 --> 00:07:12,593
BEINGS AND IS NOT A VACCINE.

111
00:07:12,593 --> 00:07:13,227
I WILL HIGHLIGHT 3 COMMONLY USED

112
00:07:13,227 --> 00:07:13,828
TERMS YOU WILL HEAR THROUGHOUT

113
00:07:13,828 --> 00:07:18,232
THE COURSE OF THE DAY FIRST IS

114
00:07:18,232 --> 00:07:18,866
BIOLOGICAL PRODUCTS ALSO KNOWN

115
00:07:18,866 --> 00:07:19,200
AS BIOLOGICS.

116
00:07:19,200 --> 00:07:23,905
THESE ARE REGULATED BY FDA AND

117
00:07:23,905 --> 00:07:24,172
IS USED TO

118
00:07:24,172 --> 00:07:26,507
DIAGNOSE, PREVENT, TREAT OR CURE

119
00:07:26,507 --> 00:07:31,913
DISEASES AND MEDICAL

120
00:07:31,913 --> 00:07:32,213
CONDITIONS.

121
00:07:32,213 --> 00:07:32,780
IT IS A DIVERSE CATEGORY OF

122
00:07:32,780 --> 00:07:33,347
PRODUCTS OF GENERALLY LARGE

123
00:07:33,347 --> 00:07:33,915
COMPLEX MOLECULES INCLUDING

124
00:07:33,915 --> 00:07:35,149
MICROORGANISMS.

125
00:07:35,149 --> 00:07:38,386
PROBIOTICS ARE NOT DEFINED AS A

126
00:07:38,386 --> 00:07:45,560
REGULATORY PRODUCT CATEGORY.

127
00:07:45,560 --> 00:07:47,228
THAT WOULD BE FOOD DRUGS AND

128
00:07:47,228 --> 00:07:50,932
BIOLOGICS DEPENDING ON THE

129
00:07:50,932 --> 00:07:59,273
INTENDED USE OF THAT PRODUCT AND

130
00:07:59,273 --> 00:08:00,141
DESPITE HOUSES IS A TERM PRONE

131
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TO MISINTERPRETATION AND MISUSE

132
00:08:07,415 --> 00:08:08,116
IS PRONE TO MISINTERPRETATION

133
00:08:08,116 --> 00:08:11,552
AND WE AVOID THAT TURN AND TO A

134
00:08:11,552 --> 00:08:14,555
SITUATION TERMINOLOGY THAT IS

135
00:08:14,555 --> 00:08:18,593
MEANT TO ACTUALLY HIGHLIGHT THE

136
00:08:18,593 --> 00:08:19,227
FUNCTION OF THE MICRO BIOME SUCH

137
00:08:19,227 --> 00:08:23,464
AS DYSFUNCTIONAL OR DISEASE

138
00:08:23,464 --> 00:08:32,106
PROMOTING.

139
00:08:32,106 --> 00:08:36,177
NEXT I WOULD LIKE TO START WITH

140
00:08:36,177 --> 00:08:36,811
THE PROPOSED AND CERTAINLY OPEN

141
00:08:36,811 --> 00:08:37,378
FOR DISCUSSION, A STRATEGIC

142
00:08:37,378 --> 00:08:46,888
INTENT STATEMENT.

143
00:08:46,888 --> 00:08:47,455
AND THAT IS THE INTENT IS TO

144
00:08:47,455 --> 00:08:48,055
DISCUSS A WELL-DEFINED PATHWAY

145
00:08:48,055 --> 00:08:48,656
TO DEMONSTRATE THE EVIDENCE OF

146
00:08:48,656 --> 00:08:51,692
SLEEP THE INEFFECTIVENESS AND

147
00:08:51,692 --> 00:08:52,260
QUALITY OF LIFE THERAPEUTIC

148
00:08:52,260 --> 00:08:52,827
PRODUCTS ARE VERY LOW BIRTH

149
00:08:52,827 --> 00:08:58,099
WEIGHT INFANTS TO PREVENT NEC

150
00:08:58,099 --> 00:09:05,239
THAT MEET STATUTORY STANDARDS.

151
00:09:05,239 --> 00:09:05,840
BUT I WOULD ALSO LIKE TO DO IS

152
00:09:05,840 --> 00:09:07,775
WITHIN THE STRATEGIC AND A

153
00:09:07,775 --> 00:09:15,917
STRATEGIC INTENT IS A PROPOSED

154
00:09:15,917 --> 00:09:16,551
PROBLEM STATEMENT IS A VERY LOW

155
00:09:16,551 --> 00:09:17,185
BIRTH WEIGHT INFANTS AND REMAINS

156
00:09:17,185 --> 00:09:18,519
A SIGNIFICANT PUBLIC HEALTH

157
00:09:18,519 --> 00:09:19,253
PROBLEM.

158
00:09:19,253 --> 00:09:25,226
FDA HAS NOT APPROVED ANY

159
00:09:25,226 --> 00:09:27,628
PRODUCTS FOR NEC VARIOUS

160
00:09:27,628 --> 00:09:29,664
PRODUCTS MARKETED AS PROBIOTICS

161
00:09:29,664 --> 00:09:30,731
HAVE BEEN USED IN EFFORTS TO

162
00:09:30,731 --> 00:09:34,235
PREVENT THIS SERIOUS AND

163
00:09:34,235 --> 00:09:34,869
LIFE-THREATENING DISEASE HOWEVER

164
00:09:34,869 --> 00:09:36,637
THESE PRODUCTS HAVE NOT BEEN

165
00:09:36,637 --> 00:09:39,340
MADE USING PHARMACEUTICAL GOOD

166
00:09:39,340 --> 00:09:43,911
MANUFACTURING PRACTICES.

167
00:09:43,911 --> 00:09:44,412
SUBSTANTIAL EVIDENCE OF

168
00:09:44,412 --> 00:09:45,446
EFFECTIVENESS HAS NOT YET BEEN

169
00:09:45,446 --> 00:09:47,348
DEMONSTRATED WITH SERIOUS

170
00:09:47,348 --> 00:09:51,586
ADVERSE OUTCOMES INCLUDING DEATH

171
00:09:51,586 --> 00:09:52,220
HAVE BEEN REPORTED FOLLOWING THE

172
00:09:52,220 --> 00:10:02,597
USE OF THESE PRODUCTS.

173
00:10:02,797 --> 00:10:03,297
I WAS NEXT LIKE TO TURN SOME

174
00:10:03,297 --> 00:10:04,265
TOPICS IN KEY UNDERLYING

175
00:10:04,265 --> 00:10:07,235
ASSUMPTIONS TO GAIN SOME

176
00:10:07,235 --> 00:10:08,569
ALIGNMENT DURING THE COURSE OF

177
00:10:08,569 --> 00:10:10,738
TODAY'S WORKSHOP.

178
00:10:10,738 --> 00:10:15,076
AND THAT IS TO ALIGN ON THE

179
00:10:15,076 --> 00:10:19,280
BIOLOGICAL PRODUCT THAT CONTINUE

180
00:10:19,280 --> 00:10:19,914
MICROORGANISMS SUCH AS BACTERIA

181
00:10:19,914 --> 00:10:23,851
WITH THE INTENDED USE TO PREVENT

182
00:10:23,851 --> 00:10:27,488
A SURE A VERY LOW BIRTH WEIGHT

183
00:10:27,488 --> 00:10:29,023
INFANTS OR REGULATED AS

184
00:10:29,023 --> 00:10:32,460
BIOLOGICS AND THEN TO PRESSURE

185
00:10:32,460 --> 00:10:33,494
TEST 2 KEY UNDERLYING

186
00:10:33,494 --> 00:10:36,330
ASSUMPTIONS THAT ADEQUATE AND

187
00:10:36,330 --> 00:10:37,565
WELL-CONTROLLED CLINICAL

188
00:10:37,565 --> 00:10:39,367
INVESTIGATIONS TO ESTABLISH

189
00:10:39,367 --> 00:10:44,505
SAFETY AND EFFECTIVENESS IN THE

190
00:10:44,505 --> 00:10:45,139
VERY LOW BIRTH WEIGHT INFANTS TO

191
00:10:45,139 --> 00:10:47,375
MAKE THE STATUTORY REQUIREMENTS

192
00:10:47,375 --> 00:10:53,214
FOR ETHICAL AND FEASIBLE.

193
00:10:53,214 --> 00:10:53,681
AND SECOND LBP CAN BE

194
00:10:53,681 --> 00:10:56,450
MANUFACTURED CONSISTENTLY AND IN

195
00:10:56,450 --> 00:10:59,287
COMPLIANCE WITH GOOD

196
00:10:59,287 --> 00:11:00,554
MANUFACTURING PRACTICE

197
00:11:00,554 --> 00:11:10,765
REGULATIONS.

198
00:11:11,999 --> 00:11:12,533
WITH THAT INTRODUCTION NEXT I

199
00:11:12,533 --> 00:11:14,535
WOULD LIKE TO PROPOSED THE PICO

200
00:11:14,535 --> 00:11:22,510
QUESTION BUT THE FOCUS OF THE

201
00:11:22,510 --> 00:11:23,444
WORKSHOP OBVIOUSLY THIS IS OPEN

202
00:11:23,444 --> 00:11:29,917
FOR DISCUSSION IS IT IS MEANT TO

203
00:11:29,917 --> 00:11:36,724
IDENTIFY THE TARGETED GROUP THE

204
00:11:36,724 --> 00:11:37,224
CONTROL INTERVENTION AND

205
00:11:37,224 --> 00:11:38,192
INTERVENTIONS EXPECTED RESULTS

206
00:11:38,192 --> 00:11:40,094
AND TO GET US STARTED.

207
00:11:40,094 --> 00:11:50,538
OPEN FOR DISCUSSION AND TO

208
00:11:52,073 --> 00:11:54,208
PROPOSE THE FOCUS OF THIS

209
00:11:54,208 --> 00:12:00,047
WORKSHOP AND IN THAT WE FOCUS ON

210
00:12:00,047 --> 00:12:10,558
THE BIO THERAPEUTIC PRODUCTS.

211
00:12:23,537 --> 00:12:24,138
SO TO TURN THE ATTENTION TO THE

212
00:12:24,138 --> 00:12:26,073
REGULATORY PATHWAYS THAT ARE

213
00:12:26,073 --> 00:12:29,877
AVAILABLE IT IS IMPORTANT TO

214
00:12:29,877 --> 00:12:30,711
EMPHASIZE THAT THERE IS THE

215
00:12:30,711 --> 00:12:36,784
EXISTING LEGAL FRAMEWORK WE MUST

216
00:12:36,784 --> 00:12:37,685
OPERATE AND THAT STARTS WITH

217
00:12:37,685 --> 00:12:39,253
LAWS AND STATUTES THAT ARE

218
00:12:39,253 --> 00:12:41,856
TRANSLATED INTO REGULATIONS

219
00:12:41,856 --> 00:12:43,891
PARTICULARLY THE CLOSE AND THOSE

220
00:12:43,891 --> 00:12:48,129
ARE TRANSLATED INTO GUIDANCE AND

221
00:12:48,129 --> 00:12:56,470
GUIDANCE DOCUMENTS.

222
00:12:56,470 --> 00:12:57,071
SO WITH THAT FRAMEWORK IN MIND

223
00:12:57,071 --> 00:12:57,705
FOR BIOLOGIC PRODUCTS, THERE ARE

224
00:12:57,705 --> 00:13:04,245
6 ACCESS AVENUES.

225
00:13:04,245 --> 00:13:04,879
THROUGH THE LICENSE APPLICATIONS

226
00:13:04,879 --> 00:13:05,346
AND THE EMERGENCY USE

227
00:13:05,346 --> 00:13:08,115
AUTHORIZATION AND ALSO THROUGH

228
00:13:08,115 --> 00:13:09,550
INVESTIGATIONAL NEW DRUG

229
00:13:09,550 --> 00:13:13,020
COMPLICATIONS.

230
00:13:13,020 --> 00:13:14,588
OF THOSE 6 AND FOR TODAY'S

231
00:13:14,588 --> 00:13:25,099
DISCUSSION ON LBP I SUGGEST WE

232
00:13:25,366 --> 00:13:25,833
FOCUS ON 4 OF THESE ACCESS

233
00:13:25,833 --> 00:13:26,367
AVENUES THAT ARE RELEVANT.

234
00:13:26,367 --> 00:13:26,934
THE 2 ON THE TOP OR THROUGH

235
00:13:26,934 --> 00:13:30,871
APPROVED PRODUCTS TRADITIONAL

236
00:13:30,871 --> 00:13:31,439
AND ACCELERATED APPROVAL AND

237
00:13:31,439 --> 00:13:33,240
THEN THE 2 INVESTIGATIONAL

238
00:13:33,240 --> 00:13:36,110
ACCESS AVENUES EXPANDED AND

239
00:13:36,110 --> 00:13:36,844
INVESTIGATIONAL NEW DRUG

240
00:13:36,844 --> 00:13:39,380
APPLICATION.

241
00:13:39,380 --> 00:13:41,715
I HIGHLIGHTED ON THE RIGHT-HAND

242
00:13:41,715 --> 00:13:45,386
SIDE WHAT NEEDS TO BE

243
00:13:45,386 --> 00:13:48,489
ESTABLISHED IN TERMS OF

244
00:13:48,489 --> 00:13:53,761
SUBSTANTIAL EVIDENCE IT IS

245
00:13:53,761 --> 00:13:54,295
THROUGH DIRECT MEASURES OF

246
00:13:54,295 --> 00:13:57,398
CLINICAL BENEFIT OR VALIDATED

247
00:13:57,398 --> 00:14:02,303
WELL-ESTABLISHED AND POINTS THAT

248
00:14:02,303 --> 00:14:02,837
PREDICT CLINICAL BENEFIT.

249
00:14:02,837 --> 00:14:04,839
TALKING ABOUT ACCELERATED

250
00:14:04,839 --> 00:14:07,608
APPROVAL, THIS IS A SURROGATE OR

251
00:14:07,608 --> 00:14:14,582
INTERMEDIATE CLINICAL AND POINT

252
00:14:14,582 --> 00:14:15,116
THAT WILL PREDICT CLINICAL

253
00:14:15,116 --> 00:14:15,749
BENEFIT AND I WANT TO DRAW YOUR

254
00:14:15,749 --> 00:14:19,920
ATTENTION TO THE EXPANDED ACCESS

255
00:14:19,920 --> 00:14:20,554
PATHWAY IN THE REQUIREMENTS AND

256
00:14:20,554 --> 00:14:21,188
RECORD -- -- CRITERIA THAT WILL

257
00:14:21,188 --> 00:14:23,991
BE MET IN ORDER TO ACCESS THAT

258
00:14:23,991 --> 00:14:34,135
PATHWAY.

259
00:14:37,471 --> 00:14:38,038
SO BASED ON THE PROPOSED PICO

260
00:14:38,038 --> 00:14:40,040
QUESTION VERY LOW BIRTH WEIGHT

261
00:14:40,040 --> 00:14:47,014
INFANTS THE INTERVENTION FROM

262
00:14:47,014 --> 00:14:47,615
LIVE BIO THERAPEUTIC PRODUCTS

263
00:14:47,615 --> 00:14:48,115
WITH INTENDED OUTCOME OF

264
00:14:48,115 --> 00:14:55,156
REDUCTION OF INCIDENTS OF

265
00:14:55,156 --> 00:14:56,123
NEC, BASED ON THAT, THAT PRODUCT

266
00:14:56,123 --> 00:14:57,691
WOULD FALL UNDER A BIOLOGICAL

267
00:14:57,691 --> 00:15:02,396
LICENSE WITH REGULATIONS AND

268
00:15:02,396 --> 00:15:06,901
JUST TO BE CLEAR WHAT THAT

269
00:15:06,901 --> 00:15:08,903
REQUIRES IS DEMONSTRATION OF A

270
00:15:08,903 --> 00:15:12,740
PRODUCT SAFETY PURITY AND

271
00:15:12,740 --> 00:15:16,010
POTENCY THAT IS MEANT TO BE

272
00:15:16,010 --> 00:15:19,413
EFFECTIVENESS.

273
00:15:19,413 --> 00:15:20,014
IT ALSO REQUIRES THE FACILITY

274
00:15:20,014 --> 00:15:23,184
NEEDS TO ASSURE NOT JUST

275
00:15:23,184 --> 00:15:26,120
LICENSURE BUT THE PRODUCT

276
00:15:26,120 --> 00:15:32,493
CONTINUES TO BE SAFE AND PURE

277
00:15:32,493 --> 00:15:32,993
AND ONLY THOSE THAT ARE

278
00:15:32,993 --> 00:15:34,862
DEMONSTRATED TO BE SAFE AND

279
00:15:34,862 --> 00:15:37,331
EFFECTIVE AND CAN BE

280
00:15:37,331 --> 00:15:37,898
MANUFACTURED IN A CONSISTENT

281
00:15:37,898 --> 00:15:41,769
MANNER WILL BE LICENSED BY THE

282
00:15:41,769 --> 00:15:47,775
FDA.

283
00:15:47,775 --> 00:15:50,678
SEVERAL EXPEDITED PROGRAMS ARE

284
00:15:50,678 --> 00:15:54,748
AVAILABLE.

285
00:15:54,748 --> 00:15:56,116
THESE APPLY TO INVESTIGATIONAL

286
00:15:56,116 --> 00:15:59,019
PRODUCTS THAT ADDRESS A SERIOUS

287
00:15:59,019 --> 00:16:03,290
CONDITION TO PROVIDE THE

288
00:16:03,290 --> 00:16:08,062
ADVANTAGE OVER AVAILABLE THERAPY

289
00:16:08,062 --> 00:16:09,730
AND TO ADDRESS THE UNMET MEDICAL

290
00:16:09,730 --> 00:16:18,305
NEED.

291
00:16:18,305 --> 00:16:19,907
AND FOR THE FAST TRACK

292
00:16:19,907 --> 00:16:22,343
BREAKTHROUGH THERAPY AND

293
00:16:22,343 --> 00:16:23,711
PRIORITY REVIEW THE FAST TRACK

294
00:16:23,711 --> 00:16:27,615
BREAKTHROUGH AND THAT PROVIDES

295
00:16:27,615 --> 00:16:30,651
ACTIONS DESIGNED TO EXPEDITE THE

296
00:16:30,651 --> 00:16:32,119
DEVELOPMENT AND THE VIEW OF

297
00:16:32,119 --> 00:16:38,626
THESE PRODUCTS.

298
00:16:38,626 --> 00:16:39,126
IT IS SIGNIFICANTLY MORE

299
00:16:39,126 --> 00:16:39,760
INTENSIVE INTERACTIONS WITH THE

300
00:16:39,760 --> 00:16:49,837
FDA.

301
00:16:53,240 --> 00:16:53,674
AND SOME OF THE FORMAL

302
00:16:53,674 --> 00:16:54,241
MECHANISMS MEETING WITH FDA

303
00:16:54,241 --> 00:16:54,808
THROUGH THE LIFECYCLE OF THE

304
00:16:54,808 --> 00:16:55,042
PRODUCT.

305
00:16:55,042 --> 00:16:57,478
AND EMPHASIZED A SHARED PUBLIC

306
00:16:57,478 --> 00:16:59,747
HEALTH GOAL OF SAFE AND

307
00:16:59,747 --> 00:17:03,851
EFFECTIVE KEYS THROUGH EFFECTIVE

308
00:17:03,851 --> 00:17:04,451
COMMUNICATION WITH SPONSORS AS

309
00:17:04,451 --> 00:17:05,019
SHOWN ON THE BOTTOM OF THE

310
00:17:05,019 --> 00:17:15,129
SLIDE.

311
00:17:16,497 --> 00:17:17,031
I WOULD LIKE TO EMPHASIZE OUR

312
00:17:17,031 --> 00:17:17,564
COMMITMENT TO EXPEDITE THE

313
00:17:17,564 --> 00:17:18,065
REVIEW PROCESS FOR THOSE

314
00:17:18,065 --> 00:17:18,599
PRODUCTS THAT ADDRESS THE

315
00:17:18,599 --> 00:17:19,066
SERIOUS CONDITION AND

316
00:17:19,066 --> 00:17:22,369
DEMONSTRATE THE POTENTIAL TO BE

317
00:17:22,369 --> 00:17:22,936
A SIGNIFICANT IMPROVEMENT OF

318
00:17:22,936 --> 00:17:24,705
SAFETY AND EFFECTIVENESS AND

319
00:17:24,705 --> 00:17:27,007
RATHER THAN THE 12 MONTH REVIEW

320
00:17:27,007 --> 00:17:32,413
TIMELINE YOU SEE AT THE TO

321
00:17:32,413 --> 00:17:33,013
TOP, PRIORITY REVIEW SHORTENS

322
00:17:33,013 --> 00:17:36,583
THE REVIEW TIME BY 1 THIRD BY 4

323
00:17:36,583 --> 00:17:37,851
MONTHS WITH THE INTENSIVE

324
00:17:37,851 --> 00:17:45,626
SIX-MONTH REVIEW.

325
00:17:45,626 --> 00:17:48,362
SO TO BRIEFLY SUMMARIZE

326
00:17:48,362 --> 00:17:54,902
CONSIDERING NEC IN VLBW A

327
00:17:54,902 --> 00:17:55,436
SIGNIFICANT PUBLIC HEALTH

328
00:17:55,436 --> 00:17:58,706
PROBLEM AND GIVING THE PROPOSED

329
00:17:58,706 --> 00:18:00,107
PICO QUESTION THE PRODUCTS WOULD

330
00:18:00,107 --> 00:18:10,651
BE CATEGORIZED AS LBP THERE ARE

331
00:18:10,951 --> 00:18:11,518
SEVERAL PATHWAYS WHAT THOSE THAT

332
00:18:11,518 --> 00:18:12,119
EXIST TO FACILITATE ACCESS TO

333
00:18:12,119 --> 00:18:14,054
LBP AND 1 OF THE GOALS OF

334
00:18:14,054 --> 00:18:18,659
TODAY'S WORKSHOP IS TO DISCUSS

335
00:18:18,659 --> 00:18:20,527
THE KEY UNDERLYING ASSUMPTIONS

336
00:18:20,527 --> 00:18:31,071
TO PREVENT NEC IN VLBW INFANTS.

337
00:18:34,108 --> 00:18:44,585
>> I HOPE THAT SET THE
STAGE SO

338
00:18:45,886 --> 00:18:46,453
THE NEXT SPEAKER, KAREN PUOPOLO

339
00:18:46,453 --> 00:18:46,987
A PROFESSOR OF PEDIATRICS

340
00:18:46,987 --> 00:18:47,521
UNIVERSITY OF PENNSYLVANIA

341
00:18:47,521 --> 00:18:51,191
SCHOOL OF MEDICINE AT THE

342
00:18:51,191 --> 00:18:51,658
CHILDREN'S HOSPITAL OF

343
00:18:51,658 --> 00:18:55,963
PHILADELPHIA.

344
00:18:55,963 --> 00:19:01,702
THAT IS WITH NEC AND VLBW BABIES

345
00:19:01,702 --> 00:19:03,370
IN THE NICU.

346
00:19:03,370 --> 00:19:07,408
>> GOOD MORNING.

347
00:19:07,408 --> 00:19:10,277
I AM STARTING OUT THIS

348
00:19:10,277 --> 00:19:12,179
CONFERENCE AND HOPEFULLY OVER

349
00:19:12,179 --> 00:19:14,648
THE NEXT 25 MINUTES HE WILL SEE

350
00:19:14,648 --> 00:19:17,084
WHAT YOU PROBABLY ALREADY KNOW

351
00:19:17,084 --> 00:19:25,159
THAT NECK IS UNFORTUNATELY

352
00:19:25,159 --> 00:19:25,626
COMMON COMPLICATION OF

353
00:19:25,626 --> 00:19:26,160
PREMATURITY WITH TERRIBLE

354
00:19:26,160 --> 00:19:26,760
SHORT-TERM AND LONG-TERM LIFE

355
00:19:26,760 --> 00:19:37,004
IMPLICATIONS.

356
00:19:39,273 --> 00:19:39,840
I HAVE NO CONFLICTS RELATIVE TO

357
00:19:39,840 --> 00:19:40,407
THE PRESENTATION AND THIS IS

358
00:19:40,407 --> 00:19:44,945
WHAT WE WILL SPEAK ABOUT TODAY

359
00:19:44,945 --> 00:19:45,579
AND THE DEMOGRAPHICS THAT I CAN

360
00:19:45,579 --> 00:19:50,083
DESCRIBE IN THE ASSOCIATIONS AND

361
00:19:50,083 --> 00:19:52,453
THEN WHAT ARE THE CONSEQUENCES

362
00:19:52,453 --> 00:19:53,620
BOTH WITH

363
00:19:53,620 --> 00:19:55,489
SURVIVAL, GROWTH, NEURODEVELOPMT

364
00:19:55,489 --> 00:19:57,891
AND LONG-TERM IMPACTS.

365
00:19:57,891 --> 00:19:59,359
THESE ARE THE THINGS THAT I WILL

366
00:19:59,359 --> 00:20:04,298
NOT DISCUSS BUT OTHER SPEAKERS

367
00:20:04,298 --> 00:20:09,770
WILL ADDRESS THIS TODAY.

368
00:20:09,770 --> 00:20:11,505
NEC DOES OCCUR PRIMARILY ALONG

369
00:20:11,505 --> 00:20:14,274
-- -- AMONG LOW BIRTH WEIGHT

370
00:20:14,274 --> 00:20:17,377
BABIES.

371
00:20:17,377 --> 00:20:22,449
MRS. DATA FROM THE DATABASE AND

372
00:20:22,449 --> 00:20:23,484
IT COMPRISES DATA FROM ALMOST

373
00:20:23,484 --> 00:20:25,352
1 MILLION INFANTS BORN OVER THE

374
00:20:25,352 --> 00:20:27,754
PAST 24 YEARS IN THE UNITED

375
00:20:27,754 --> 00:20:28,989
STATES AND IT SHOWS OVER THE

376
00:20:28,989 --> 00:20:32,960
TIME APPROXIMATELY 5 TO

377
00:20:32,960 --> 00:20:35,362
6 PERCENT OF VLBW BABIES

378
00:20:35,362 --> 00:20:42,903
SUFFERED NEC.

379
00:20:42,903 --> 00:20:47,241
WITH A RANGE.

380
00:20:47,241 --> 00:20:48,442
AND HER SOME INCREASES AND

381
00:20:48,442 --> 00:20:53,280
DECREASES OVER TIME.

382
00:20:53,280 --> 00:20:57,351
AND LOOKING AT THE DISTRIBUTION

383
00:20:57,351 --> 00:21:02,055
THIS IS DATA THAT IS VERY RECENT

384
00:21:02,055 --> 00:21:04,391
2 OR 3000 INFANTS AND HERE AGAIN

385
00:21:04,391 --> 00:21:09,730
THE MAIN 5 PERCENT SUFFERED

386
00:21:09,730 --> 00:21:14,034
NEC.

387
00:21:14,034 --> 00:21:15,202
BUT THERE IS A PROFOUND IMPACT

388
00:21:15,202 --> 00:21:16,737
AND A DIFFERENTIAL AROUND THE

389
00:21:16,737 --> 00:21:19,172
LOWEST GESTATION AROUND

390
00:21:19,172 --> 00:21:21,742
10 PERCENT OF KIDS BORN AT 23

391
00:21:21,742 --> 00:21:23,410
WEEKS SUFFERING THE

392
00:21:23,410 --> 00:21:23,744
COMPLICATION.

393
00:21:23,744 --> 00:21:26,980
AND THEN A LOWER RISK WITH

394
00:21:26,980 --> 00:21:30,717
GESTATION.

395
00:21:30,717 --> 00:21:33,353
I TRIED TO LOOK AT WHAT HAS

396
00:21:33,353 --> 00:21:34,588
CHANGED ARE TRYING TO CHANGE

397
00:21:34,588 --> 00:21:40,327
THINGS FOR THE BETTER.

398
00:21:40,327 --> 00:21:41,562
AND RECENTLY LOOKING AT A NUMBER

399
00:21:41,562 --> 00:21:45,165
OF OUTCOMES AT THE DATABASE TO

400
00:21:45,165 --> 00:21:47,467
SEE WHAT HAS GOTTEN BETTER AND

401
00:21:47,467 --> 00:21:52,272
WORSE AND DID SOME SOPHISTICATED

402
00:21:52,272 --> 00:21:55,742
CALCULATION AND LOOKING AT THE

403
00:21:55,742 --> 00:21:56,376
WAY NEC HAS CHANGED IN THE

404
00:21:56,376 --> 00:21:58,045
POPULATION.

405
00:21:58,045 --> 00:22:01,248
AND YOU CAN SEE HERE THERE WAS

406
00:22:01,248 --> 00:22:01,848
SOME TIME PERIOD WHERE WE MADE

407
00:22:01,848 --> 00:22:05,252
SIGNIFICANT IMPROVEMENTS WITH

408
00:22:05,252 --> 00:22:07,688
TRULY STATISTICAL SIGNIFICANT

409
00:22:07,688 --> 00:22:11,358
CHANGES BUT I HIGHLIGHT HERE IN

410
00:22:11,358 --> 00:22:15,963
YELLOW THAT IN RECENT YEARS

411
00:22:15,963 --> 00:22:18,765
THERE HAS BEEN NO ADVANCEMENTS

412
00:22:18,765 --> 00:22:21,969
IN THE POPULATION.

413
00:22:21,969 --> 00:22:24,304
WITH THE RESEARCH NETWORK ALSO

414
00:22:24,304 --> 00:22:29,309
PROVIDES WITH THE REACH DATA SET

415
00:22:29,309 --> 00:22:31,979
AND THIS IS DATA FROM THE

416
00:22:31,979 --> 00:22:39,620
NETWORK ALMOST 10000 AND LOW

417
00:22:39,620 --> 00:22:40,220
GESTATION INFANTS BECAUSE THE

418
00:22:40,220 --> 00:22:46,159
FOCUS IS ON THE LOWEST GESTATION

419
00:22:46,159 --> 00:22:46,760
HERE YOU CAN SEE AN AVERAGE OF

420
00:22:46,760 --> 00:22:47,394
ALMOST 9 PERCENT OF INFANTS BORN

421
00:22:47,394 --> 00:22:52,132
IN THE RANGE OF SUFFERED NEC

422
00:22:52,132 --> 00:22:52,766
WITH PROFOUND DIFFERENCES BY THE

423
00:22:52,766 --> 00:22:53,166
LOWEST GESTATION.

424
00:22:53,166 --> 00:22:56,603
HERE IN THIS DATA SET 15 PERCENT

425
00:22:56,603 --> 00:22:57,537
BORN THE 23rd WEEK SUFFERED

426
00:22:57,537 --> 00:23:01,208
THIS COMPLICATION AND HER OWN

427
00:23:01,208 --> 00:23:05,812
DATA SET WITH OVER 40 PERCENT OF

428
00:23:05,812 --> 00:23:06,613
THE INFANTS WHO SUFFERED NEC

429
00:23:06,613 --> 00:23:10,050
UNDERGO SURGERY AND THAT IS FOR

430
00:23:10,050 --> 00:23:10,917
THE MOST SEVERE FORMS OF THE

431
00:23:10,917 --> 00:23:16,556
DISEASE.

432
00:23:16,556 --> 00:23:17,157
THE NEONATAL RESEARCH NETWORK

433
00:23:17,157 --> 00:23:23,930
DID SOME COMPARATIVE STATISTICS

434
00:23:23,930 --> 00:23:24,498
WHERE THE MEAN WAS HIGHER IN

435
00:23:24,498 --> 00:23:25,565
THERE WAS A STATISTICALLY

436
00:23:25,565 --> 00:23:26,667
SIGNIFICANT SLIGHT IMPROVEMENT

437
00:23:26,667 --> 00:23:30,103
IN THE RATE BETWEEN THE 2 TIME

438
00:23:30,103 --> 00:23:39,813
PERIODS.

439
00:23:39,813 --> 00:23:40,447
SO THE AGENCIES GOT TOGETHER TO

440
00:23:40,447 --> 00:23:46,553
WROTE THE WHITE PAPER ON NEC.

441
00:23:46,553 --> 00:23:50,657
AND THAT REVIEWED THE MULTIPLE

442
00:23:50,657 --> 00:23:52,626
FURTHER ASSOCIATIONS THAT CAN BE

443
00:23:52,626 --> 00:23:54,628
SOUGHT WHO IS AT HIGHEST RISK

444
00:23:54,628 --> 00:24:05,105
AND WHAT COULD BE MODIFIED.

445
00:24:06,073 --> 00:24:07,040
AND THAT IS SLIGHTLY LOWER RISK

446
00:24:07,040 --> 00:24:14,181
OF NEC IS ASSOCIATED WITH RISK.

447
00:24:14,181 --> 00:24:20,220
AND THEN TO LARGELY COME DOWN

448
00:24:20,220 --> 00:24:21,254
INCREASED EXPOSURES TO HYPOXIA.

449
00:24:21,254 --> 00:24:24,024
NONE OF THIS THAT WE CAN

450
00:24:24,024 --> 00:24:26,460
MODIFY.

451
00:24:26,460 --> 00:24:28,962
WE SPEND A LOT OF TIME IN OUR

452
00:24:28,962 --> 00:24:29,796
FIELD WITH PRACTICE AND WHAT IS

453
00:24:29,796 --> 00:24:35,035
UNDER OUR CONTROL.

454
00:24:35,035 --> 00:24:36,570
MEDICATIONS, TRANSFUSION

455
00:24:36,570 --> 00:24:38,605
PRACTICES, OXYGEN SATURATION

456
00:24:38,605 --> 00:24:48,749
TARGETS.

457
00:24:59,626 --> 00:25:03,563
SO I WILL START WITH

458
00:25:03,563 --> 00:25:09,169
ANTIBIOTICS.

459
00:25:09,169 --> 00:25:09,770
ESSENTIALLY THIS WAS A KICK IN

460
00:25:09,770 --> 00:25:13,406
THE BUTT TO US WITH ANTIBIOTICS

461
00:25:13,406 --> 00:25:16,710
WITH VLBW BABIES AND IT LOOKS AT

462
00:25:16,710 --> 00:25:19,012
DETAIL OF ANTIBIOTIC PRACTICE

463
00:25:19,012 --> 00:25:25,986
BABIES BORN UNDER 1000 GRAMS AND

464
00:25:25,986 --> 00:25:26,586
NOW IT IS A 25 EURO DATA SET.

465
00:25:26,586 --> 00:25:27,554
AND IT SHOWED OVER 50 PERCENT OF

466
00:25:27,554 --> 00:25:29,523
THE BABIES WERE RECEIVING

467
00:25:29,523 --> 00:25:33,527
ANTIBIOTICS FROM BIRTH IN THE

468
00:25:33,527 --> 00:25:37,130
ANY ABSENCE OF INFECTION 1 OF

469
00:25:37,130 --> 00:25:37,697
THE THINGS THAT CAME OUT THE

470
00:25:37,697 --> 00:25:42,068
WORK WAS A DIFFERENTIAL AND THE

471
00:25:42,068 --> 00:25:43,203
USE RIGHT AFTER BIRTH AND THE

472
00:25:43,203 --> 00:25:46,540
SUBSEQUENT OUTCOME IN THIS PAPER

473
00:25:46,540 --> 00:25:47,507
WAS ESTIMATED THERE WAS A

474
00:25:47,507 --> 00:25:51,545
7 PERCENT INCREASE FOR EVERY

475
00:25:51,545 --> 00:25:56,550
ADDITIONAL DAY OF ANTIBODIES

476
00:25:56,550 --> 00:25:57,851
GIVEN DESPITE RISK OF INFECTION

477
00:25:57,851 --> 00:25:59,352
BUT NOT EVIDENCE.

478
00:25:59,352 --> 00:26:05,659
THERE IS A SIMILAR STUDY AND

479
00:26:05,659 --> 00:26:06,660
LOOKED QUANTITATIVELY AT THE

480
00:26:06,660 --> 00:26:15,502
RISK BETWEEN INCREASING NUMBERS

481
00:26:15,502 --> 00:26:16,069
OF ANTIBIOTICS STARTING FROM

482
00:26:16,069 --> 00:26:16,670
BIRTH AND ESTIMATED THAT WITH

483
00:26:16,670 --> 00:26:17,304
EACH ADDITIONAL DAY GIVEN THERE

484
00:26:17,304 --> 00:26:22,042
WAS AN INCREASED ODDS WITH THE

485
00:26:22,042 --> 00:26:22,676
THREEFOLD INCREASE GREATER THAN

486
00:26:22,676 --> 00:26:29,482
10 DAYS OF EXPOSURE.

487
00:26:29,482 --> 00:26:30,116
SOME THINGS HAVE GOTTEN BETTER I

488
00:26:30,116 --> 00:26:30,750
WOULD LIKE TO ARGUE THAT WE HAVE

489
00:26:30,750 --> 00:26:31,885
STARTED TO FOCUS ON PROPER USE

490
00:26:31,885 --> 00:26:38,592
OF ANTIBIOTICS AND FROM THE

491
00:26:38,592 --> 00:26:49,069
PREMIER DATA SET AND SHOWING

492
00:26:50,837 --> 00:26:51,371
THAT OVER TIME IN 2009 THROUGH

493
00:26:51,371 --> 00:26:51,905
2015 THERE HAVE BEEN SOME

494
00:26:51,905 --> 00:26:52,439
DECREASES IN STATISTICALLY

495
00:26:52,439 --> 00:26:54,007
SIGNIFICANT USE OF ANTIBIOTICS

496
00:26:54,007 --> 00:26:56,209
AND LOW BIRTH WEIGHT BABIES

497
00:26:56,209 --> 00:27:04,684
AMONG THE HIGHEST RISK.

498
00:27:04,684 --> 00:27:05,685
DOING SOME WORK IN THE MORE

499
00:27:05,685 --> 00:27:10,657
CONTEMPORARY DATA SET LOOKING AT

500
00:27:10,657 --> 00:27:11,224
WHETHER WE CONTINUE AND THE

501
00:27:11,224 --> 00:27:11,825
WIDESPREAD EARLY EXPOSURES AND

502
00:27:11,825 --> 00:27:18,765
FOUND THAT OVER TIME OF 22014 AT

503
00:27:18,765 --> 00:27:19,332
35 PERCENT GETTING PROLONGED

504
00:27:19,332 --> 00:27:24,037
ANTIBIOTICS AT BIRTH AND WITH

505
00:27:24,037 --> 00:27:24,638
THESE IMPROVEMENTS OF TARGETED

506
00:27:24,638 --> 00:27:25,572
ANTIBIOTICS WE DO SEE A LESSER

507
00:27:25,572 --> 00:27:33,613
ASSOCIATION WITH NEC THAT AS WE

508
00:27:33,613 --> 00:27:34,247
HAVE CLEANED UP OUR ACT PERHAPS

509
00:27:34,247 --> 00:27:34,881
WE ARE CONTRIBUTING LESS TO THE

510
00:27:34,881 --> 00:27:35,081
RISK.

511
00:27:35,081 --> 00:27:38,151
OF COURSE WE ARE WORRIED ABOUT

512
00:27:38,151 --> 00:27:42,022
INFECTION IS WHY WE GIVE

513
00:27:42,022 --> 00:27:42,789
ANTIBIOTICS AND PEOPLE HAVE DONE

514
00:27:42,789 --> 00:27:44,691
ENORMOUS AMOUNTS OF WORK TO FIND

515
00:27:44,691 --> 00:27:49,829
THE INFECTIOUS SMOKING GUN.

516
00:27:49,829 --> 00:28:00,040
LIKE TO SHOW THIS TABLE.

517
00:28:00,040 --> 00:28:00,674
AND YOU SEE THAT EACH INDIVIDUAL

518
00:28:00,674 --> 00:28:04,110
BACTERIA AND VIRUSES HAVE

519
00:28:04,110 --> 00:28:11,651
MULTIPLE REFERENCES ATTACHED.

520
00:28:11,651 --> 00:28:12,285
BUT IN FACT IN THE END SPECIFIC

521
00:28:12,285 --> 00:28:12,919
MICROBES ARE ASSOCIATED WITH NEC

522
00:28:12,919 --> 00:28:17,891
IN SINGLE SITE RARE OUTBREAKS

523
00:28:17,891 --> 00:28:19,526
AND CERTAINLY IT IS POSSIBLE

524
00:28:19,526 --> 00:28:22,929
THAT INFECTIONS ARE ASSOCIATED

525
00:28:22,929 --> 00:28:23,964
OR CAUSED OF THE COLONIZATION

526
00:28:23,964 --> 00:28:24,898
AND THEY COULD ALIGN WITH THE

527
00:28:24,898 --> 00:28:27,267
PATHOGENS CERTAINLY IN

528
00:28:27,267 --> 00:28:33,540
ACTIVATION OF THE TLR PATHWAY

529
00:28:33,540 --> 00:28:40,347
AND SOMETIMES AND COINCIDENT

530
00:28:40,347 --> 00:28:40,981
THAT IS PART OF THE SPECTRUM BUT

531
00:28:40,981 --> 00:28:42,549
IT IS FAIR TO SAY THE ROLE OF

532
00:28:42,549 --> 00:28:45,585
SPECIFIC SPECIES DESPITE MANY

533
00:28:45,585 --> 00:28:55,628
EFFORTS REMAINS UNCLEAR.

534
00:28:55,628 --> 00:28:56,262
ANOTHER AREA WHERE WE DON'T HAVE

535
00:28:56,262 --> 00:28:56,896
CLARITY ALTHOUGH WE ARE GETTING

536
00:28:56,896 --> 00:28:57,330
SOME IS IN THE MANY

537
00:28:57,330 --> 00:28:57,897
OBSERVATIONAL STUDIES THAT

538
00:28:57,897 --> 00:28:58,798
SUGGEST A RELATIONSHIP BETWEEN

539
00:28:58,798 --> 00:29:01,234
THE ADMINISTRATION OF RED BLOOD

540
00:29:01,234 --> 00:29:09,609
CELLS AND NEC IT HAS BEEN HIGHLY

541
00:29:09,609 --> 00:29:10,243
DEBATED AND PEOPLE IN OUR FIELD

542
00:29:10,243 --> 00:29:10,710
HAVE MADE ALL SORTS OF

543
00:29:10,710 --> 00:29:11,344
TRANSFUSION PRACTICES TO REDUCE

544
00:29:11,344 --> 00:29:14,681
THE RISK.

545
00:29:14,681 --> 00:29:15,949
BUT THE TRANSFUSION THE

546
00:29:15,949 --> 00:29:18,718
PREMATURITY STUDY COMPARED TO

547
00:29:18,718 --> 00:29:20,186
DIFFERENT A HEMOGLOBIN AND

548
00:29:20,186 --> 00:29:23,256
THRESHOLDS AMONG THE LOWEST

549
00:29:23,256 --> 00:29:23,723
BIRTH WEIGHT INFANTS.

550
00:29:23,723 --> 00:29:34,267
AND THE PRIMARY OUTCOME DID NOT

551
00:29:35,035 --> 00:29:35,602
FIND A DIFFERENCE BUT THE STUDY

552
00:29:35,602 --> 00:29:36,102
PARTICIPANTS DID ACHIEVE

553
00:29:36,102 --> 00:29:36,669
DIFFERENT HEMOGLOBIN LEVELS

554
00:29:36,669 --> 00:29:37,303
DURING THE STUDY AND FEWER UNITS

555
00:29:37,303 --> 00:29:41,241
OF BLOOD CELLS TRANSFUSED WITHIN

556
00:29:41,241 --> 00:29:41,775
HALF OF THE PARTICIPANTS.

557
00:29:41,775 --> 00:29:42,409
DESPITE THIS DIFFERENCE THE RATE

558
00:29:42,409 --> 00:29:51,718
OF NEC WAS NOT DIFFERENT IT WAS

559
00:29:51,718 --> 00:29:52,285
ABOUT THE 10 PERCENT WE HAVE

560
00:29:52,285 --> 00:29:52,852
SEEN IN PRIOR EPIDEMIOLOGIC

561
00:29:52,852 --> 00:29:53,353
STUDIES AND TO A RECENT

562
00:29:53,353 --> 00:29:53,853
SECONDARY ANALYSIS WITH

563
00:29:53,853 --> 00:29:54,454
TRANSFUSIONS GIVEN WITHIN THE

564
00:29:54,454 --> 00:29:56,356
STUDY ALSO FOUND NO ASSOCIATION

565
00:29:56,356 --> 00:30:06,800
THROUGH THE EVENT OF NEC.

566
00:30:15,608 --> 00:30:16,142
SO WE WILL GO INTO DETAIL THAT

567
00:30:16,142 --> 00:30:16,643
THIS IS THE PIECE OF THE

568
00:30:16,643 --> 00:30:17,277
PRACTICE TRULY UNDER OUR CONTROL

569
00:30:17,277 --> 00:30:17,844
AND HAS BEEN STUDIED IN MANY

570
00:30:17,844 --> 00:30:18,478
DIFFERENT CENTERS AND DIFFERENT

571
00:30:18,478 --> 00:30:19,079
WAYS AND I WILL POINT OUT THAT

572
00:30:19,079 --> 00:30:19,579
MOST OF THE STUDIES ARE

573
00:30:19,579 --> 00:30:23,483
ASSOCIATE - - ASSOCIATIONS AND

574
00:30:23,483 --> 00:30:24,117
DISCUSSIONS OF PRACTICE AND NOT

575
00:30:24,117 --> 00:30:24,684
TRIALS AND THIS IS 1 OF THE

576
00:30:24,684 --> 00:30:29,956
FIRST OUT OF THE MOUNTING

577
00:30:29,956 --> 00:30:30,523
HEALTHCARE SYSTEM WHERE ON A

578
00:30:30,523 --> 00:30:31,091
QUEUE I BASIS COMPARING THE

579
00:30:31,091 --> 00:30:36,596
RATES OF NEC AND THE SAME SYSTEM

580
00:30:36,596 --> 00:30:37,097
HAVING MANY OF THE SAME

581
00:30:37,097 --> 00:30:44,938
POSITIONS AND RESOURCES AND THEY

582
00:30:44,938 --> 00:30:45,572
OBSERVED AS YOU CAN SEE CENTER A

583
00:30:45,572 --> 00:30:46,206
HAD A 14 PERCENT RATE OF NEC AND

584
00:30:46,206 --> 00:30:47,373
THE OTHER 2 HAD MARKEDLY LOWER

585
00:30:47,373 --> 00:30:49,075
RATES.

586
00:30:49,075 --> 00:30:50,076
THE AUTHORS LOOKED AT MULTIPLE

587
00:30:50,076 --> 00:31:00,620
FACTORS STARTING WITH AN INFANT

588
00:31:06,392 --> 00:31:06,860
- - INFANTS AT THE CENTERS

589
00:31:06,860 --> 00:31:07,460
LOOKING AT MULTIPLE PRACTICES

590
00:31:07,460 --> 00:31:08,061
LOOKING AT WHETHER THE OUTCOME

591
00:31:08,061 --> 00:31:08,661
OF INFANTS WHO DID GET NICK --

592
00:31:08,661 --> 00:31:09,295
-- NEC WAS DIFFERENT IT WAS NOT

593
00:31:09,295 --> 00:31:09,796
BUT IT SHOWS A STRIKING

594
00:31:09,796 --> 00:31:10,430
DIFFERENCE OF FEEDING PROTOCOLS

595
00:31:10,430 --> 00:31:11,030
AND MOST IMPORTANTLY STRIKING

596
00:31:11,030 --> 00:31:13,099
DIFFERENCES IN THE USE MOTHER'S

597
00:31:13,099 --> 00:31:14,334
MILK VERSUS PRETERM FORMULA FOR

598
00:31:14,334 --> 00:31:21,174
FEEDING.

599
00:31:21,174 --> 00:31:21,774
SO THERE'S A LOT TO BE SET ON

600
00:31:21,774 --> 00:31:22,375
THE TOPIC BUT I WILL POINT OUT

601
00:31:22,375 --> 00:31:22,909
THE RECENT TRIAL WHICH WAS

602
00:31:22,909 --> 00:31:27,680
RANDOMIZED CONTROLLED STUDY OF

603
00:31:27,680 --> 00:31:28,314
INFANTS BORN UNDER 29 WEEKS OR

604
00:31:28,314 --> 00:31:28,915
THE BIRTH WEIGHT OF UNDER

605
00:31:28,915 --> 00:31:34,220
1000 GRAMS WERE RANDOMIZED TO

606
00:31:34,220 --> 00:31:34,787
USE OF DONOR MILK OR PRETERM

607
00:31:34,787 --> 00:31:38,057
FORMULA TO SUPPLEMENT.

608
00:31:38,057 --> 00:31:41,594
THE STUDIES PRIMARY OUTCOME

609
00:31:41,594 --> 00:31:44,097
WHICH IS A MEASURE OF COGNITIVE

610
00:31:44,097 --> 00:31:45,932
FUNCTION WITH THE SCALES OF

611
00:31:45,932 --> 00:31:48,201
INFANT DEVELOPMENT IS NOT

612
00:31:48,201 --> 00:31:52,071
DIFFERENT THE MORTALITY WAS NOT

613
00:31:52,071 --> 00:31:55,975
DIFFERENT BUT THE RATE OF NEC

614
00:31:55,975 --> 00:31:58,845
WAS DIFFERENT IN STATISTICALLY

615
00:31:58,845 --> 00:32:02,549
SIGNIFICANT AND HIGHLIGHTING 1

616
00:32:02,549 --> 00:32:04,784
OF THE MANY COMPLICATIONS OF THE

617
00:32:04,784 --> 00:32:11,224
TOPIC.

618
00:32:11,224 --> 00:32:11,858
BUT WE WILL HAVE A MORE DETAILED

619
00:32:11,858 --> 00:32:12,158
DISCUSSION.

620
00:32:12,158 --> 00:32:17,564
WHAT DO WE KNOW ABOUT NEC?

621
00:32:17,564 --> 00:32:19,499
IN MY CENTER OVER THE PAST 5

622
00:32:19,499 --> 00:32:25,638
YEARS WE HAVE QUITE DRACONIAN

623
00:32:25,638 --> 00:32:26,272
ANTIBIOTIC STEWARDSHIP GOING ON

624
00:32:26,272 --> 00:32:30,677
WITH FEEDING PROTOCOLS AND WIDE

625
00:32:30,677 --> 00:32:34,514
AVAILABILITY OF DONOR MILK TO

626
00:32:34,514 --> 00:32:38,585
SUPPORT MOTHER AND IT HAS BEEN

627
00:32:38,585 --> 00:32:43,289
3 PERCENT OVER 5 YEARS IT HAS

628
00:32:43,289 --> 00:32:44,524
BEEN IN STATISTICALLY LOWER THAN

629
00:32:44,524 --> 00:32:47,827
THE NATIONAL AVERAGE.

630
00:32:47,827 --> 00:32:48,895
SO I WORK CLINICALLY AS MANY AS

631
00:32:48,895 --> 00:32:51,864
YOU DO TWIN INFANTS WERE BORN AT

632
00:32:51,864 --> 00:32:55,768
28 WEEKS THIS YEAR.

633
00:32:55,768 --> 00:32:57,237
MOM WAS COMPLETE 1 WAS GROWTH

634
00:32:57,237 --> 00:33:02,976
RESTRICTED THE AGA TWIN WAS

635
00:33:02,976 --> 00:33:06,312
LARGELY MAINTAINED AND THEN GOT

636
00:33:06,312 --> 00:33:10,183
ANTIBIOTICS AND THE BASIS ONLY

637
00:33:10,183 --> 00:33:10,817
AFTER 24 HOURS AND WAS NEVER FED

638
00:33:10,817 --> 00:33:12,418
ANYTHING OTHER THAN MOTHER'S

639
00:33:12,418 --> 00:33:14,754
MILK AND DONOR MILK AND HUMAN

640
00:33:14,754 --> 00:33:22,095
MILK.

641
00:33:22,095 --> 00:33:22,629
CORRECTED GESTATIONAL AGE

642
00:33:22,629 --> 00:33:23,263
PRESENTED LETHARGY APNEA WITH A

643
00:33:23,263 --> 00:33:23,896
FULL EVALUATION AND EVENTUALLY

644
00:33:23,896 --> 00:33:31,738
DIAGNOSED WITH NEC AND SHOWING

645
00:33:31,738 --> 00:33:32,238
WIDESPREAD HEMATEMESIS.

646
00:33:32,238 --> 00:33:35,642
TREATED AND RECOVERED AND

647
00:33:35,642 --> 00:33:38,511
EVENTUALLY WENT HOME.

648
00:33:38,511 --> 00:33:44,117
BUT HE HAD A TWIN BROTHER WHO

649
00:33:44,117 --> 00:33:44,751
WAS GROWTH RESTRICTED WAS ALWAYS

650
00:33:44,751 --> 00:33:45,685
SECURE AT A HIGHER OXYGEN

651
00:33:45,685 --> 00:33:50,523
REQUIREMENT ULTIMATELY GETTING

652
00:33:50,523 --> 00:33:52,358
TREATMENT AND THE BABY NEVER

653
00:33:52,358 --> 00:33:54,594
DEVELOPED NEC AND ALSO

654
00:33:54,594 --> 00:33:59,365
EVENTUALLY WENT HOME.

655
00:33:59,365 --> 00:33:59,966
SUCCESS STORY PROBABLY BUT WE

656
00:33:59,966 --> 00:34:03,536
HAVE LEARNED A LOT AND WE KNOW

657
00:34:03,536 --> 00:34:07,573
VERY LITTLE.

658
00:34:07,573 --> 00:34:09,042
WHAT ARE SOME OF THE

659
00:34:09,042 --> 00:34:18,618
CONSEQUENCES IF YOU DO GET NEC?

660
00:34:18,618 --> 00:34:19,252
I WILL SHOW A SERIES OF STUDIES

661
00:34:19,252 --> 00:34:19,819
THAT IS A NEONATAL RESEARCH

662
00:34:19,819 --> 00:34:20,420
NETWORK THAT HAS BEEN ABLE TO

663
00:34:20,420 --> 00:34:23,056
HARNESS THE POWDER POWER OF

664
00:34:23,056 --> 00:34:23,656
CLINICAL DATA WITH A DETAILED

665
00:34:23,656 --> 00:34:26,392
FOLLOW-UP DATA.

666
00:34:26,392 --> 00:34:28,928
THIS IS WORK OUT OF OUR OLD

667
00:34:28,928 --> 00:34:32,532
COHORT 1995 TO 1998 WITH A BIRTH

668
00:34:32,532 --> 00:34:33,232
WEIGHT UNDER 1000 GRAMS ALMOST

669
00:34:33,232 --> 00:34:38,204
5000 INFANTS AS COLLEAGUES AND

670
00:34:38,204 --> 00:34:38,805
COMPARED INFANTS THAT DID NOT

671
00:34:38,805 --> 00:34:41,574
SUFFER NEC AND THOSE WHO GOT

672
00:34:41,574 --> 00:34:52,118
MEDICAL NEC OR SURGICAL NEC AND

673
00:34:52,318 --> 00:34:52,885
THE GROWTH DURING THE NICU TIME

674
00:34:52,885 --> 00:34:53,519
ENDING AT 2 YEARS AND AS YOU CAN

675
00:34:53,519 --> 00:34:54,087
SEE THERE WERE SIGNIFICANT

676
00:34:54,087 --> 00:34:54,654
IMPACTS, NEGATIVE IMPACTS ON

677
00:34:54,654 --> 00:35:01,627
BOTH WEIGHT, LENGTH AND HEAD

678
00:35:01,627 --> 00:35:02,228
CIRCUMFERENCE WITH THE RISK OF

679
00:35:02,228 --> 00:35:02,729
BEING AT LESS THAN TENTH

680
00:35:02,729 --> 00:35:03,563
PERCENTILE STATISTICALLY

681
00:35:03,563 --> 00:35:08,901
SIGNIFICANTLY GREATER WHEN YOU

682
00:35:08,901 --> 00:35:09,502
COMPARE INFANTS TO HAD NO NEC

683
00:35:09,502 --> 00:35:10,069
VERSUS SURGICAL NEC ALTHOUGH

684
00:35:10,069 --> 00:35:10,670
INTERESTINGLY NOT SIGNIFICANT

685
00:35:10,670 --> 00:35:12,305
DIFFERENCE BETWEEN THOSE WHO HAD

686
00:35:12,305 --> 00:35:18,211
MEDICAL NEC.

687
00:35:18,211 --> 00:35:18,644
IN ADDITION TO THESE

688
00:35:18,644 --> 00:35:19,445
INVESTIGATORS LOOK AT TWO-YEAR

689
00:35:19,445 --> 00:35:23,583
NEURODEVELOPMENT OUTCOME AND

690
00:35:23,583 --> 00:35:24,217
WITH A LITTLE BIT OF AN OLDER

691
00:35:24,217 --> 00:35:24,817
DEFINITION COMPARED TO WHAT WE

692
00:35:24,817 --> 00:35:30,390
USE NOW, THESE INVESTIGATORS CAN

693
00:35:30,390 --> 00:35:38,798
SHOW SIGNIFICANT DIFFERENCE IN

694
00:35:38,798 --> 00:35:39,399
THE COMBINED RATE OF DEATH OR

695
00:35:39,399 --> 00:35:40,032
SURVIVAL WITH MODERATE TO SEVERE

696
00:35:40,032 --> 00:35:40,666
NEURODEVELOPMENT IMPAIRMENT WHEN

697
00:35:40,666 --> 00:35:43,836
COMPARING THOSE THAT HAVE NO NEC

698
00:35:43,836 --> 00:35:44,203
TO SURGICAL NEC.

699
00:35:44,203 --> 00:35:50,243
I REALLY WANT TO CALL OUT THIS.

700
00:35:50,243 --> 00:35:50,743
IT'S EASY TO GET LOST IN

701
00:35:50,743 --> 00:35:51,377
DEFINITIONS AND ADJUSTMENTS OF

702
00:35:51,377 --> 00:35:54,614
STATISTICS.

703
00:35:54,614 --> 00:35:59,118
LOOK AT DEATH AND THIS COHORT IF

704
00:35:59,118 --> 00:35:59,652
YOU WERE A BABY BORN UNDER

705
00:35:59,652 --> 00:36:02,388
1000 GRAMS AND DID NOT SUFFER 1

706
00:36:02,388 --> 00:36:11,030
OUT OF 5 DIED BEFORE DISCHARGE

707
00:36:11,030 --> 00:36:11,664
IF YOU HAD ANY NEC THE RISK WAS

708
00:36:11,664 --> 00:36:12,265
TWICE AS HIGH OF 40 PERCENT IF

709
00:36:12,265 --> 00:36:12,899
YOU HAD SURGICAL NEC IT WAS EVEN

710
00:36:12,899 --> 00:36:16,202
HIGHER THAN MEDICAL.

711
00:36:16,202 --> 00:36:16,836
WITH A DEVASTATING COMPLICATION

712
00:36:16,836 --> 00:36:22,642
OF PREMATURITY.

713
00:36:22,642 --> 00:36:23,276
AS OF THE PARTICULAR ASSOCIATION

714
00:36:23,276 --> 00:36:25,812
WITH SURGICAL NEC MANY STUDIES

715
00:36:25,812 --> 00:36:27,246
FOCUSED ON THE GROUP THAT HAS

716
00:36:27,246 --> 00:36:29,015
HAD SURGERY FOR NEC THIS IS A

717
00:36:29,015 --> 00:36:35,154
LITTLE MORE CONTEMPORARY

718
00:36:35,154 --> 00:36:35,721
FOCUSING ON THOSE BORN UNDER

719
00:36:35,721 --> 00:36:36,322
1000 GRAMS COMPARING THOSE WHO

720
00:36:36,322 --> 00:36:36,989
HAD NO NEC OR SPONTANEOUS

721
00:36:36,989 --> 00:36:46,232
INTESTINAL PERFORATION.

722
00:36:46,232 --> 00:36:46,899
AND WITH A COMBINED OUTCOME AND

723
00:36:46,899 --> 00:36:48,000
HERE WE CAN SEE ALL OF THE

724
00:36:48,000 --> 00:36:51,604
COMPARISONS SURGICAL NEC VERSUS

725
00:36:51,604 --> 00:36:55,675
NO NEC WERE MARKEDLY HIGHER

726
00:36:55,675 --> 00:36:58,611
RATES OF OVER 80 PERCENT OF

727
00:36:58,611 --> 00:37:09,121
NEURODEVELOPMENTAL IMPAIRMENT.

728
00:37:14,260 --> 00:37:14,827
>> YOU NEVER KNOW WHEN
SOMETHING

729
00:37:14,827 --> 00:37:15,394
WILL SHOW UP SO THERE WAS A

730
00:37:15,394 --> 00:37:15,928
COMPARISON LOOKING AT THE

731
00:37:15,928 --> 00:37:16,562
OUTCOMES ASSOCIATED IF THEY HAD

732
00:37:16,562 --> 00:37:21,067
GOT IN BETTER.

733
00:37:21,067 --> 00:37:24,570
AND ON THE ADJUSTED ANALYSIS

734
00:37:24,570 --> 00:37:30,576
2012 THROUGH 2016 THERE IS

735
00:37:30,576 --> 00:37:31,110
ACTUALLY NO IMPROVEMENT IN

736
00:37:31,110 --> 00:37:38,284
NOTHING GOOD HAS CHANGE.

737
00:37:38,284 --> 00:37:38,851
AND USING MORE CONTEMPORARY

738
00:37:38,851 --> 00:37:39,418
DEFINITIONS OF IMPAIRMENT AT

739
00:37:39,418 --> 00:37:43,055
90 PERCENT OF INFANTS.

740
00:37:43,055 --> 00:37:43,489
THEY SUFFER DEATH OR

741
00:37:43,489 --> 00:37:50,997
NEURODEVELOPMENTAL IMPAIRMENT.

742
00:37:50,997 --> 00:37:51,531
WITH THOSE CONSEQUENCES OF

743
00:37:51,531 --> 00:37:55,067
HAVING NEC OR SURGICAL NEC WHICH

744
00:37:55,067 --> 00:38:00,406
IS SHORT BOWEL SYNDROME AND THE

745
00:38:00,406 --> 00:38:02,708
OUTCOMES OF THAT THOSE BORN LOW

746
00:38:02,708 --> 00:38:07,613
GESTATION COMPARING THOSE THOSE

747
00:38:07,613 --> 00:38:15,254
THAT HAD HERE WE CAN SEE THE

748
00:38:15,254 --> 00:38:22,261
COMBINED OUTCOME WAS MORE COMMON

749
00:38:22,261 --> 00:38:24,664
AMONG THOSE WHO HAD SHORT BOWEL

750
00:38:24,664 --> 00:38:28,100
SYNDROME AND EVERY MEASURE OF

751
00:38:28,100 --> 00:38:31,804
SURVIVAL WAS STATISTICALLY

752
00:38:31,804 --> 00:38:35,875
SIGNIFICANTLY WORSE.

753
00:38:35,875 --> 00:38:46,152
IF YOU SURVIVED.

754
00:38:48,955 --> 00:38:50,790
THE FAMILY IS BEING THERE LIVES

755
00:38:50,790 --> 00:38:51,958
WITH THE CONDITIONS AT THE LEAD

756
00:38:51,958 --> 00:39:02,134
THE NICU.

757
00:39:05,338 --> 00:39:07,807
AND BASED ON A CONVENIENCE

758
00:39:07,807 --> 00:39:18,351
SAMPLE AND HAS MANY LIMITATIONS

759
00:39:19,085 --> 00:39:19,652
THAT STUDIES DO PARTICULARLY THE

760
00:39:19,652 --> 00:39:20,186
FOLKS WHO RESPONDED TO THE

761
00:39:20,186 --> 00:39:30,730
SURVEY WERE NON-HISPANIC WHITE.

762
00:39:31,130 --> 00:39:31,731
AND I WAS INTERESTED TO KNOW IT

763
00:39:31,731 --> 00:39:32,598
WASN'T ALWAYS THE TINY LOW

764
00:39:32,598 --> 00:39:42,908
GESTATION INFANTS.

765
00:39:43,542 --> 00:39:44,110
THOSE THAT WHO HAD SURVIVED NEC

766
00:39:44,110 --> 00:39:44,610
AS WELL AS WELL AS ADULT

767
00:39:44,610 --> 00:39:50,149
SURVIVORS THAT RESPONDED AND I

768
00:39:50,149 --> 00:39:50,750
KNOW YOU CANNOT READ A LOT OF

769
00:39:50,750 --> 00:39:51,350
THIS BUT I WOULD RECOMMEND YOU

770
00:39:51,350 --> 00:39:56,288
LOOK AT THIS PAPER.

771
00:39:56,288 --> 00:39:56,889
IT IS A GOOD DESCRIPTION USING

772
00:39:56,889 --> 00:40:01,494
QUALITATIVE SURVEY METHODS TO

773
00:40:01,494 --> 00:40:02,094
REFLECT THE REALITY OF LIVING

774
00:40:02,094 --> 00:40:06,499
AFTER THE DIAGNOSIS OF NEC.

775
00:40:06,499 --> 00:40:08,100
MANY OF THE ITEMS THAT STOOD OUT

776
00:40:08,100 --> 00:40:10,803
TO ME INCLUDED THE LONG-TERM

777
00:40:10,803 --> 00:40:15,441
PHYSICAL EFFECTS WITH CONSTANT

778
00:40:15,441 --> 00:40:17,810
WORRIES OF G.I. FUNCTION AND

779
00:40:17,810 --> 00:40:23,482
GROSS THE SOCIAL IMPLICATIONS OF

780
00:40:23,482 --> 00:40:24,116
BEING A TEENAGER WHO IS CONSTANT

781
00:40:24,116 --> 00:40:27,186
WORRIES WHERE THE BATHROOM IS

782
00:40:27,186 --> 00:40:27,820
AND INTERESTINGLY THE LACK OF

783
00:40:27,820 --> 00:40:30,890
INFORMATION AROUND NEC AND THE

784
00:40:30,890 --> 00:40:36,095
EXTENT TO WHICH THE FEW ADULT

785
00:40:36,095 --> 00:40:39,732
SURVIVORS FELT THEY HAD TO

786
00:40:39,732 --> 00:40:40,366
REPEATEDLY DISCUSS THIS AND TELL

787
00:40:40,366 --> 00:40:43,335
THEIR PEDIATRICIAN THAT THEY ARE

788
00:40:43,335 --> 00:40:44,937
NOT IMAGINING THEIR SYMPTOMS

789
00:40:44,937 --> 00:40:46,072
ESPECIALLY WHEN THEY

790
00:40:46,072 --> 00:40:52,111
TRANSITIONED INTO ADULT CARE.

791
00:40:52,111 --> 00:40:55,114
LOOKING AT A FEW SPECIFIC

792
00:40:55,114 --> 00:40:57,750
OUTCOMES THE RATE OF ANY

793
00:40:57,750 --> 00:41:01,654
LONG-TERM IMPLICATION WAS

794
00:41:01,654 --> 00:41:12,098
60 PERCENT ON THE SURVEY.

795
00:41:12,698 --> 00:41:13,199
IT WAS ONLY A QUARTER OF THE

796
00:41:13,199 --> 00:41:17,470
RESPONDENTS AND 17 PERCENT WERE

797
00:41:17,470 --> 00:41:18,037
STILL RECEIVING INTRAVENOUS

798
00:41:18,037 --> 00:41:22,975
SUPPLEMENTAL MUCH NUTRITION.

799
00:41:22,975 --> 00:41:25,511
AT NEGATIVELY IMPACTED THE

800
00:41:25,511 --> 00:41:28,013
HEALTH OF THE PARENTS 74 PERCENT

801
00:41:28,013 --> 00:41:30,750
OF THE RESPONDENTS SAID THAT IT

802
00:41:30,750 --> 00:41:40,826
DID.

803
00:41:41,560 --> 00:41:42,128
FOR THE REST OF THE DAY YOU CAN

804
00:41:42,128 --> 00:41:42,595
TAKE ON THIS MESSAGE.

805
00:41:42,595 --> 00:41:43,195
NEC IS A TERRIBLE COMPLICATION

806
00:41:43,195 --> 00:41:43,729
OF EXTREME PREMATURITY AND

807
00:41:43,729 --> 00:41:45,798
OCCURS BETWEEN 5 THEIR 6 PERCENT

808
00:41:45,798 --> 00:41:48,234
BORN UNDER 1500 GRAMS 10 PERCENT

809
00:41:48,234 --> 00:41:54,073
UNDER 1000 GRAMS.

810
00:41:54,073 --> 00:41:54,673
THERE HAVE BEEN SOME DECREASES

811
00:41:54,673 --> 00:41:55,608
IN NEC OVER THE PAST 20 TO 30

812
00:41:55,608 --> 00:41:58,344
YEARS ALTHOUGH IMPROVEMENTS HAVE

813
00:41:58,344 --> 00:41:59,545
PLATEAUED OVER THE LAST 5 TO 10

814
00:41:59,545 --> 00:42:01,614
YEARS AND THAT CONTINUES TO

815
00:42:01,614 --> 00:42:03,983
OCCUR DESPITE MANY EFFORTS TO

816
00:42:03,983 --> 00:42:09,021
IDENTIFY BEST PRACTICES.

817
00:42:09,021 --> 00:42:10,156
APPROXIMATELY TWOFOLD RISK OF

818
00:42:10,156 --> 00:42:14,927
DEATH INCREASED ASSOCIATED WITH

819
00:42:14,927 --> 00:42:15,561
SURGICAL NEC A GOOD 1.5 PERCENT

820
00:42:15,561 --> 00:42:18,130
OF NEURODEVELOPMENTAL IMPAIR 

821
00:42:18,130 --> 00:42:18,430
IMPAIRMENT.

822
00:42:18,430 --> 00:42:18,998
THE OUTCOMES ARE MOST SEVERE

823
00:42:18,998 --> 00:42:21,634
AMONG THOSE WITH SURGICAL NEC

824
00:42:21,634 --> 00:42:27,039
AND THOSE WITH SHORT BOWEL

825
00:42:27,039 --> 00:42:27,306
SYNDROME.

826
00:42:27,306 --> 00:42:27,840
WE ARE ONLY BEGINNING TO

827
00:42:27,840 --> 00:42:31,811
UNDERSTAND THE LIFELONG IMPACTS

828
00:42:31,811 --> 00:42:34,413
OF THE COMPLICATIONS AND I AM

829
00:42:34,413 --> 00:42:40,352
HAPPY TO BE AT A CONFERENCE THAT

830
00:42:40,352 --> 00:42:40,953
IS TRYING AS HARD AS WE CAN TO

831
00:42:40,953 --> 00:42:41,453
CONTINUE TO PREVENT THIS

832
00:42:41,453 --> 00:42:41,921
TERRIBLE COMPLICATION.

833
00:42:41,921 --> 00:42:43,255
THANK YOU.

834
00:42:43,255 --> 00:42:51,197
[APPLAUSE]

835
00:42:51,197 --> 00:42:51,530
>> THANK YOU.

836
00:42:51,530 --> 00:42:51,931
I APPRECIATE THAT.

837
00:42:51,931 --> 00:43:02,441
OUR NEXT SPEAKER DOCTOR PATEL

838
00:43:02,641 --> 00:43:03,175
PROFESSOR OF PEDIATRICS IN THE

839
00:43:03,175 --> 00:43:03,676
DIVISION OF NEONATOLOGY

840
00:43:03,676 --> 00:43:04,276
UNIVERSITY SCHOOL OF MEDICINE

841
00:43:04,276 --> 00:43:04,777
CHILDREN'S HEALTHCARE OF

842
00:43:04,777 --> 00:43:05,010
ATLANTA.

843
00:43:05,010 --> 00:43:06,478
TAKE IT AWAY.

844
00:43:06,478 --> 00:43:13,686
>> THANK YOU TO FDA AND
NIH I

845
00:43:13,686 --> 00:43:15,354
LIKE TO ECHO THE COMMENTS ON THE

846
00:43:15,354 --> 00:43:19,692
STAKEHOLDERS BRING IN THOSE

847
00:43:19,692 --> 00:43:20,292
TOGETHER TO ADDRESS A TERRIBLE

848
00:43:20,292 --> 00:43:20,526
DISEASE.

849
00:43:20,526 --> 00:43:20,993
I WILL TALK ABOUT THE

850
00:43:20,993 --> 00:43:25,297
NUTRITIONAL APPROACHES AND

851
00:43:25,297 --> 00:43:25,931
SUPPLEMENTATION PRACTICES AMONG

852
00:43:25,931 --> 00:43:26,498
LOW BIRTH WEIGHT INFANTS AND

853
00:43:26,498 --> 00:43:27,633
WHEN THE THINGS I WAS TALK ASKED

854
00:43:27,633 --> 00:43:33,172
TO TALK ABOUT WITH THE

855
00:43:33,172 --> 00:43:33,739
RECOMMENDATIONS OF CARE SO I

856
00:43:33,739 --> 00:43:34,240
WILL TALK ABOUT CURRENT

857
00:43:34,240 --> 00:43:34,874
RECOMMENDATIONS OF CARE AS WELL

858
00:43:34,874 --> 00:43:35,174
AS EVIDENCE.

859
00:43:35,174 --> 00:43:39,411
A FEW DISCLOSURES THE CONTRACT

860
00:43:39,411 --> 00:43:43,115
RESEARCH ORGANIZATION FOR TRIAL

861
00:43:43,115 --> 00:43:47,486
THERAPEUTICS AND THE CONSULTANT

862
00:43:47,486 --> 00:43:48,120
I WILL DISCUSS THAT AS WELL

863
00:43:48,120 --> 00:43:51,957
TODAY AND BRIEFLY DISCUSSING

864
00:43:51,957 --> 00:43:52,558
PROBIOTICS THIS IS NOT FOR THE

865
00:43:52,558 --> 00:43:59,465
PREVENTION OF DISEASES AND I'M

866
00:43:59,465 --> 00:44:00,099
ALSO SPEAKING HERE ON BEHALF OF

867
00:44:00,099 --> 00:44:00,733
MYSELF AND NOT ANY ORGANIZATION

868
00:44:00,733 --> 00:44:03,702
THAT COULD BE AFFILIATED.

869
00:44:03,702 --> 00:44:14,213
MY GOAL TODAY IS TO TALK ABOUT

870
00:44:14,647 --> 00:44:15,214
THE RECOMMENDATIONS BUT CURRENT

871
00:44:15,214 --> 00:44:15,848
GUIDANCE IN TERMS OF NUTRITIONAL

872
00:44:15,848 --> 00:44:16,482
SUPPLEMENTATION PRACTICES AS IT

873
00:44:16,482 --> 00:44:17,049
RELATES TO LOW BIRTH WEIGHT

874
00:44:17,049 --> 00:44:17,583
INFANTS AND HIGHLIGHTS THE

875
00:44:17,583 --> 00:44:19,852
EVIDENCE OF WHAT I CAN IN THE

876
00:44:19,852 --> 00:44:20,352
TIME THAT WE HAVE OF THE

877
00:44:20,352 --> 00:44:22,588
EVIDENCE OF IMPACT NUTRITION ON

878
00:44:22,588 --> 00:44:27,393
NEC FOR VLBW INFANTS AND THEN

879
00:44:27,393 --> 00:44:31,897
THE SUPPLEMENTATION PRACTICES

880
00:44:31,897 --> 00:44:32,431
AND WHAT ARE THOSE IN THE

881
00:44:32,431 --> 00:44:39,505
NEONATAL INTENSIVE CARE UNITS.

882
00:44:39,505 --> 00:44:40,105
SO TO BEGIN WITH WHAT ARE SOME

883
00:44:40,105 --> 00:44:40,606
GUIDANCE ON NUTRITIONAL

884
00:44:40,606 --> 00:44:46,011
APPROACHES IN SUPPLEMENTATION'S

885
00:44:46,011 --> 00:44:46,645
AS IT RELATES TO THE TOPIC TODAY

886
00:44:46,645 --> 00:44:47,279
FOR PROBIOTICS THAT ARE RELEVANT

887
00:44:47,279 --> 00:44:48,547
FOR PRACTICING CLINICIANS IN THE

888
00:44:48,547 --> 00:44:53,819
US AND ELSEWHERE?

889
00:44:53,819 --> 00:44:58,724
SO I WILL START WITH GUIDANCE

890
00:44:58,724 --> 00:44:59,358
AND HERE IS A CLINICAL REPORT ON

891
00:44:59,358 --> 00:45:02,294
THE GUIDANCE FOR HUMAN MILK

892
00:45:02,294 --> 00:45:05,497
TITLED PROMOTING HUMAN MILK AND

893
00:45:05,497 --> 00:45:06,832
BREASTMILK FOR THE LOW BIRTH

894
00:45:06,832 --> 00:45:14,807
WEIGHT INFANTS AND AS IT RELATES

895
00:45:14,807 --> 00:45:15,441
TO NEC WITH OPTIMAL NUTRITION IT

896
00:45:15,441 --> 00:45:15,908
DECREASES THE RISK OF

897
00:45:15,908 --> 00:45:16,508
SIGNIFICANT COMPLICATIONS OF

898
00:45:16,508 --> 00:45:24,116
PREMATURITY AND FEEDING IS

899
00:45:24,116 --> 00:45:24,750
RECOMMENDED FOR LOW BIRTH WEIGHT

900
00:45:24,750 --> 00:45:25,484
INFANTS AND IS INSUFFICIENT OR

901
00:45:25,484 --> 00:45:27,019
CONTRAINDICATED.

902
00:45:27,019 --> 00:45:28,520
THERE ARE RACIAL AND ETHNIC

903
00:45:28,520 --> 00:45:33,559
DISPARITIES FOR VERY LOW BIRTH

904
00:45:33,559 --> 00:45:36,095
WEIGHT INFANTS AND FREQUENTLY

905
00:45:36,095 --> 00:45:37,796
REQUIRES FORTIFICATION TO MEET

906
00:45:37,796 --> 00:45:43,335
THE NEEDS OF THE INFANTS.

907
00:45:43,335 --> 00:45:46,472
IN ADDITION WITH GUIDANCE

908
00:45:46,472 --> 00:45:51,176
PUBLISHED IN 2021 THERE ARE 4

909
00:45:51,176 --> 00:45:52,745
KEY POINTS AND I COPY THESE

910
00:45:52,745 --> 00:45:54,913
VERBATIM AND THE FIRST IS THAT

911
00:45:54,913 --> 00:46:00,185
THE CURRENT EVIDENCE IT DOES NOT

912
00:46:00,185 --> 00:46:05,090
SUPPORT PARTICULARLY THOSE WITH

913
00:46:05,090 --> 00:46:05,958
A BIRTH WEIGHT OF LESS THAN

914
00:46:05,958 --> 00:46:08,594
1000 GRAMS.

915
00:46:08,594 --> 00:46:09,228
IT ALSO GOES ON TO GIVE SPECIFIC

916
00:46:09,228 --> 00:46:11,530
RECOMMENDATIONS FOR CENTERS THAT

917
00:46:11,530 --> 00:46:12,998
ARE MAKING THE DECISION TO

918
00:46:12,998 --> 00:46:15,701
ADMINISTER PROBIOTICS BUT IF

919
00:46:15,701 --> 00:46:18,537
THEY DO THAT THEY SHOULD DISCUSS

920
00:46:18,537 --> 00:46:21,573
THE RISKS AND BENEFITS SO THEY

921
00:46:21,573 --> 00:46:24,009
SHOULD CONSIDER A CONSENT

922
00:46:24,009 --> 00:46:25,577
PROCESS AND SHOULD DEVELOP LOCAL

923
00:46:25,577 --> 00:46:29,415
GUIDELINES FOR THOSE TO ASSESS

924
00:46:29,415 --> 00:46:32,384
LOCAL IMPACTS AND THE CLINICIAN

925
00:46:32,384 --> 00:46:33,585
SHOULD BE AWARE OF THE LACK OF

926
00:46:33,585 --> 00:46:42,895
REGULATORY STANDARDS AND YOU

927
00:46:42,895 --> 00:46:43,529
HEARD AN EXCELLENT INTRODUCTION

928
00:46:43,529 --> 00:46:44,129
ON LBP'S AND THE REGULATION OF

929
00:46:44,129 --> 00:46:46,198
THESE.

930
00:46:46,198 --> 00:46:51,703
THEN FOR ADVERSE EVENT AND

931
00:46:51,703 --> 00:46:52,538
SAFETY.

932
00:46:52,538 --> 00:47:03,082
BUT THEN THE WHO HAS GUIDELINES

933
00:47:06,151 --> 00:47:06,652
THAT WERE BROADENED FOR THE

934
00:47:06,652 --> 00:47:07,286
GLOBAL COMMUNITY TO HIGHLIGHT AS

935
00:47:07,286 --> 00:47:07,820
IT RELATES TO THE TOPIC OF

936
00:47:07,820 --> 00:47:08,353
NUTRITIONAL PRACTICES AND

937
00:47:08,353 --> 00:47:08,987
SUPPLEMENTS THE RECOMMENDATIONS

938
00:47:08,987 --> 00:47:09,655
FOR THE CARE OF LOW BIRTH WEIGHT

939
00:47:09,655 --> 00:47:10,189
INFANTS SOME OF THESE WERE

940
00:47:10,189 --> 00:47:14,693
CONTINUING DISCONTINUATIONS 11

941
00:47:14,693 --> 00:47:15,727
ARE STRONG RECOMMENDATIONS BUT

942
00:47:15,727 --> 00:47:16,962
THEN SEVERAL NEW RECOMMENDATIONS

943
00:47:16,962 --> 00:47:21,366
THAT AS 1 THAT WERE CONDITIONAL

944
00:47:21,366 --> 00:47:25,070
THAT WE WILL TOUCH ON THIS

945
00:47:25,070 --> 00:47:25,704
BRIEFLY AS IT IS RELEVANT TO THE

946
00:47:25,704 --> 00:47:26,271
AREAS OF NUTRITION AND

947
00:47:26,271 --> 00:47:30,242
SUPPLEMENTATION BUT ALSO THE

948
00:47:30,242 --> 00:47:31,110
AMERICAN ACADEMY OF PEDIATRICS.

949
00:47:31,110 --> 00:47:41,587
THE W JOE RECOMMENDS FEEDING

950
00:47:41,787 --> 00:47:42,321
MOTHERS MILK THAT IS A STRONG

951
00:47:42,321 --> 00:47:42,921
RECOMMENDATION IN MY MOTHER'S

952
00:47:42,921 --> 00:47:43,555
OWN MILK IS NOT AVAILABLE THOSE

953
00:47:43,555 --> 00:47:44,156
THAT IS CONSIDERED FOR FEEDING

954
00:47:44,156 --> 00:47:45,858
IS CONSIDERED RECOMMENDATION

955
00:47:45,858 --> 00:47:46,492
ALSO FORTIFICATION SPECIFICALLY

956
00:47:46,492 --> 00:47:50,829
FOR THE POPULATION FOR VERY LOW

957
00:47:50,829 --> 00:47:51,663
BIRTH WEIGHT INFANTS TO BE

958
00:47:51,663 --> 00:47:53,265
CONSIDERED AND WHEN MOTHER'S OWN

959
00:47:53,265 --> 00:47:55,534
MILK ARE NOT AVAILABLE THERE IS

960
00:47:55,534 --> 00:47:57,669
A RECOMMENDATION FOR PRETERM

961
00:47:57,669 --> 00:48:02,508
FORMULA.

962
00:48:02,508 --> 00:48:03,142
VERY PRETERM BUT THE SUPPLEMENTS

963
00:48:03,142 --> 00:48:03,609
THERE ARE A NUMBER OF

964
00:48:03,609 --> 00:48:05,110
RECOMMENDATIONS FOR IRON AND

965
00:48:05,110 --> 00:48:07,613
ZINC VITAMIN A SUPPLEMENTATION

966
00:48:07,613 --> 00:48:10,916
BUT THESE ALSO MIRROR GUIDANCE

967
00:48:10,916 --> 00:48:15,654
FROM THE AMERICAN ACADEMY OF

968
00:48:15,654 --> 00:48:18,690
PEDIATRICS THEN FINALLY THE WHO

969
00:48:18,690 --> 00:48:19,258
HAS A NEW RECOMMENDATION FOR

970
00:48:19,258 --> 00:48:20,392
2023 PROBIOTICS COULD BE

971
00:48:20,392 --> 00:48:21,693
CONSIDERED FOR HUMAN MILK WITH

972
00:48:21,693 --> 00:48:25,697
PRETERM INFANTS THIS IS BASED ON

973
00:48:25,697 --> 00:48:28,500
OTHER EVIDENCE AND WITH

974
00:48:28,500 --> 00:48:29,468
SUPPLEMENTS THE NEXT STUDY ALSO

975
00:48:29,468 --> 00:48:32,271
HAS GUIDANCE NOTED AS A STRATEGY

976
00:48:32,271 --> 00:48:36,608
TO HELP THE DEUCE NEC AND DEATH

977
00:48:36,608 --> 00:48:37,176
AND LOW BIRTH WEIGHT INFANTS

978
00:48:37,176 --> 00:48:42,014
THERE IS A GROWING INTEREST IN

979
00:48:42,014 --> 00:48:42,648
FAMILY SHOULD BE BETTER INFORMED

980
00:48:42,648 --> 00:48:46,785
OF RISKS AND BENEFITS CLINICIAN

981
00:48:46,785 --> 00:48:47,819
SHOULD BE PREPARED TO HAVE

982
00:48:47,819 --> 00:48:52,491
PARENTS UNDERSTAND THE RATIONALE

983
00:48:52,491 --> 00:48:53,125
AND THEN DETAILED IMPLEMENTATION

984
00:48:53,125 --> 00:48:55,027
AND CAREFUL DATA COLLECTION ARE

985
00:48:55,027 --> 00:48:56,395
ESSENTIAL TO CONTINUOUSLY TRACK

986
00:48:56,395 --> 00:49:01,567
AND UNDERSTAND PROBIOTIC USE OR

987
00:49:01,567 --> 00:49:02,100
THE LACK THEREOF AND THEN

988
00:49:02,100 --> 00:49:04,036
FINALLY AS IT RELATES TO

989
00:49:04,036 --> 00:49:06,505
GUIDANCE HERE IN THE UNITED

990
00:49:06,505 --> 00:49:07,706
STATES GASTRIN ELEGY ASSOCIATION

991
00:49:07,706 --> 00:49:13,946
IN 2020 TALKED ABOUT LESS THAN

992
00:49:13,946 --> 00:49:14,546
37 WEEKS OF GESTATION AND THEN

993
00:49:14,546 --> 00:49:15,347
WE SUGGEST THEY PROVIDE CERTAIN

994
00:49:15,347 --> 00:49:20,118
TYPES OF PRODUCTS WITH DIFFERENT

995
00:49:20,118 --> 00:49:20,652
TYPES OF BACTERIA THAT ARE

996
00:49:20,652 --> 00:49:22,287
LISTED HERE WITH A

997
00:49:22,287 --> 00:49:23,722
RECOMMENDATION FOR THE

998
00:49:23,722 --> 00:49:25,257
PREVENTION AND THIS WAS A

999
00:49:25,257 --> 00:49:27,426
CONDITIONAL RECOMMENDATION BASED

1000
00:49:27,426 --> 00:49:31,396
ON HIGH CERTAINTY OF EVIDENCE

1001
00:49:31,396 --> 00:49:32,297
WITH EUROPEAN SOCIETY FOR

1002
00:49:32,297 --> 00:49:35,000
GASTROENTEROLOGY AND NUTRITION

1003
00:49:35,000 --> 00:49:36,568
THAT ALSO HAS CONDITIONAL

1004
00:49:36,568 --> 00:49:39,438
RECOMMENDATIONS SO I JUST WANT

1005
00:49:39,438 --> 00:49:41,707
TO START THEIR 1 OF THE THINGS I

1006
00:49:41,707 --> 00:49:45,711
WAS ASKED TO TALK ABOUT OF

1007
00:49:45,711 --> 00:49:51,316
RECOMMENDED CARE WITH THE

1008
00:49:51,316 --> 00:49:51,817
GUIDANCE THAT CLINICIANS

1009
00:49:51,817 --> 00:49:52,451
PRACTICING IN UNITS RELATING TO

1010
00:49:52,451 --> 00:49:55,020
VERY LOW BIRTH WEIGHT UNITS IS

1011
00:49:55,020 --> 00:49:56,588
EXPRESSED TO TALK ABOUT THE

1012
00:49:56,588 --> 00:49:59,625
EVIDENCE OF THE NUTRITIONAL

1013
00:49:59,625 --> 00:50:00,292
APPROACHES AND YOU HEARD SOME OF

1014
00:50:00,292 --> 00:50:00,892
THIS FROM THE EXCELLENT

1015
00:50:00,892 --> 00:50:05,530
PRESENTATION AND I WILL REPEAT

1016
00:50:05,530 --> 00:50:08,900
SOME OF THIS BUT IT IS IMPORTANT

1017
00:50:08,900 --> 00:50:09,935
MANY OF THE SNOW THE BENEFITS OF

1018
00:50:09,935 --> 00:50:17,676
HUMAN MILK THIS WAS PUBLISHED IN

1019
00:50:17,676 --> 00:50:18,277
2009 FROM THE RESEARCH NETWORK

1020
00:50:18,277 --> 00:50:22,581
LOOKING AT OVER TIME ON THE X

1021
00:50:22,581 --> 00:50:23,582
AXIS LOOKING AT THE

1022
00:50:23,582 --> 00:50:27,252
PROPORTIONATE INFANTS WHO

1023
00:50:27,252 --> 00:50:31,957
SURVIVE FREE OF ANY CNA

1024
00:50:31,957 --> 00:50:32,591
CORRESPOND TO THE PROPORTION OF

1025
00:50:32,591 --> 00:50:33,191
HUMAN MILK INTAKE IN THE FIRST

1026
00:50:33,191 --> 00:50:39,931
14 DAYS OF LIFE THAT THEY

1027
00:50:39,931 --> 00:50:40,532
RECEIVE EXCLUSIVELY ALL HUMAN

1028
00:50:40,532 --> 00:50:42,334
MILK 75 PERCENT, 50 AND

1029
00:50:42,334 --> 00:50:44,436
25 PERCENT WITH THE TAKE-HOME

1030
00:50:44,436 --> 00:50:45,037
MESSAGE HUMAN MILK IS A VERY

1031
00:50:45,037 --> 00:50:48,640
IMPORTANT FACTOR WITH THE IMPACT

1032
00:50:48,640 --> 00:50:50,976
ON NEC THE HIGHER THE DOORS --

1033
00:50:50,976 --> 00:50:55,347
-- THE DOSE TO LOWER THE RISK.

1034
00:50:55,347 --> 00:50:58,317
OF COURSE RECOMMENDATIONS ARE

1035
00:50:58,317 --> 00:51:03,155
FOR MOTHERS ON MILK.

1036
00:51:03,155 --> 00:51:06,925
SO RANDOMIZING DESIGNS ON TRIALS

1037
00:51:06,925 --> 00:51:11,330
TO THE MOTHER'S OWN APPEARANCE

1038
00:51:11,330 --> 00:51:12,164
THIS IS WHY OBSERVATION DATA CAN

1039
00:51:12,164 --> 00:51:17,502
BE USEFUL TO QUANTIFY THE DATA.

1040
00:51:17,502 --> 00:51:19,438
WHAT ABOUT ODOR MELT - - DONOR

1041
00:51:19,438 --> 00:51:20,072
MELT?

1042
00:51:20,072 --> 00:51:30,048
IS NOT ALWAYS AVAILABLE THIS IS

1043
00:51:30,048 --> 00:51:30,615
A REVIEW THAT HIGHLIGHTS THE

1044
00:51:30,615 --> 00:51:33,151
DATA FROM RECENT CLINICAL TRIALS

1045
00:51:33,151 --> 00:51:35,620
ON THE EFFECTIVE DONOR HUMAN

1046
00:51:35,620 --> 00:51:42,160
MILK AND WHEN IT SHOWS THAT THE

1047
00:51:42,160 --> 00:51:45,731
USE OF DONOR HUMAN MILK RESULTED

1048
00:51:45,731 --> 00:51:56,141
IN A REDUCTION OF ABOUT

1049
00:51:58,844 --> 00:51:59,411
53 PERCENT AND THAT IS BASED ON

1050
00:51:59,411 --> 00:51:59,945
HIGH CERTAINTY EVIDENCE 11

1051
00:51:59,945 --> 00:52:00,579
STUDIES OF 2200 INFANTS INVOLVED

1052
00:52:00,579 --> 00:52:01,179
BUT IF THERE IS NO SIGNIFICANT

1053
00:52:01,179 --> 00:52:04,549
EFFECTS OF LATE ONSET INFECTION

1054
00:52:04,549 --> 00:52:05,050
-- -- INFECTION OF THE

1055
00:52:05,050 --> 00:52:05,317
ANALYSIS.

1056
00:52:05,317 --> 00:52:06,585
1 OF THE LARGEST TRIALS

1057
00:52:06,585 --> 00:52:09,688
CONTRIBUTING TO THAT ANALYSIS IS

1058
00:52:09,688 --> 00:52:13,225
THE RESEARCH NETWORK MILK TRIALS

1059
00:52:13,225 --> 00:52:14,626
MULTI- SET OF RANDOMIZED CONTROL

1060
00:52:14,626 --> 00:52:18,363
TRIALS INVOKING INFANTS WITH THE

1061
00:52:18,363 --> 00:52:19,798
BIRTH WEIGHT LESS THAN

1062
00:52:19,798 --> 00:52:26,571
1000 GRAMS SO THIS WAS DONE FROM

1063
00:52:26,571 --> 00:52:27,038
SEPTEMBER 2012 THROUGH

1064
00:52:27,038 --> 00:52:27,639
MARCH 2019 IT TOOK A NUMBER OF

1065
00:52:27,639 --> 00:52:29,174
YEARS BUT AN IMPORTANT TRIAL IT

1066
00:52:29,174 --> 00:52:34,079
IS IMPORTANT POPULATION THOSE

1067
00:52:34,079 --> 00:52:34,713
THAT ARE HIGHEST RISK SOMETIMES

1068
00:52:34,713 --> 00:52:38,717
THEY DO TAKE A WHILE TO ENROLL

1069
00:52:38,717 --> 00:52:39,317
WITH THE PURPOSE OF THE TRIAL

1070
00:52:39,317 --> 00:52:39,918
WAS TO LOOK AT THE EFFECTS OF

1071
00:52:39,918 --> 00:52:42,687
DONOR HUMAN MILK WITH COGNITIVE

1072
00:52:42,687 --> 00:52:44,289
OUTCOME THERE WAS NO SIGNIFICANT

1073
00:52:44,289 --> 00:52:47,893
DIFFERENCE THAT WE LOOKED AT THE

1074
00:52:47,893 --> 00:52:54,966
TRIAL AND THE REDUCTION AND WAS

1075
00:52:54,966 --> 00:52:59,638
DEFINED TO GREATER WITH A

1076
00:52:59,638 --> 00:53:00,138
5 PERCENT ABSOLUTE RISK

1077
00:53:00,138 --> 00:53:00,772
REDUCTION CORRESPONDING TO WHAT

1078
00:53:00,772 --> 00:53:04,843
YOU WOULD EXPECT BASED ON THE

1079
00:53:04,843 --> 00:53:05,644
PRIOR SYSTEMATIC REVIEW ABOUT A

1080
00:53:05,644 --> 00:53:07,446
50 PERCENT REDUCTION OF AN

1081
00:53:07,446 --> 00:53:12,984
EASY.

1082
00:53:12,984 --> 00:53:13,618
SO WHAT ABOUT OTHER NUTRITIONAL

1083
00:53:13,618 --> 00:53:13,885
PRACTICES?

1084
00:53:13,885 --> 00:53:18,590
THERE ARE THINGS AS IT RELATES

1085
00:53:18,590 --> 00:53:19,224
TO ENTERAL FEEDING AND NUTRITION

1086
00:53:19,224 --> 00:53:21,693
I WANT TO HIGHLIGHT A RECENT

1087
00:53:21,693 --> 00:53:26,965
WORKGROUP IN AUGUST OF THIS YEAR

1088
00:53:26,965 --> 00:53:33,638
THAT CONVENED A WORKGROUP OF THE

1089
00:53:33,638 --> 00:53:34,206
NATIONAL ADVISORY COUNCIL OF

1090
00:53:34,206 --> 00:53:37,843
HEALTH AND HUMAN DEVELOPMENT.

1091
00:53:37,843 --> 00:53:38,477
1 OF THE THINGS THEY WERE TASKED

1092
00:53:38,477 --> 00:53:41,713
WITH WAS TO CITE THE SCIENTIFIC

1093
00:53:41,713 --> 00:53:45,417
EVIDENCE AND THEN TO INCREASE

1094
00:53:45,417 --> 00:53:55,594
THE RISK.

1095
00:53:56,928 --> 00:53:57,395
BUT THEN TO HIGHLIGHT THE

1096
00:53:57,395 --> 00:53:57,963
FINDINGS FROM THIS REPORT I

1097
00:53:57,963 --> 00:53:58,430
THINK ARE RELEVANT FOR

1098
00:53:58,430 --> 00:53:58,997
NUTRITIONAL PRACTICES AS IT

1099
00:53:58,997 --> 00:53:59,598
RELATES TO THE OUTCOME WE ARE

1100
00:53:59,598 --> 00:54:00,799
INTERESTED IN TODAY.

1101
00:54:00,799 --> 00:54:05,237
THESE ARE SOME OF THE POINTS AND

1102
00:54:05,237 --> 00:54:15,413
YOU CAN LOOK BELOW BUT THE

1103
00:54:15,413 --> 00:54:15,981
RELATIONSHIP THE FEEDING AND

1104
00:54:15,981 --> 00:54:16,615
DEVELOPMENT OF NEC IS NOT CLEAR

1105
00:54:16,615 --> 00:54:17,249
BUT EVIDENCE TODAY SUPPORTS THE

1106
00:54:17,249 --> 00:54:17,849
HYPOTHESIS THE ABSENCE OF ANY

1107
00:54:17,849 --> 00:54:24,990
HUMAN MILK IS THE HIGH RISK AND

1108
00:54:24,990 --> 00:54:25,590
WE KNOW FROM STUDIES DISCUSSED

1109
00:54:25,590 --> 00:54:26,191
AS PART OF THE STUDY THERE'S A

1110
00:54:26,191 --> 00:54:26,791
NUMBER OF COMPONENT OF ASPECTS

1111
00:54:26,791 --> 00:54:27,425
AND A NUMBER OF COMPONENTS THAT

1112
00:54:27,425 --> 00:54:32,197
HAVE BEEN STUDIED THAT CONFIRM

1113
00:54:32,197 --> 00:54:33,031
BENEFIT AND THERE IS A NEED FOR

1114
00:54:33,031 --> 00:54:41,239
ADDITIONAL RESEARCH UNDERLYING

1115
00:54:41,239 --> 00:54:41,773
MECHANISMS THAT CAUSE THE

1116
00:54:41,773 --> 00:54:42,340
SPECIFIC COMPONENTS TO HELP

1117
00:54:42,340 --> 00:54:42,908
PREVENT IT AND WE NEED MORE

1118
00:54:42,908 --> 00:54:43,508
STUDIES TO DETERMINE WHY HUMAN

1119
00:54:43,508 --> 00:54:47,979
MILK AND NEC USE HAS A PERTINENT

1120
00:54:47,979 --> 00:54:50,949
EXAMPLE.

1121
00:54:50,949 --> 00:54:53,552
THIS TALK ALSO TOUCHES ON OTHER

1122
00:54:53,552 --> 00:54:58,924
ASPECTS LIKE TO USE THE STANDARD

1123
00:54:58,924 --> 00:54:59,558
OBSERVATIONAL STUDIES AS WELL AS

1124
00:54:59,558 --> 00:55:03,562
SOME OF THE DISCUSSIONS ON THE

1125
00:55:03,562 --> 00:55:04,162
APPROACHES TO FORTIFICATION IN

1126
00:55:04,162 --> 00:55:04,763
THE IMPACT BUT I WILL NOT GET

1127
00:55:04,763 --> 00:55:15,040
INTO THAT TODAY.

1128
00:55:16,441 --> 00:55:16,942
FINALLY I WILL TOUCH ON THE

1129
00:55:16,942 --> 00:55:17,576
EVIDENCE FOR SUPPLEMENTATION AND

1130
00:55:17,576 --> 00:55:18,176
PRACTICES OF LOW BIRTH WEIGHT

1131
00:55:18,176 --> 00:55:18,810
INFANTS IF YOU THINK OF THIS IN

1132
00:55:18,810 --> 00:55:19,277
TERMS OF THE SCOPE OF

1133
00:55:19,277 --> 00:55:19,878
SUPPLEMENTATION AND PRACTICES

1134
00:55:19,878 --> 00:55:23,615
THIS IS A BROAD SUPPLEMENTATION

1135
00:55:23,615 --> 00:55:27,819
AND THIS IS A REVIEW THAT LOOKS

1136
00:55:27,819 --> 00:55:30,922
AT SUPPLEMENTATION THAT MIGHT

1137
00:55:30,922 --> 00:55:33,825
HAVE AN IMPACT ON MICRO BIOME

1138
00:55:33,825 --> 00:55:38,163
HEALTH AND IT SEEMS THAT THE

1139
00:55:38,163 --> 00:55:40,365
TERMINOLOGY MAY BE DIFFERENT

1140
00:55:40,365 --> 00:55:46,137
THAN THOSE MENTIONED EARLIER

1141
00:55:46,137 --> 00:55:46,771
FROM THOSE PRODUCTS BUT AS WELL

1142
00:55:46,771 --> 00:55:49,274
AS OTHER NUTRITIONAL SUPPLEMENTS

1143
00:55:49,274 --> 00:55:50,775
THAT SOME OF THESE ARE ROUTINELY

1144
00:55:50,775 --> 00:55:52,477
ADMINISTERED WITH LOW BIRTH

1145
00:55:52,477 --> 00:55:57,749
WEIGHT INFANTS BUT TO TOUCH ON

1146
00:55:57,749 --> 00:56:03,922
THE ASPECTS OF SUPPLEMENTATION.

1147
00:56:03,922 --> 00:56:04,956
THINK OF NUTRITIONAL

1148
00:56:04,956 --> 00:56:11,463
SUPPLEMENTATION PROBIOTICS ARE

1149
00:56:11,463 --> 00:56:14,733
SELECTIVE TO HOST MICROORGA 

1150
00:56:14,733 --> 00:56:15,333
MICROORGANISMS.

1151
00:56:15,333 --> 00:56:25,877
AND HUMAN MILK CAN SUPPORT OR BE

1152
00:56:26,544 --> 00:56:27,612
UTILIZED BY THOSE MICROORGANISMS

1153
00:56:27,612 --> 00:56:29,047
THOSE BIO BIOTICS THAT HAVE BEEN

1154
00:56:29,047 --> 00:56:33,051
STUDIED IN SPECIFIC TRIALS AND

1155
00:56:33,051 --> 00:56:35,620
SOME STUDIES HAVE MIXTURES AND

1156
00:56:35,620 --> 00:56:39,090
THEN NOT YET TO MY KNOWLEDGE

1157
00:56:39,090 --> 00:56:41,860
HAVE BEEN EVALUATED TO DATE IN

1158
00:56:41,860 --> 00:56:45,063
TERMS OF NONVIABLE PRODUCTS THAT

1159
00:56:45,063 --> 00:56:47,132
HAVE BEEN WITH THE LOW BIRTH

1160
00:56:47,132 --> 00:56:53,571
WEIGHT POPULATION THAT ALSO

1161
00:56:53,571 --> 00:57:00,979
COULD BE A STRATEGY THAT ABOUT

1162
00:57:00,979 --> 00:57:06,418
THE SUPPLEMENTATION?

1163
00:57:06,418 --> 00:57:07,018
THIS IS A SNAPSHOT I WAS A IS

1164
00:57:07,018 --> 00:57:07,619
NOT REFLECTIVE OF THE CURRENT

1165
00:57:07,619 --> 00:57:14,926
STATE BUT THIS IS DATA THAT IS

1166
00:57:14,926 --> 00:57:15,560
PUBLISHED REPORTS AND THE FIRST

1167
00:57:15,560 --> 00:57:16,061
IS ON THE LEFT PUBLISHED

1168
00:57:16,061 --> 00:57:17,462
2020, GROUP AT DUKE THAT

1169
00:57:17,462 --> 00:57:18,263
UTILIZED THE WAREHOUSE WHICH IS

1170
00:57:18,263 --> 00:57:22,867
DATA FROM A NUMBER OF UNITS

1171
00:57:22,867 --> 00:57:24,335
LOOKING AT TRENDS AND YOU CAN

1172
00:57:24,335 --> 00:57:30,041
SEE THE INCREASE AFTER 2014

1173
00:57:30,041 --> 00:57:30,542
THERE WAS AN INCREASE OF

1174
00:57:30,542 --> 00:57:34,512
PROBIOTIC YOU SUPPLEMENTATION

1175
00:57:34,512 --> 00:57:37,182
AND BASED ON THE 2022 SURVEY

1176
00:57:37,182 --> 00:57:45,023
PUBLISHED LAST YEAR ABOUT 1

1177
00:57:45,023 --> 00:57:46,057
THIRD REPORTED USE IN A GROUP OF

1178
00:57:46,057 --> 00:57:49,360
CHILDREN'S HOSPITAL UNITS AS

1179
00:57:49,360 --> 00:57:54,332
WELL AS MANAGED BY THE

1180
00:57:54,332 --> 00:57:56,868
PROBIOTICS GROUP THERE WAS SOME

1181
00:57:56,868 --> 00:58:00,605
GUIDANCE ABOUT 30 PERCENT OF

1182
00:58:00,605 --> 00:58:02,040
UNITS AND ABOUT 1 THIRD AT THE

1183
00:58:02,040 --> 00:58:08,580
TIME WERE CONSIDERING FOR

1184
00:58:08,580 --> 00:58:09,147
INITIATION AND A VARIETY OF

1185
00:58:09,147 --> 00:58:09,614
COMMERCIALLY AVAILABLE

1186
00:58:09,614 --> 00:58:14,085
SUPPLEMENTS THAT WERE USED IN

1187
00:58:14,085 --> 00:58:14,686
THE NICU AND I HIGHLIGHT THIS

1188
00:58:14,686 --> 00:58:16,721
YEAR WITH THE SURVEY THAT WAS

1189
00:58:16,721 --> 00:58:19,457
PUBLISHED SOME OF THESE ARE NO

1190
00:58:19,457 --> 00:58:20,091
LONGER AVAILABLE ON THE MARKET.

1191
00:58:20,091 --> 00:58:21,726
AS PART OF ROUTINE USE YOU HEARD

1192
00:58:21,726 --> 00:58:25,597
ABOUT THE NETWORK THESE GROUPS

1193
00:58:25,597 --> 00:58:26,030
HAVE HAD A CHANCE TO

1194
00:58:26,030 --> 00:58:36,574
CHARACTERIZE THE EXPERIMENTS THE

1195
00:58:39,444 --> 00:58:40,011
EXPERIENCE OF THE IMPLEMENTATION

1196
00:58:40,011 --> 00:58:40,645
AND PRACTICE I WILL NOT GET INTO

1197
00:58:40,645 --> 00:58:41,246
MUCH MORE DETAIL WE WILL TALK

1198
00:58:41,246 --> 00:58:41,880
ABOUT THIS AFTER LUNCH IN TERMS

1199
00:58:41,880 --> 00:58:42,514
OF EVIDENCE BUT I HIGHLIGHT THIS

1200
00:58:42,514 --> 00:58:44,883
BECAUSE 1 OF THE THINGS AS IT

1201
00:58:44,883 --> 00:58:45,416
RELATES TO HUMAN MILK AND

1202
00:58:45,416 --> 00:58:46,050
FEEDING PRACTICES IS THE ABILITY

1203
00:58:46,050 --> 00:58:49,921
TO LOOK AT THE POTENTIAL THE

1204
00:58:49,921 --> 00:58:50,355
ASSOCIATION ROUTINE

1205
00:58:50,355 --> 00:58:50,955
SUPPLEMENTATION AND THOSE WHO

1206
00:58:50,955 --> 00:59:01,432
DID NOT RECEIVE HUMAN MILK.

1207
00:59:03,968 --> 00:59:04,536
SIMILARLY GROUPS HAVE BEEN ABLE

1208
00:59:04,536 --> 00:59:05,170
TO CHARACTERIZE THE ASSOCIATION

1209
00:59:05,170 --> 00:59:05,804
BETWEEN ROUTINE SUPPLEMENTATION

1210
00:59:05,804 --> 00:59:06,404
OF THESE PRODUCTS IN THE NICU

1211
00:59:06,404 --> 00:59:07,038
AND THE PRODUCT THAT IS SHOWN ON

1212
00:59:07,038 --> 00:59:08,406
THE RIGHT FOR EXAMPLE A LOWER

1213
00:59:08,406 --> 00:59:15,647
REDUCTION THAT IS REPORTED FROM

1214
00:59:15,647 --> 00:59:15,847
2020.

1215
00:59:15,847 --> 00:59:16,414
AND FINALLY THE NUTRITIONAL

1216
00:59:16,414 --> 00:59:20,885
SUPPLEMENTATION AND PRACTICES

1217
00:59:20,885 --> 00:59:21,486
ARE A VARIETY OF DIFFERENT

1218
00:59:21,486 --> 00:59:22,086
SUPPLEMENTS AND I WILL NOT GO

1219
00:59:22,086 --> 00:59:24,789
INTO DETAIL ON EACH BUT THE

1220
00:59:24,789 --> 00:59:31,029
SUPPLEMENTS THAT ARE USED AND

1221
00:59:31,029 --> 00:59:31,496
THESE ARE SOME OF THE

1222
00:59:31,496 --> 00:59:35,200
EXAMPLES, VITAMIN A WAS A TRIAL

1223
00:59:35,200 --> 00:59:35,800
LAID BY THE NEONATAL RESEARCH

1224
00:59:35,800 --> 00:59:38,403
UNIT IN 1999 SHOWING

1225
00:59:38,403 --> 00:59:42,173
INTRAMUSCULARLY REDUCED

1226
00:59:42,173 --> 00:59:44,442
DYSPLASIA THAT IS ROUTINELY USED

1227
00:59:44,442 --> 00:59:52,917
VITAMIN D AND IRON INCLUDING FOR

1228
00:59:52,917 --> 00:59:53,518
THE PREVENTION OF RICKETS AND

1229
00:59:53,518 --> 00:59:54,152
VITAMIN A SUPPLEMENTATION IS NOT

1230
00:59:54,152 --> 00:59:54,752
ROUTINE BUT HAS BEEN STUDIED

1231
00:59:54,752 --> 00:59:57,689
PREVIOUSLY FOR HEMORRHAGE BUT IS

1232
00:59:57,689 --> 00:59:59,991
NOT USED OF SOME CONCERNS OF

1233
00:59:59,991 --> 01:00:03,561
SEPSIS AND THEN THERE ARE

1234
01:00:03,561 --> 01:00:06,898
STUDIES TO SUPPLEMENT DHA AND

1235
01:00:06,898 --> 01:00:12,503
STUDIES SHOW AN INCREASE OF

1236
01:00:12,503 --> 01:00:13,137
COMPLICATIONS SUCH AS DYSPLASIA

1237
01:00:13,137 --> 01:00:13,671
OR LUNG DISEASE IMPROVING

1238
01:00:13,671 --> 01:00:17,475
COGNITIVE OUTCOME.

1239
01:00:17,475 --> 01:00:22,547
BEGINNING WITH THE WHO

1240
01:00:22,547 --> 01:00:23,014
SUGGESTION OF ROUTINE

1241
01:00:23,014 --> 01:00:23,615
SUPPLEMENTATION OF ZINC COULD

1242
01:00:23,615 --> 01:00:26,618
REDUCE MORTALITY AND THEN SOME

1243
01:00:26,618 --> 01:00:33,925
SMALL CLINICAL TRIALS SHOW THAT

1244
01:00:33,925 --> 01:00:35,326
COULD HAVE A POTENTIAL

1245
01:00:35,326 --> 01:00:37,528
REDUCTIONS SO WITH THOSE

1246
01:00:37,528 --> 01:00:41,532
SUPPLEMENTS AND THEN TO BE

1247
01:00:41,532 --> 01:00:45,937
EVALUATED SO WITH A SNAPSHOT

1248
01:00:45,937 --> 01:00:52,543
WORD ARE THE PRACTICES AND WITH

1249
01:00:52,543 --> 01:00:53,511
MANY OF THE DATA THAT WE

1250
01:00:53,511 --> 01:00:56,180
DISCUSSED THIS FAR BETWEEN

1251
01:00:56,180 --> 01:01:05,323
INFANTS AT 20 WEEKS OF GESTATION

1252
01:01:05,323 --> 01:01:05,857
AND THIS IS DATA FROM 2013

1253
01:01:05,857 --> 01:01:06,491
THROUGH 2018 AND WHEN WE LOOK AT

1254
01:01:06,491 --> 01:01:07,091
HUMAN MILK USE OF THE FIRST 20

1255
01:01:07,091 --> 01:01:09,327
DAYS OF BIRTH IF YOU LOOK AT THE

1256
01:01:09,327 --> 01:01:12,897
DENOMINATOR BABIES THAT ARE FED

1257
01:01:12,897 --> 01:01:13,498
MOST CURRENTLY IF YOU LOOK AT

1258
01:01:13,498 --> 01:01:15,767
THE PRACTICE OF RECEIVING MILK

1259
01:01:15,767 --> 01:01:22,740
IS PART OF ROUTINE CARE AND THE

1260
01:01:22,740 --> 01:01:25,209
SUPPLEMENTATION COHORT IS ABOUT

1261
01:01:25,209 --> 01:01:28,446
10 PERCENT THEY ARE RECEIVING

1262
01:01:28,446 --> 01:01:29,080
SUPPLEMENTATION ABOUT 25 PERCENT

1263
01:01:29,080 --> 01:01:35,853
OF THE CENTERS I WON'T GO INTO

1264
01:01:35,853 --> 01:01:36,454
TOO MUCH DETAIL BUT TO SAY THE

1265
01:01:36,454 --> 01:01:40,992
RISK OF NEC IS 9 PERCENT LOOKING

1266
01:01:40,992 --> 01:01:42,126
AT SEPSIS BUT THEN I HIGHLIGHT

1267
01:01:42,126 --> 01:01:46,030
THE NUMBERS THIS IS JUST 15

1268
01:01:46,030 --> 01:01:46,664
CENTERS OVER THE PERIOD OF TIME

1269
01:01:46,664 --> 01:01:49,567
THAT MEANS 890 BABIES DEVELOPED

1270
01:01:49,567 --> 01:01:54,238
AND HAD TO HAVE SURGERY ALMOST

1271
01:01:54,238 --> 01:01:57,942
2000 WITH LATE ONSET SEPSIS.

1272
01:01:57,942 --> 01:01:59,444
SO WHEN WE TALK ABOUT

1273
01:01:59,444 --> 01:02:04,282
PERCENTAGES THIS REFLECTS REAL

1274
01:02:04,282 --> 01:02:04,882
PATIENCE AND THAT IS IMPORTANT

1275
01:02:04,882 --> 01:02:05,616
TO THINK ABOUT THE DATA THESE

1276
01:02:05,616 --> 01:02:07,885
ARE REAL PATIENTS IMPACTED BY

1277
01:02:07,885 --> 01:02:15,326
THESE DISEASES.

1278
01:02:15,326 --> 01:02:15,960
AND THEN LOOK AT MORTALITY AS WE

1279
01:02:15,960 --> 01:02:20,665
THINK OF THE CAUSE OF DEATH IN

1280
01:02:20,665 --> 01:02:23,167
BETWEEN 2 WEEKS AND 2 MONTHS OF

1281
01:02:23,167 --> 01:02:26,637
LIFE IT IS A SINGLE CAUSE OF

1282
01:02:26,637 --> 01:02:29,874
DEATH IT REALLY ACCOUNTS FOR THE

1283
01:02:29,874 --> 01:02:31,209
MAJORITY BETWEEN 2 WEEKS AND 2

1284
01:02:31,209 --> 01:02:31,743
MONTHS OF LIFE AND THEN OF

1285
01:02:31,743 --> 01:02:36,280
COURSE SOME OF THESE IT COULD

1286
01:02:36,280 --> 01:02:36,881
CONTRIBUTE TO MORBIDITIES THAT

1287
01:02:36,881 --> 01:02:41,686
COULD BE A CAUSE OF DEATH SO

1288
01:02:41,686 --> 01:02:43,121
THAT MEANS A TRAGIC DISEASE AND

1289
01:02:43,121 --> 01:02:47,825
GLAD WE ARE HERE TODAY TO

1290
01:02:47,825 --> 01:02:50,728
IMPLEMENT AND WITH THE

1291
01:02:50,728 --> 01:02:55,433
APPEARANCE OF MELCHOR DONOR MILK

1292
01:02:55,433 --> 01:02:56,534
AND ALTHOUGH GUIDANCE FOR

1293
01:02:56,534 --> 01:03:03,508
DIFFERENT GROUPS HUMAN MILK

1294
01:03:03,508 --> 01:03:06,411
FEEDING I THINK IT IS AN

1295
01:03:06,411 --> 01:03:08,880
IMPORTANT FACTOR IMPORTANT

1296
01:03:08,880 --> 01:03:09,781
AGAINST THE RISK AND A VARIETY

1297
01:03:09,781 --> 01:03:14,052
OF SUPPLEMENTS INCLUDING

1298
01:03:14,052 --> 01:03:15,153
PROBIOTICS HAVE BEEN EVALUATED

1299
01:03:15,153 --> 01:03:17,221
AND THEY ARE ROUTINELY USED HERE

1300
01:03:17,221 --> 01:03:17,688
IN THE UNITED STATES.

1301
01:03:17,688 --> 01:03:27,865
THANK YOU.

1302
01:03:32,103 --> 01:03:33,271
>> I WOULD LIKE TO INVITE
OUR

1303
01:03:33,271 --> 01:03:37,275
SPEAKERS UP.

1304
01:03:37,275 --> 01:03:39,844
WE HAVE PLENTY OF TIME FOR

1305
01:03:39,844 --> 01:03:47,585
QUESTIONS.

1306
01:03:47,585 --> 01:03:48,686
PLEASE REMEMBER TO USE THE

1307
01:03:48,686 --> 01:03:58,896
MICROPHONE.

1308
01:04:08,573 --> 01:04:19,016
>> I AM WITH THE FDA AND
ALSO

1309
01:04:25,857 --> 01:04:26,390
THE OFFICE OF VACCINE RESEARCH

1310
01:04:26,390 --> 01:04:26,691
AND REVIEW.

1311
01:04:26,691 --> 01:04:31,462
I HAVE A QUESTION YOU MENTIONED

1312
01:04:31,462 --> 01:04:35,633
THAT HUMAN MILK HAS A BIG IMPACT

1313
01:04:35,633 --> 01:04:38,236
ON THE INCIDENCE OF NEC FEEDING

1314
01:04:38,236 --> 01:04:42,607
EITHER MOTHERS OR DONOR MILK I

1315
01:04:42,607 --> 01:04:43,708
NOTICED THE DONOR MILK IS

1316
01:04:43,708 --> 01:04:46,878
PASTEURIZED.

1317
01:04:46,878 --> 01:04:49,013
IS THERE ANY DIFFERENCE BETWEEN

1318
01:04:49,013 --> 01:04:53,384
DONOR MELCHOR MOTHERS MILK?

1319
01:04:53,384 --> 01:05:01,292
>> MOTHERS MILK IS IDEAL

1320
01:05:01,292 --> 01:05:02,960
PASTEURIZATION DOES ALTER THE

1321
01:05:02,960 --> 01:05:06,030
CHARACTERISTICS LIKE THAT

1322
01:05:06,030 --> 01:05:10,668
MICROBES OR THE OTHER COMPONENTS

1323
01:05:10,668 --> 01:05:15,306
SOME ARE SUSTAINED SOUND YOU

1324
01:05:15,306 --> 01:05:18,342
LOOK AT THE BIOLOGIC DIFFERENCES

1325
01:05:18,342 --> 01:05:22,680
EFFECTIVE WITH PASTEURIZATION TO

1326
01:05:22,680 --> 01:05:23,247
REDUCE THE RISK OF INFECTION

1327
01:05:23,247 --> 01:05:28,553
THERE ARE SOME STUDIES SOMETIMES

1328
01:05:28,553 --> 01:05:29,086
THEY ARE OBSERVATIONAL AND

1329
01:05:29,086 --> 01:05:29,720
LIMITED THEY ARE CONFOUNDING BY

1330
01:05:29,720 --> 01:05:32,790
THOSE INDIVIDUALS THERE IS

1331
01:05:32,790 --> 01:05:36,060
PROVISION OF MOTHER ZONE MILK

1332
01:05:36,060 --> 01:05:40,064
THAT THEY MAY POTENTIALLY HAVE A

1333
01:05:40,064 --> 01:05:42,200
GREATER IMPACT OF MOTHER ZONE

1334
01:05:42,200 --> 01:05:48,873
MILK BUT THE TRIALS THAT YOU

1335
01:05:48,873 --> 01:05:49,774
JUST SHOWED HAVE A CLEAR AND

1336
01:05:49,774 --> 01:05:53,945
SIGNIFICANT EFFECT WHEN IT'S

1337
01:05:53,945 --> 01:05:56,247
LARGELY THE OWNER OF DIETS WITH

1338
01:05:56,247 --> 01:06:02,787
THE REDUCTION OF 50 PERCENT.

1339
01:06:02,787 --> 01:06:13,197
>> THAT IS MY QUESTION.

1340
01:06:17,969 --> 01:06:18,436
SO WITH THE PASTEURIZATION

1341
01:06:18,436 --> 01:06:22,340
PROCESS DOES THAT DEGRADE THE

1342
01:06:22,340 --> 01:06:25,576
ANTIBODIES THAT ARE TRANSMITTED

1343
01:06:25,576 --> 01:06:26,677
THROUGH COLOSTRUM?

1344
01:06:26,677 --> 01:06:34,285
>> AND WITH THE SPECIFIC

1345
01:06:34,285 --> 01:06:44,829
ANTIBODIES THERE IS SOME AFFECT.

1346
01:06:47,265 --> 01:06:47,632
>> IT DOES HOLD THE

1347
01:06:47,632 --> 01:06:48,199
PASTEURIZATION IT DOES NOT

1348
01:06:48,199 --> 01:06:58,676
ENTIRELY DEGRADE ANTIBODIES.

1349
01:06:59,477 --> 01:07:04,448
IT IS THE NON- SPECIFICITY SO

1350
01:07:04,448 --> 01:07:08,919
MOTHER'S OWN MILK PRESENTS THE

1351
01:07:08,919 --> 01:07:11,455
INFANT WITH ANTIBODIES DIRECTED

1352
01:07:11,455 --> 01:07:12,657
LARGELY TO THE MATERNAL

1353
01:07:12,657 --> 01:07:18,095
INFECTIOUS EXPERIENCE IDEALLY

1354
01:07:18,095 --> 01:07:20,331
MOTHER HAS TRANSMITTED THEIR OWN

1355
01:07:20,331 --> 01:07:25,336
MICRO BIOME AND SO THERE IS A

1356
01:07:25,336 --> 01:07:27,371
FIT BETWEEN THE ANTIBODY AND

1357
01:07:27,371 --> 01:07:30,474
MOTHER ZONE MILK.

1358
01:07:30,474 --> 01:07:38,482
1 COULD ARGUE DONOR MILK SO

1359
01:07:38,482 --> 01:07:40,151
THERE COULD BE WIDER EXPOSURE

1360
01:07:40,151 --> 01:07:44,488
AND LESS SPECIFIC AND DEPENDING

1361
01:07:44,488 --> 01:07:52,697
ON PREPARATION AND FREEZING

1362
01:07:52,697 --> 01:07:54,231
THERE COULD BE SOME DEGRADATION

1363
01:07:54,231 --> 01:08:03,240
OF ANTIBODY BUT NOT ENTIRELY.

1364
01:08:03,240 --> 01:08:11,315
>> A QUESTION IN THE CHAT.

1365
01:08:11,315 --> 01:08:14,585
MOST REQUIRE ALL ULTIMATE GROWTH

1366
01:08:14,585 --> 01:08:22,226
WITH BOVINE MILK.

1367
01:08:22,226 --> 01:08:28,232
>> .

1368
01:08:28,232 --> 01:08:30,735
>> THERE HAVE BEEN
CLINICAL

1369
01:08:30,735 --> 01:08:35,840
TRIALS BUT THE 2 MOST RECENT 1

1370
01:08:35,840 --> 01:08:38,609
THAT WAS PUBLISHED IN EUROPE AND

1371
01:08:38,609 --> 01:08:43,481
1 IN CANADA AS WELL AS THE

1372
01:08:43,481 --> 01:08:47,518
JENSEN CHILD THEY LOOKED AND

1373
01:08:47,518 --> 01:08:51,188
THEN COMPARED FORTIFICATION AND

1374
01:08:51,188 --> 01:08:51,789
THEN THERE IS A COMPARISON OF

1375
01:08:51,789 --> 01:08:53,391
BOVINE BASED fortification base 

1376
01:08:53,391 --> 01:09:00,698
based fortification Based fortin

1377
01:09:00,698 --> 01:09:01,298
WHICH WAS ON THE BASE SIDE OF

1378
01:09:01,298 --> 01:09:02,867
HUMAN MILK AND THOSE CLINICAL

1379
01:09:02,867 --> 01:09:04,935
TRIALS THERE WAS NO SIGNIFICANT

1380
01:09:04,935 --> 01:09:07,204
EFFECT ON EITHER TRIAL.

1381
01:09:07,204 --> 01:09:13,010
I DO THINK THERE ARE THOSE THAT

1382
01:09:13,010 --> 01:09:14,512
WILL TRY TO SYNTHESIZE BUT THEY

1383
01:09:14,512 --> 01:09:19,049
ARE STILL ONGOING.

1384
01:09:19,049 --> 01:09:21,619
SO TO RECEIVE HUMAN MILK AND THE

1385
01:09:21,619 --> 01:09:26,190
BENEFIT WITH THE ADDITIONAL

1386
01:09:26,190 --> 01:09:26,824
EFFECTIVE FORTIFICATION IS LESS

1387
01:09:26,824 --> 01:09:28,459
CERTAIN IN TERMS OF THE EFFECT

1388
01:09:28,459 --> 01:09:38,602
ON NEC.

1389
01:09:51,515 --> 01:09:52,082
>> I WORD ADD A COMMENT TO
DONOR

1390
01:09:52,082 --> 01:09:52,716
MILK IS MATURE MILK WE WOULD NOT

1391
01:09:52,716 --> 01:09:53,317
HAVE COLOSTRUM WHICH IS QUITE

1392
01:09:53,317 --> 01:09:53,951
DIFFERENT THAT WILL ALWAYS COME

1393
01:09:53,951 --> 01:09:54,585
FROM THE BABY'S MOTHER WE WOULD

1394
01:09:54,585 --> 01:09:55,219
NEVER HAVE COLOSTRUM AS A DONOR

1395
01:09:55,219 --> 01:09:55,820
PRODUCT AND HOW IMPORTANT THAT

1396
01:09:55,820 --> 01:09:56,454
IS I GUESS WE THINK IS IMPORTANT

1397
01:09:56,454 --> 01:09:56,887
BUT WE DON'T KNOW.

1398
01:09:56,887 --> 01:09:57,521
ALSO FOR DOCTOR KASLOW THE LINE

1399
01:09:57,521 --> 01:09:58,656
BETWEEN PROMOTING HEALTH AND

1400
01:09:58,656 --> 01:10:05,830
HEAT TO MITIGATE PREVENT AND

1401
01:10:05,830 --> 01:10:06,464
TREAT DISEASE IS MURKY WITH THIS

1402
01:10:06,464 --> 01:10:08,265
TOPIC 8 YOU DID NOT TOUCH ON A

1403
01:10:08,265 --> 01:10:10,968
SPECIFIC FROM A REGULATORY

1404
01:10:10,968 --> 01:10:11,602
STANDPOINT ALSO THOSE GENERALLY

1405
01:10:11,602 --> 01:10:13,804
REGARDED AS SAFE AND HOW DO YOU

1406
01:10:13,804 --> 01:10:20,444
THINK THIS TOPIC FITS IN THOSE 2

1407
01:10:20,444 --> 01:10:20,644
POOLS?

1408
01:10:20,644 --> 01:10:24,315
>> I THINK WE HAVE SOME

1409
01:10:24,315 --> 01:10:33,657
COLLEAGUES THAT CAN ADDRESS STAY

1410
01:10:33,657 --> 01:10:34,225
AWAY FROM THE FOOD SITE AND

1411
01:10:34,225 --> 01:10:34,792
FOCUS ON THE DRUGS WHICH IS

1412
01:10:34,792 --> 01:10:35,359
CLEARLY REGULATED AND I WENT

1413
01:10:35,359 --> 01:10:35,960
THROUGH WHAT THOSE REGULATIONS

1414
01:10:35,960 --> 01:10:37,061
ARE.

1415
01:10:37,061 --> 01:10:41,332
WE COULD POTENTIALLY BE WE

1416
01:10:41,332 --> 01:10:42,766
REALLY NEED TO PAY ATTENTION WHY

1417
01:10:42,766 --> 01:10:47,238
I HIGHLIGHTED PICO WHICH IS THE

1418
01:10:47,238 --> 01:10:48,672
POPULATION IN ADDITION TO THE

1419
01:10:48,672 --> 01:10:51,909
INTERVENTION AND THE OUTCOME.

1420
01:10:51,909 --> 01:10:56,113
WHAT WE ARE TALKING ABOUT I

1421
01:10:56,113 --> 01:11:03,020
THINK ARE UNHEALTHY INDIVIDUALS

1422
01:11:03,020 --> 01:11:03,587
AND I THINK WE LOOK AT THAT

1423
01:11:03,587 --> 01:11:04,221
DIFFERENTLY AND WE LOOK AT SOME

1424
01:11:04,221 --> 01:11:04,788
OF THESE FOODS OF OTHERWISE

1425
01:11:04,788 --> 01:11:07,258
HEALTHY INDIVIDUALS.

1426
01:11:07,258 --> 01:11:08,292
I DON'T KNOW IF ANYONE WANTS TO

1427
01:11:08,292 --> 01:11:11,929
COMMENT FURTHER.

1428
01:11:11,929 --> 01:11:12,496
I HAVE MY BRAIN TRUST IN THE

1429
01:11:12,496 --> 01:11:17,334
BACK ROW FROM THE OFFICE AS A

1430
01:11:17,334 --> 01:11:18,235
NEWLY MINTED DIRECTOR OF THE

1431
01:11:18,235 --> 01:11:19,737
OFFICE BUT I DON'T KNOW IF

1432
01:11:19,737 --> 01:11:21,238
ANYBODY ELSE WANTS TO CHIME IN

1433
01:11:21,238 --> 01:11:27,645
ON THAT?

1434
01:11:27,645 --> 01:11:31,048
>> I CAN COMMENT ON THE
FACT

1435
01:11:31,048 --> 01:11:32,283
FOOD IS SOMETHING THAT YOU TAKE

1436
01:11:32,283 --> 01:11:42,326
FOR NUTRITION, TASTE AND AROMA.

1437
01:11:42,326 --> 01:11:42,893
SO WHAT WE ARE TALKING ABOUT

1438
01:11:42,893 --> 01:11:43,827
HERE IS INTERVENTION TO PREVENT

1439
01:11:43,827 --> 01:11:48,599
THE DISEASE SO IT'S FROM WHAT IS

1440
01:11:48,599 --> 01:11:53,971
CONSIDERED TO BE A DRUG BUCKET

1441
01:11:53,971 --> 01:11:55,573
AND AS SUCH CONSIDERING THE

1442
01:11:55,573 --> 01:11:59,677
POPULATION I THINK IN THIS ROOM

1443
01:11:59,677 --> 01:12:02,046
WE WOULD ALL STRIVE TO HAVE A

1444
01:12:02,046 --> 01:12:05,649
PRODUCT THAT IS MANUFACTURED

1445
01:12:05,649 --> 01:12:07,184
ACCORDING TO PHARMACEUTICAL

1446
01:12:07,184 --> 01:12:11,221
GRADE AND ALSO HAS SHOWN TO BE

1447
01:12:11,221 --> 01:12:13,023
EFFECTIVE IN THIS VERY

1448
01:12:13,023 --> 01:12:23,400
VULNERABLE POPULATION.

1449
01:12:28,706 --> 01:12:33,310
>> CAN YOU OUTLINE THE
EFFECT OF

1450
01:12:33,310 --> 01:12:43,854
DIFFERENT SUPPLEMENTS AND OF THE

1451
01:12:45,923 --> 01:12:53,597
DIFFERENT SUPPLEMENTS?

1452
01:12:53,597 --> 01:12:56,867
>> BUT THEY ARE ALSO
MEDICATIONS

1453
01:12:56,867 --> 01:13:04,375
THERE HAS BEEN CONCERNED SOME

1454
01:13:04,375 --> 01:13:05,409
BABIES COULD BE SUBJECTED TO A

1455
01:13:05,409 --> 01:13:08,979
HIGHER RISK.

1456
01:13:08,979 --> 01:13:09,580
THERE'S NOT A GOOD DEED ABOUT

1457
01:13:09,580 --> 01:13:14,151
THE SPECIFICS BUT THAT HAS BEEN

1458
01:13:14,151 --> 01:13:17,955
THE CONCERN THAT COULD ALSO

1459
01:13:17,955 --> 01:13:19,356
RELATE TO INTRO FEEDING IN THE

1460
01:13:19,356 --> 01:13:26,096
CONCENTRATIONS AND TO HAVE

1461
01:13:26,096 --> 01:13:26,697
FORTIFIED FEEDINGS COULD BE IN

1462
01:13:26,697 --> 01:13:27,264
THE CONTRIBUTIONS OF HIGHLY

1463
01:13:27,264 --> 01:13:32,803
POSSIBLE NUTRITION DONOR.

1464
01:13:32,803 --> 01:13:40,110
>> THERE HAS BEEN
ATTENTION TO

1465
01:13:40,110 --> 01:13:40,678
THE TOPIC AND I DEFER TO THE

1466
01:13:40,678 --> 01:13:41,245
NUTRITIONIST IN THE NICU TO

1467
01:13:41,245 --> 01:13:45,349
ADVISE US ON THE DIFFERENTIAL

1468
01:13:45,349 --> 01:13:50,421
CONTRIBUTIONS OF SUPPLEMENTS AND

1469
01:13:50,421 --> 01:13:51,055
ADVANCEMENT OF FEEDING IT MAKES

1470
01:13:51,055 --> 01:13:53,023
A SIGNIFICANT DIFFERENCE WHEN IT

1471
01:13:53,023 --> 01:13:56,493
DOESN'T AND OVER TIME IT APPEARS

1472
01:13:56,493 --> 01:14:04,201
THE CHANGES ARE LESS THAN 20 OR

1473
01:14:04,201 --> 01:14:04,802
30 YEARS AGO AS PRODUCTS HAVE

1474
01:14:04,802 --> 01:14:09,173
BEEN REFINED IN DIFFERENT WAYS.

1475
01:14:09,173 --> 01:14:09,673
BUT I DO THINK WE NEED A

1476
01:14:09,673 --> 01:14:11,809
NUTRITION EXPERT TO QUANTIFY

1477
01:14:11,809 --> 01:14:18,615
THAT.

1478
01:14:18,615 --> 01:14:28,792
>> HELLO.

1479
01:14:33,597 --> 01:14:34,131
THIS IS A QUESTION FOR DOCTOR

1480
01:14:34,131 --> 01:14:34,364
KASLOW.

1481
01:14:34,364 --> 01:14:34,998
I APPRECIATE THE FRAMING OF THE

1482
01:14:34,998 --> 01:14:35,599
GOALS FOR TODAY AND IT SOUNDS

1483
01:14:35,599 --> 01:14:36,266
LIKE YOU ARE PUSHING TO IDENTIFY

1484
01:14:36,266 --> 01:14:38,335
THE RIGHT QUESTIONS AND STEPS

1485
01:14:38,335 --> 01:14:40,204
WITH THE APPROVAL PATHWAY THAT

1486
01:14:40,204 --> 01:14:44,274
YOU HAVE IN MIND BUT WITH THESE

1487
01:14:44,274 --> 01:14:46,944
PUBLIC WORKSHOPS AS AN IMMUNE NO

1488
01:14:46,944 --> 01:14:56,520
- - SO WHAT HAPPENS NEXT AFTER

1489
01:14:56,520 --> 01:14:56,720
TODAY?

1490
01:14:56,720 --> 01:14:57,321
AT THE END OF THE DAY WHAT IS

1491
01:14:57,321 --> 01:14:57,888
THE PATHWAY THAT MIGHT COMES

1492
01:14:57,888 --> 01:14:58,388
AFTER THIS WORKSHOP AND

1493
01:14:58,388 --> 01:15:01,792
DISCUSSIONS?

1494
01:15:01,792 --> 01:15:02,426
>> WE HAVE TO LEAVE THAT
TO THE

1495
01:15:02,426 --> 01:15:04,061
DEVELOPERS.

1496
01:15:04,061 --> 01:15:07,364
BUT OUR OFFICE IS WILLING READY

1497
01:15:07,364 --> 01:15:13,837
AND ABLE TO ACCEPT MISSIONS AND

1498
01:15:13,837 --> 01:15:14,471
REVIEWS OF INVESTIGATIONAL DRUG

1499
01:15:14,471 --> 01:15:16,673
APPLICATIONS THAT IDENTIFY THE

1500
01:15:16,673 --> 01:15:21,512
PATHWAY FOR DEMONSTRATING

1501
01:15:21,512 --> 01:15:22,012
SUBSTANTIAL EVIDENCE OF

1502
01:15:22,012 --> 01:15:28,819
EFFECTIVENESS BUT ALSO SAFETY

1503
01:15:28,819 --> 01:15:29,319
AND PRODUCT QUALITY.

1504
01:15:29,319 --> 01:15:29,920
I THINK THOSE ARE ALL SPELLED

1505
01:15:29,920 --> 01:15:31,588
OUT AND I TRIED TO PROVIDE

1506
01:15:31,588 --> 01:15:32,589
GUIDANCE DOCUMENTS TO DIRECT YOU

1507
01:15:32,589 --> 01:15:36,693
TO THAT.

1508
01:15:36,693 --> 01:15:37,261
BUT WE ARE WILLING READY AND

1509
01:15:37,261 --> 01:15:47,738
ABLE TO REVIEW SUBMISSIONS.

1510
01:15:52,976 --> 01:15:53,944
>> IN LOW AND MIDDLE
INCOME

1511
01:15:53,944 --> 01:15:59,917
COUNTRY WE USE IT WITH FORMULA

1512
01:15:59,917 --> 01:16:02,419
AND YOU HAVE ANY OPINION ON THAT

1513
01:16:02,419 --> 01:16:08,125
AFFECT?

1514
01:16:08,125 --> 01:16:12,029
>> I AM OUT OF LINE TO
COMMENT

1515
01:16:12,029 --> 01:16:14,264
ON THE UNIQUE CONTEXT AND

1516
01:16:14,264 --> 01:16:18,001
CIRCUMSTANCES THAT THE

1517
01:16:18,001 --> 01:16:19,002
CLINICIANS WOULD PRACTICE IN LOW

1518
01:16:19,002 --> 01:16:25,342
INCOME COUNTRIES.

1519
01:16:25,342 --> 01:16:30,848
>> OFTEN WE DO AND A
SPECIFIC

1520
01:16:30,848 --> 01:16:31,415
GESTATIONAL AGE AT BIRTH OR

1521
01:16:31,415 --> 01:16:33,417
CORRECTION DID -- -- CORRECTION

1522
01:16:33,417 --> 01:16:36,987
AGE WE ARE COUNSELED TO TRANSFER

1523
01:16:36,987 --> 01:16:39,489
TO FORTIFICATION WITH FORMULA

1524
01:16:39,489 --> 01:16:42,192
POWDER.

1525
01:16:42,192 --> 01:16:42,793
SO THERE IS A TIME IN US CARE

1526
01:16:42,793 --> 01:16:50,567
THAT IS ALSO PRACTICED.

1527
01:16:50,567 --> 01:16:51,168
I AGREE I HAVE NO EXPERTISE TO

1528
01:16:51,168 --> 01:16:53,103
COMMENT ON WHAT IS DONE IN OTHER

1529
01:16:53,103 --> 01:17:03,280
SETTINGS.

1530
01:17:06,083 --> 01:17:06,550
>> AS A CLINICIAN 1 OF THE

1531
01:17:06,550 --> 01:17:07,184
PROBLEMS THAT WE SEE WITH DONOR

1532
01:17:07,184 --> 01:17:09,853
MILK IS POOR GROWTH IN THE

1533
01:17:09,853 --> 01:17:12,222
REQUIREMENT WITH

1534
01:17:12,222 --> 01:17:12,589
SUPPLEMENTATION.

1535
01:17:12,589 --> 01:17:16,960
JUST COMING BACK TO SOMETHING I

1536
01:17:16,960 --> 01:17:26,036
HEARD THIS SUMMER WAS THERE IS

1537
01:17:26,036 --> 01:17:26,670
SOME EVIDENCE OF THE MATURATION

1538
01:17:26,670 --> 01:17:27,304
PROCESS OF THE MOTHER'S OWN MILK

1539
01:17:27,304 --> 01:17:27,971
WITH THE DEVELOPMENT OF THE BABY

1540
01:17:27,971 --> 01:17:30,674
AND WE HEARD THAT COMMENT HERE

1541
01:17:30,674 --> 01:17:33,844
THAT DONATED MILK TENDS TO MORE

1542
01:17:33,844 --> 01:17:36,647
MATURE?

1543
01:17:36,647 --> 01:17:42,119
>> ANY MILK TRIAL WHERE
BABIES

1544
01:17:42,119 --> 01:17:44,388
WERE RANDOMIZED THERE WAS

1545
01:17:44,388 --> 01:17:47,190
EVIDENCE LOWER WEIGHT GAIN

1546
01:17:47,190 --> 01:17:54,231
GROWTH COMPARED TO PRETERM

1547
01:17:54,231 --> 01:17:54,798
FORMULA SO THAT IS 1 OF THE

1548
01:17:54,798 --> 01:18:01,772
THINGS THAT HAS BEEN NOTED AND

1549
01:18:01,772 --> 01:18:02,339
HAS BEEN SHOWN AS MENTIONED

1550
01:18:02,339 --> 01:18:02,873
EARLIER MILK DONORS CAN BE

1551
01:18:02,873 --> 01:18:03,407
DIFFERENT IN TERMS OF

1552
01:18:03,407 --> 01:18:07,411
CHARACTERISTICS SOME MAY BE

1553
01:18:07,411 --> 01:18:08,312
DONATING AFTER THE BIRTH OF THE

1554
01:18:08,312 --> 01:18:11,748
TERM INFANT AND IT MAY BE MANY

1555
01:18:11,748 --> 01:18:18,855
MONTHS POSTPARTUM AND THAT TENDS

1556
01:18:18,855 --> 01:18:19,456
TO BE LOWER CALORIC DENSITY OR

1557
01:18:19,456 --> 01:18:19,790
LOWER PROTEIN.

1558
01:18:19,790 --> 01:18:24,127
A DONOR MAY HAVE DONATED CLOSER

1559
01:18:24,127 --> 01:18:25,629
TO POSTPARTUM OR AFTER PRETERM

1560
01:18:25,629 --> 01:18:35,205
DELIVERY WHERE CALORIC OR

1561
01:18:35,205 --> 01:18:35,806
PROTEIN INTAKE MAY BE HIGHER.

1562
01:18:35,806 --> 01:18:36,406
BUT SOME MILK BANKS ALLOW FOR

1563
01:18:36,406 --> 01:18:39,109
SELECTION OF PARTICULAR TYPES

1564
01:18:39,109 --> 01:18:39,910
THAT COULD HAVE DIFFERENCES IN

1565
01:18:39,910 --> 01:18:41,678
THE NUTRITIONAL CHARACTERISTICS.

1566
01:18:41,678 --> 01:18:47,884
THERE ARE GROUPS THAT USE THOSE

1567
01:18:47,884 --> 01:18:51,688
CALORIC CALORIES TO MEET TARG 

1568
01:18:51,688 --> 01:18:51,922
TARGETS.

1569
01:18:51,922 --> 01:18:54,024
EVEN THOUGH THE GROWTH OF THE

1570
01:18:54,024 --> 01:19:00,931
TRIAL THERE IS NO DIFFERENCE OF

1571
01:19:00,931 --> 01:19:01,565
LONG-TERM OUTCOME ALSO QUESTION

1572
01:19:01,565 --> 01:19:02,165
HOW CLINICALLY SIGNIFICANT IS

1573
01:19:02,165 --> 01:19:04,568
THE LOWER GROWTH THAT IS A

1574
01:19:04,568 --> 01:19:13,543
SIGNIFICANT DECREASE OF NEC.

1575
01:19:13,543 --> 01:19:14,144
>> THERE IS A RICH
DISCUSSION

1576
01:19:14,144 --> 01:19:14,978
GOING ON IN THE CHAT WITH

1577
01:19:14,978 --> 01:19:24,187
REFERENCES GIVEN.

1578
01:19:24,187 --> 01:19:24,688
>> THANK YOU FOR ALL THE

1579
01:19:24,688 --> 01:19:24,955
QUESTIONS.

1580
01:19:24,955 --> 01:19:25,822
WE DO WANT TO HAVE INTERACTION

1581
01:19:25,822 --> 01:19:28,158
WITH ONLINE PARTICIPANTS THIS IS

1582
01:19:28,158 --> 01:19:29,159
A GOOD EXAMPLE.

1583
01:19:29,159 --> 01:19:32,195
THANK YOU FOR ALL OF THE

1584
01:19:32,195 --> 01:19:40,237
SPEAKERS FROM THE FIRST SESSION

1585
01:19:40,237 --> 01:19:43,874
SO WE WILL TAKE A BREAK.

1586
01:19:43,874 --> 01:19:47,711
>> 1 ADDENDUM TO MY
RESPONSE AND

1587
01:19:47,711 --> 01:19:48,311
I THINK THIS IS SOMETHING THAT

1588
01:19:48,311 --> 01:19:51,448
CAN HAPPEN TOMORROW 1 OF THE

1589
01:19:51,448 --> 01:19:56,253
SLIDES I REVIEWED WAS THE FORMAL

1590
01:19:56,253 --> 01:19:56,787
COMMUNICATION AND MEETING

1591
01:19:56,787 --> 01:20:00,524
MECHANISM IN 1 PLACE TO START

1592
01:20:00,524 --> 01:20:01,124
WHAT REALLY GETS THE REGULATOR

1593
01:20:01,124 --> 01:20:04,795
MANUFACTURE ON THE SAME PAGE IS

1594
01:20:04,795 --> 01:20:07,330
WHERE THE DEVELOPER CAN SUBMIT

1595
01:20:07,330 --> 01:20:10,934
SOME SPECIFIC QUESTIONS TO THE

1596
01:20:10,934 --> 01:20:14,971
ISSUES OF CLINICAL STUDIES AND

1597
01:20:14,971 --> 01:20:16,440
GET A FORMAL RESPONSE BACK FROM

1598
01:20:16,440 --> 01:20:19,109
THE AGENCY.

1599
01:20:19,109 --> 01:20:25,048
I WOULD SAY TOMORROW THERE IS A

1600
01:20:25,048 --> 01:20:25,649
WHOLE MECHANISM FOR DOING THAT

1601
01:20:25,649 --> 01:20:26,283
AND I ENCOURAGE YOU TO READ THE

1602
01:20:26,283 --> 01:20:30,754
GUIDANCE DOCUMENT.

1603
01:20:30,754 --> 01:20:32,189
>> WE ARE BACK IN THIS
ROOM AND

1604
01:20:32,189 --> 01:20:32,622
10 MINUTES AT 1030.

1605
01:20:32,622 --> 01:20:38,801
THANK YOU.

1606
01:20:56,652 --> 01:20:57,152
OUR FIRST SPEAKER IS DOCTOR

1607
01:20:57,152 --> 01:20:57,753
JOSEPH NEU FROM THE UNIVERSITY

1608
01:20:57,753 --> 01:20:58,053
OF FLORIDA.

1609
01:20:58,053 --> 01:21:08,430
HE WILL GIVE US TO TALKS.

1610
01:21:08,430 --> 01:21:09,064
AND THE FIRST 1 IS ON CHALLENGES

1611
01:21:09,064 --> 01:21:09,531
WITH THE CURRENT CASE

1612
01:21:09,531 --> 01:21:13,435
DEFINITIONS FOR NEC.

1613
01:21:13,435 --> 01:21:15,304
THE STAGE IS YOURS.

1614
01:21:15,304 --> 01:21:25,781
>> I ALSO WANT TO THANK
THE

1615
01:21:31,453 --> 01:21:32,020
ORGANIZERS WERE PUTTING TOGETHER

1616
01:21:32,020 --> 01:21:32,587
THIS VERY IMPORTANT MEETING

1617
01:21:32,587 --> 01:21:36,091
THERE IS SO MUCH CONTROVERSY IN

1618
01:21:36,091 --> 01:21:37,225
THESE AREAS THAT JUST TO GET

1619
01:21:37,225 --> 01:21:38,994
TOGETHER TO TALK ABOUT IT.

1620
01:21:38,994 --> 01:21:42,564
IT'S A VERY IMPORTANT ASPECT.

1621
01:21:42,564 --> 01:21:46,335
SO LET ME START WITH A

1622
01:21:46,335 --> 01:21:49,304
DISCLOSURE AND I WORK WITH

1623
01:21:49,304 --> 01:21:52,374
INDUSTRY AND I HAVE SOME FUNDING

1624
01:21:52,374 --> 01:21:53,375
FROM NATIONAL INSTITUTES OF

1625
01:21:53,375 --> 01:22:02,651
HEALTH AND THE MAIN DISCLOSURE

1626
01:22:02,651 --> 01:22:03,852
AND TO HEAR MORE ABOUT THIS

1627
01:22:03,852 --> 01:22:12,994
LATER TODAY THE AREA THAT I WANT

1628
01:22:12,994 --> 01:22:13,562
TO TALK ABOUT STARTS HERE I

1629
01:22:13,562 --> 01:22:22,371
RECEIVED AN E-MAIL SO HE ASKED

1630
01:22:22,371 --> 01:22:28,543
ME IF I WAS AWARE OF THE RECENT

1631
01:22:28,543 --> 01:22:29,644
MEETING THAT THEY HAD AND NOW WE

1632
01:22:29,644 --> 01:22:32,981
HAVE THIS FANTASTIC OPPORTUNITY

1633
01:22:32,981 --> 01:22:36,251
TO DO MORE RESEARCH OF

1634
01:22:36,251 --> 01:22:40,522
NECROTIZING ENTEROCOLITIS.

1635
01:22:40,522 --> 01:22:42,791
AND RECOMMENDING STRATEGIES FOR

1636
01:22:42,791 --> 01:22:48,530
RESEARCH.

1637
01:22:48,530 --> 01:22:52,667
WITH THIS PREMATURE BABY AND

1638
01:22:52,667 --> 01:22:57,406
HERE IS THE WEBSITE AND I WAS

1639
01:22:57,406 --> 01:23:04,379
VERY EXCITED THAT IT WILL BE

1640
01:23:04,379 --> 01:23:14,923
FUNDING SOME WORK IN THIS AREA.

1641
01:23:16,525 --> 01:23:25,801
AND THERE IS A REASON FOR THAT.

1642
01:23:25,801 --> 01:23:26,401
AND THE REASON FOR THAT IS IF

1643
01:23:26,401 --> 01:23:27,035
YOU ARE DIGGING YOURSELF DEEPER

1644
01:23:27,035 --> 01:23:29,037
INTO A HOLE, FIRST THING YOU DO

1645
01:23:29,037 --> 01:23:37,512
IS PUT DOWN A SHOVEL.

1646
01:23:37,512 --> 01:23:38,480
WE HEARD THIS MORNING THAT

1647
01:23:38,480 --> 01:23:43,718
NUMEROUS STUDIES OF NECROTIZING

1648
01:23:43,718 --> 01:23:44,553
ENTEROCOLITIS.

1649
01:23:44,553 --> 01:23:48,123
THERE ARE FUZZY STUDIES THERE IS

1650
01:23:48,123 --> 01:23:58,066
A LOT OF ASSOCIATIONS WE DON'T

1651
01:23:58,066 --> 01:23:58,700
KNOW MUCH ABOUT THIS PROBLEM WE

1652
01:23:58,700 --> 01:24:01,736
CALL IT A DISEASE AND I QUESTION

1653
01:24:01,736 --> 01:24:09,144
IF THERE IS A DISTINCT DISEASE

1654
01:24:09,144 --> 01:24:09,744
WITH A QUIZ AND I WANT YOU TO

1655
01:24:09,744 --> 01:24:10,278
THINK ABOUT THIS AS WE GO

1656
01:24:10,278 --> 01:24:12,147
THROUGH.

1657
01:24:12,147 --> 01:24:15,183
PLEASE DEFINE NECROTIZING

1658
01:24:15,183 --> 01:24:18,119
ENTEROCOLITIS.

1659
01:24:18,119 --> 01:24:20,589
2 YEARS AGO I WAS ON THE PHD

1660
01:24:20,589 --> 01:24:30,765
COMMITTEE.

1661
01:24:31,800 --> 01:24:35,170
SO PLEASE DEFINE NECROTIZING

1662
01:24:35,170 --> 01:24:45,447
ENTEROCOLITIS AND G.I.

1663
01:24:45,447 --> 01:24:55,657
DEVELOPMENT.

1664
01:24:59,961 --> 01:25:02,063
DO BABIES WITH BELLS STAGE 1 OR

1665
01:25:02,063 --> 01:25:08,169
2 NEC HAVE INTESTINAL NECROSIS?

1666
01:25:08,169 --> 01:25:08,803
IF THEY DON'T AND WE ARE CALLING

1667
01:25:08,803 --> 01:25:09,371
IT NECROTIZING ENTEROCOLITIS

1668
01:25:09,371 --> 01:25:13,942
ISN'T THAT A MISNOMER?

1669
01:25:13,942 --> 01:25:14,576
DO WE HAVE A CLEAR UNDERSTANDING

1670
01:25:14,576 --> 01:25:18,980
OF THE PATH OF PHYSIOLOGY -- --

1671
01:25:18,980 --> 01:25:22,150
PATHOPHYSIOLOGY?

1672
01:25:22,150 --> 01:25:25,020
DO WE HAVE ACCURATE BIOMARKERS

1673
01:25:25,020 --> 01:25:35,163
FOR NEC?

1674
01:25:36,164 --> 01:25:37,966
ARE THERE PREVENTATIVE

1675
01:25:37,966 --> 01:25:48,410
STRATEGIES AND WITH THESE

1676
01:25:49,277 --> 01:25:49,844
DYSFUNCTIONS THAT WE ARE CALLING

1677
01:25:49,844 --> 01:25:50,478
THEM AND I WILL MAKE A CASE FOR

1678
01:25:50,478 --> 01:25:56,251
THIS.

1679
01:25:56,251 --> 01:25:56,851
IN 1965, ALEXANDER SCHAEFER

1680
01:25:56,851 --> 01:25:59,688
DISEASES OF THE NEWBORN.

1681
01:25:59,688 --> 01:26:01,990
IT WAS WRITTEN IN THE BOOK ABOUT

1682
01:26:01,990 --> 01:26:06,561
NEC.

1683
01:26:06,561 --> 01:26:08,997
NOTHING WAS WRITTEN AND THEN 6

1684
01:26:08,997 --> 01:26:10,799
YEARS LATER DISEASE OF THE

1685
01:26:10,799 --> 01:26:16,171
NEWBORN A FEW SENTENCES MAY BE

1686
01:26:16,171 --> 01:26:20,075
THE PARAGRAPH OF NECROTIZING

1687
01:26:20,075 --> 01:26:25,046
ENTEROCOLITIS.

1688
01:26:25,046 --> 01:26:26,281
AND TO RECOGNIZE THERE WAS

1689
01:26:26,281 --> 01:26:29,417
SOMETHING THEY ARE CALLING

1690
01:26:29,417 --> 01:26:39,861
NECROTIZING ENTEROCOLITIS.

1691
01:26:46,901 --> 01:26:47,435
AND THEN THE BABY GETS BETTER

1692
01:26:47,435 --> 01:26:48,069
AFTER A COUPLE OF WEEKS AND THEN

1693
01:26:48,069 --> 01:26:54,542
SUDDENLY DEVELOPS OR A DISTENDED

1694
01:26:54,542 --> 01:26:55,176
ABDOMEN AND GOES TO SURGERY THE

1695
01:26:55,176 --> 01:26:55,777
ENTIRE BOWEL IS DEAD AND THE

1696
01:26:55,777 --> 01:26:56,044
BABY DIES.

1697
01:26:56,044 --> 01:27:04,285
THIS IS DEVASTATING AS YOU SAW

1698
01:27:04,285 --> 01:27:14,129
IN PREVIOUS LECTURES THEY DIED.

1699
01:27:14,129 --> 01:27:14,663
IT IS A TERRIBLE PROBLEM.

1700
01:27:14,663 --> 01:27:15,296
BUT AS YOU ALSO SAW FOR THE LAST

1701
01:27:15,296 --> 01:27:15,897
60 YEARS WE HAVE NOT HAD VERY

1702
01:27:15,897 --> 01:27:20,135
MUCH PROGRESS.

1703
01:27:20,135 --> 01:27:20,735
THERE ARE SEVERAL REASONS FOR

1704
01:27:20,735 --> 01:27:20,935
THIS.

1705
01:27:20,935 --> 01:27:26,474
AND HERE IS 1 OF THEM.

1706
01:27:26,474 --> 01:27:27,108
AND CALLING THIS INTO THE SAME

1707
01:27:27,108 --> 01:27:31,680
DATA SET.

1708
01:27:31,680 --> 01:27:34,449
WE HAVE ANIMAL MODELS THAT DO

1709
01:27:34,449 --> 01:27:43,024
NOT CORRECTLY REPRESENT WITH THE

1710
01:27:43,024 --> 01:27:44,059
INDIVIDUAL PATHWAYS RATHER THAN

1711
01:27:44,059 --> 01:27:50,065
SYSTEMS.

1712
01:27:50,065 --> 01:27:53,068
AND IN 2011 DOCTOR WALKER AND I

1713
01:27:53,068 --> 01:27:58,206
WROTE AN ARTICLE ON NECROTIZING

1714
01:27:58,206 --> 01:28:08,450
ENTEROCOLITIS.

1715
01:28:20,161 --> 01:28:20,662
AND THAT THERE WERE PROBABLY

1716
01:28:20,662 --> 01:28:21,262
SEVERAL ENTITIES THAT WE WERE

1717
01:28:21,262 --> 01:28:21,696
CALLING NECROTIZING

1718
01:28:21,696 --> 01:28:22,297
ENTEROCOLITIS AND AT THAT TIME

1719
01:28:22,297 --> 01:28:22,931
BEGINNING TO RECOGNIZE SPUN TIME

1720
01:28:22,931 --> 01:28:23,565
-- -- SPONTANEOUS PROLIFERATION

1721
01:28:23,565 --> 01:28:24,933
IS SOMETHING WE WERE CALLING

1722
01:28:24,933 --> 01:28:25,567
NECROTIZING ENTEROCOLITIS BUT IT

1723
01:28:25,567 --> 01:28:29,170
WAS A DIFFERENT ENTITY.

1724
01:28:29,170 --> 01:28:29,771
AND THERE WAS SUGGESTIONS THAT

1725
01:28:29,771 --> 01:28:31,806
THERE WERE SEVERAL DIFFERENT

1726
01:28:31,806 --> 01:28:33,108
ENTITIES THAT WE WERE CALLING

1727
01:28:33,108 --> 01:28:42,450
NECROTIZING ENTEROCOLITIS.

1728
01:28:42,450 --> 01:28:45,987
WITH THE PREMATURE BABY WITH A

1729
01:28:45,987 --> 01:28:54,562
DISTENDED ABDOMEN.

1730
01:28:54,562 --> 01:28:55,196
SO THIS BABY GOT WORSE WENT TO

1731
01:28:55,196 --> 01:29:01,269
THE OPERATING ROOM AND HAD PIECE

1732
01:29:01,269 --> 01:29:01,736
OF NECROTIC INTESTINE.

1733
01:29:01,736 --> 01:29:03,438
THAT IS WHAT WE WERE CONSIDERING

1734
01:29:03,438 --> 01:29:04,506
CLASSIC NECROTIZING

1735
01:29:04,506 --> 01:29:06,407
ENTEROCOLITIS.

1736
01:29:06,407 --> 01:29:10,278
SO NOW IN 2024.

1737
01:29:10,278 --> 01:29:15,316
TO HAVE A CLASSIC NECROTIZING

1738
01:29:15,316 --> 01:29:15,650
ENTEROCOLITIS.

1739
01:29:15,650 --> 01:29:20,722
THE SAME REVIEW ARTICLE WE

1740
01:29:20,722 --> 01:29:22,557
THOUGHT THERE WAS A CERTAIN PATH

1741
01:29:22,557 --> 01:29:26,194
OF PHYSIOLOGY THAT WAS COMMON IN

1742
01:29:26,194 --> 01:29:27,996
BABIES WITH NECROTIZING

1743
01:29:27,996 --> 01:29:28,329
ENTEROCOLITIS.

1744
01:29:28,329 --> 01:29:31,599
AND HERE IS A PICTURE THAT WE

1745
01:29:31,599 --> 01:29:33,067
SHOWED ON THE ARTICLE WITH A

1746
01:29:33,067 --> 01:29:36,104
COMBINATION OF

1747
01:29:36,104 --> 01:29:36,905
PREMATURITY, GENETIC

1748
01:29:36,905 --> 01:29:43,978
PREDISPOSITION.

1749
01:29:43,978 --> 01:29:44,546
AND CAUSES THE INFLAMMATORY

1750
01:29:44,546 --> 01:29:46,681
RESPONSE AND THAT ENDS UP BEING

1751
01:29:46,681 --> 01:29:52,520
NECROSIS.

1752
01:29:52,520 --> 01:29:53,988
IT'S THE ONLY POTENTIAL PATHWAY

1753
01:29:53,988 --> 01:29:55,456
AS WELL.

1754
01:29:55,456 --> 01:29:59,360
AND IT WAS RECOGNIZED IN THE

1755
01:29:59,360 --> 01:30:06,301
1970S FIRST WE HAVE TO LEARN

1756
01:30:06,301 --> 01:30:08,069
ABOUT HYPOXIA ISCHEMIA.

1757
01:30:08,069 --> 01:30:10,638
WE WERE CONVINCED IN THE

1758
01:30:10,638 --> 01:30:14,375
SEVENTIES THAT NECROTIZING

1759
01:30:14,375 --> 01:30:16,177
ENTEROCOLITIS THIS MODEL WAS

1760
01:30:16,177 --> 01:30:18,780
DEVELOPED THIS IS AN UNDER -- --

1761
01:30:18,780 --> 01:30:28,389
AN ANIMAL MODEL THAT RELIES ON

1762
01:30:28,389 --> 01:30:28,857
AND HYPOXIA ISCHEMIA.

1763
01:30:28,857 --> 01:30:29,490
THEY PUT THEM IN THE PLASTIC BAG

1764
01:30:29,490 --> 01:30:33,494
AND CLOSE IT UP FOR 7 OR 8

1765
01:30:33,494 --> 01:30:37,799
MINUTES THEY TURN BLUE AND GAS

1766
01:30:37,799 --> 01:30:38,099
-- -- GASP.

1767
01:30:38,099 --> 01:30:38,933
THEN YOU PUT THEM INTO A

1768
01:30:38,933 --> 01:30:44,572
REFRIGERATOR.

1769
01:30:44,572 --> 01:30:45,874
AND THEN YOU TAKE THEM OUT OF

1770
01:30:45,874 --> 01:30:47,809
THE REFRIGERATOR THEN FEED THEM

1771
01:30:47,809 --> 01:30:53,181
SOMETHING TOTALLY DIFFERENT BUT

1772
01:30:53,181 --> 01:30:59,287
THEN THE BABY ANIMALS FOR A FEW

1773
01:30:59,287 --> 01:31:09,230
DAYS.

1774
01:31:09,230 --> 01:31:17,272
AND THERE ARE OVER 200 PAPERS

1775
01:31:17,272 --> 01:31:18,373
SHOWING THIS MODEL IS CALLED A

1776
01:31:18,373 --> 01:31:20,675
MODEL OF NECROTIZING

1777
01:31:20,675 --> 01:31:22,210
ENTEROCOLITIS.

1778
01:31:22,210 --> 01:31:31,619
IS THIS REALLY A GOOD MODEL?

1779
01:31:31,619 --> 01:31:32,287
BUT IS IT A MODEL OF WHAT WE SEE

1780
01:31:32,287 --> 01:31:42,530
IN THE BABIES?

1781
01:31:45,500 --> 01:31:51,606
AND THIS OCCURS BETWEEN 28

1782
01:31:51,606 --> 01:31:52,206
THROUGH 31 WEEKS OF CORRECTED

1783
01:31:52,206 --> 01:31:52,840
GESTATIONAL AGE WHERE WE SEE THE

1784
01:31:52,840 --> 01:32:00,882
PEAK.

1785
01:32:00,882 --> 01:32:09,590
IF THEY HAD SEVERE HYPOXIA AT

1786
01:32:09,590 --> 01:32:10,525
BIRTH WE WOULD SEE A LOT OF

1787
01:32:10,525 --> 01:32:12,894
BABIES WITH LOW APGAR SCORES

1788
01:32:12,894 --> 01:32:13,361
DEVELOPING NECROTIZING

1789
01:32:13,361 --> 01:32:13,995
ENTEROCOLITIS AFTER BIRTH BUT

1790
01:32:13,995 --> 01:32:16,698
THAT'S NOT WHAT WE ARE SEEING.

1791
01:32:16,698 --> 01:32:19,567
SO WHAT HAPPENS DURING THIS

1792
01:32:19,567 --> 01:32:26,474
PERIOD OF TIME?

1793
01:32:26,474 --> 01:32:29,010
NOT WITH RETINOPATHY PRIOR TO

1794
01:32:29,010 --> 01:32:30,311
MATURITY SO THERE IS

1795
01:32:30,311 --> 01:32:39,754
MICROVASCULAR CHANGES GOING ON

1796
01:32:39,754 --> 01:32:40,321
THAT THE BARRIER IS STILL

1797
01:32:40,321 --> 01:32:40,855
IMMATURE AT THIS TIME AND

1798
01:32:40,855 --> 01:32:48,863
DEVELOPMENTAL PATTERN CHANGES

1799
01:32:48,863 --> 01:32:51,432
THAT IN THE MID- SECOND

1800
01:32:51,432 --> 01:32:57,305
TRIMESTER THE RECEPTORS ARE AT

1801
01:32:57,305 --> 01:32:57,905
THEIR HIGHEST DENSITY AND THIS

1802
01:32:57,905 --> 01:32:58,539
IS WHEN YOU HAVE THE EXPOSURE TO

1803
01:32:58,539 --> 01:33:03,978
MICROBES.

1804
01:33:03,978 --> 01:33:04,612
THIS SETS UP THE PERFECT STORM

1805
01:33:04,612 --> 01:33:11,919
FOR INFLAMMATORY'S.

1806
01:33:11,919 --> 01:33:12,587
WE ARE NOT SURE THIS IS WHAT IS

1807
01:33:12,587 --> 01:33:23,031
GOING ON WITH ALL BABIES.

1808
01:33:27,135 --> 01:33:28,136
SO WE WROTE THIS ARTICLES

1809
01:33:28,136 --> 01:33:36,310
PUBLISHED IN 2017.

1810
01:33:36,310 --> 01:33:36,811
AND TAKING THE DATA FROM

1811
01:33:36,811 --> 01:33:42,884
NEONATAL INTENSIVE CARE UNITS.

1812
01:33:42,884 --> 01:33:47,722
AND THEN TO GET DATA TO PUT THIS

1813
01:33:47,722 --> 01:33:58,366
TOGETHER AT BAYLOR UNIVERSITY.

1814
01:33:58,366 --> 01:33:59,534
AND THE DATA FROM THE MICROBIAL

1815
01:33:59,534 --> 01:34:03,337
DNA.

1816
01:34:03,337 --> 01:34:03,938
HERE WHAT WE ARE SEEING ON THE

1817
01:34:03,938 --> 01:34:08,676
LEFT SIDE OF THE SLIDE IS

1818
01:34:08,676 --> 01:34:09,710
BETWEEN 24 AND 36 WEEKS

1819
01:34:09,710 --> 01:34:11,312
GESTATION AND WE SEE RELATIVE

1820
01:34:11,312 --> 01:34:14,949
ABUNDANCE OF MICROBES.

1821
01:34:14,949 --> 01:34:15,550
WHEN WE LOOK AT THE RIGHT SIDE

1822
01:34:15,550 --> 01:34:21,055
WE SEE DIFFERENCES IN THE COLORS

1823
01:34:21,055 --> 01:34:21,689
WHAT ARE THE DIFFERENCES WE ARE

1824
01:34:21,689 --> 01:34:23,658
SEEING AND THE BABIES THAT WE

1825
01:34:23,658 --> 01:34:25,193
DEVELOP COMPARED TO THE CONTROL

1826
01:34:25,193 --> 01:34:25,426
BABIES?

1827
01:34:25,426 --> 01:34:28,296
WE SEE AN INCREASE OF PRO- DEAL

1828
01:34:28,296 --> 01:34:37,472
BACTERIA OVER TIME AND ALMOST

1829
01:34:37,472 --> 01:34:44,078
WHAT DOES THIS MEAN IT HAS A LOT

1830
01:34:44,078 --> 01:34:54,522
OF LBS IN THEIR CELL WALL.

1831
01:35:00,595 --> 01:35:01,162
AND THEY ARE DECREASING OF THE

1832
01:35:01,162 --> 01:35:02,296
MORE POSITIVE MICROBES TO HAVE A

1833
01:35:02,296 --> 01:35:09,604
BIOREACTOR THAT THEY PRODUCE

1834
01:35:09,604 --> 01:35:10,138
FATTY ACID SOME ARE WHICH

1835
01:35:10,138 --> 01:35:11,739
THOUGHT TO BE VERY IMPORTANT

1836
01:35:11,739 --> 01:35:19,147
WITH INTEGRITY.

1837
01:35:19,147 --> 01:35:21,249
AND WITH THESE COMPONENTS THAT

1838
01:35:21,249 --> 01:35:26,154
STIMULATE THE CELLS TO HELP AND

1839
01:35:26,154 --> 01:35:30,925
DIFFERENTIATE THE T CELLS INTO T

1840
01:35:30,925 --> 01:35:35,429
CELLS AND THIS PARTICULAR

1841
01:35:35,429 --> 01:35:37,665
BACTERIA DIFFERENTIATES INTO

1842
01:35:37,665 --> 01:35:40,668
COLONIZING T CELLS BUT WE SEE

1843
01:35:40,668 --> 01:35:45,706
THE DECREASE SO THIS IS A VERY

1844
01:35:45,706 --> 01:35:46,307
INTERESTING ASSOCIATION BUT IT

1845
01:35:46,307 --> 01:35:47,742
DOESN'T TELL US CAUSALITY JUST

1846
01:35:47,742 --> 01:35:50,044
LIKE SEVERAL OF THE OTHER

1847
01:35:50,044 --> 01:35:52,180
STUDIES.

1848
01:35:52,180 --> 01:36:02,690
WE HAVE A LOT OF ASSOCIATIONS.

1849
01:36:03,758 --> 01:36:09,063
IT IS A GUMBALL MACHINE.

1850
01:36:09,063 --> 01:36:10,531
WE ARE SEEING DIFFERENT

1851
01:36:10,531 --> 01:36:11,799
GUMBALLS, COLORS AND FLAVORS.

1852
01:36:11,799 --> 01:36:18,272
HERE IS THE ANALOGY.

1853
01:36:18,272 --> 01:36:20,808
BECAUSE IT IS SO MANY DIFFERENT

1854
01:36:20,808 --> 01:36:25,179
PROBLEMS WE HAVE A DIMINISH OF

1855
01:36:25,179 --> 01:36:25,980
PROBLEMS AND THAT IS 1 OF THE

1856
01:36:25,980 --> 01:36:30,318
MAJOR PROBLEMS THAT WE HAVE TO

1857
01:36:30,318 --> 01:36:35,189
SAY THIS PARTICULAR AGENT

1858
01:36:35,189 --> 01:36:37,758
PREVENTED NECROTIZING

1859
01:36:37,758 --> 01:36:40,294
ENTEROCOLITIS WITH CURRENT

1860
01:36:40,294 --> 01:36:44,432
DIFFICULTIES AND OPPORTUNITIES.

1861
01:36:44,432 --> 01:36:48,703
THESE 8 DIFFERENT DEFINITIONS DO

1862
01:36:48,703 --> 01:36:50,238
WE HAVE A DEFINITION?

1863
01:36:50,238 --> 01:36:56,911
I DON'T THINK SO.

1864
01:36:56,911 --> 01:36:57,578
HERE ARE SOME OF THE PROBLEMS WE

1865
01:36:57,578 --> 01:37:06,887
ARE CALLING NET.

1866
01:37:06,887 --> 01:37:15,529
THIS IS A STAGING CRITERIA IN

1867
01:37:15,529 --> 01:37:16,163
THE LATE SEVENTIES IN KANSAS AND

1868
01:37:16,163 --> 01:37:22,103
THIS WAS NOT MEANT TO DEFINE

1869
01:37:22,103 --> 01:37:22,737
NECROTIZING ENTEROCOLITIS BUT TO

1870
01:37:22,737 --> 01:37:24,939
GIVE SOME IDEA WHAT IS GOING ON

1871
01:37:24,939 --> 01:37:28,743
WITH THE DEGREE OF ILLNESS AND

1872
01:37:28,743 --> 01:37:33,514
STAGE I 2024 IS TOTALLY

1873
01:37:33,514 --> 01:37:38,252
MEANINGLESS ALMOST ALL OF THE

1874
01:37:38,252 --> 01:37:44,358
TINY BABIES HAVE SOME DISTENTION

1875
01:37:44,358 --> 01:37:44,925
AND SOME INSTABILITIES.

1876
01:37:44,925 --> 01:37:47,995
THAT WOULD ALL BE CONSIDERED

1877
01:37:47,995 --> 01:37:50,731
STAGE I ADVERTISING.

1878
01:37:50,731 --> 01:37:53,668
STAGE II.

1879
01:37:53,668 --> 01:37:56,937
USUALLY RADIOGRAPHIC EVIDENCE

1880
01:37:56,937 --> 01:38:02,777
HELPS WITH STAGE II AND I WILL

1881
01:38:02,777 --> 01:38:03,844
GIVE YOU STAGE II INFORMATION

1882
01:38:03,844 --> 01:38:06,681
SHORTLY WITH -- -- INTESTINAL

1883
01:38:06,681 --> 01:38:09,150
PREPARATIONS I THINK NOW WE ARE

1884
01:38:09,150 --> 01:38:10,351
CONVINCED THAT IS A DIFFERENT

1885
01:38:10,351 --> 01:38:14,188
DISEASE ENTITY AND NEC BUT

1886
01:38:14,188 --> 01:38:19,327
HIGHLY PROBLEMATIC IS THAT WHERE

1887
01:38:19,327 --> 01:38:20,895
THE BABIES DEVELOP THE PROBLEM

1888
01:38:20,895 --> 01:38:24,098
SURGEONS PUT IN THE DRAIN AND WE

1889
01:38:24,098 --> 01:38:30,905
DON'T HAVE A GOOD CODE FOR

1890
01:38:30,905 --> 01:38:31,505
SPONTANEOUS INTENTIONAL -- --

1891
01:38:31,505 --> 01:38:32,139
INTESTINAL PREPARATIONS WAS PUT

1892
01:38:32,139 --> 01:38:36,043
INTO THE MEDICAL RECORDS IS NEC.

1893
01:38:36,043 --> 01:38:39,080
SO THAT TELLS US THE MEDICAL

1894
01:38:39,080 --> 01:38:47,955
RECORDS ARE NOT THAT HELPFUL AND

1895
01:38:47,955 --> 01:38:48,589
IN FACT IF YOU HAVE THESE IN THE

1896
01:38:48,589 --> 01:38:49,390
MEDICAL RECORDS THIS IS HIGHLY

1897
01:38:49,390 --> 01:38:53,027
PROBLEMATIC BABIES WITH

1898
01:38:53,027 --> 01:38:56,564
CARDIOGENIC ISCHEMIA.

1899
01:38:56,564 --> 01:38:59,033
THOSE HAVE INTERRUPTED AORTIC

1900
01:38:59,033 --> 01:39:02,203
ARCH THAT IS A TOTALLY DIFFERENT

1901
01:39:02,203 --> 01:39:04,205
PROBLEM.

1902
01:39:04,205 --> 01:39:10,711
SO JUST TO GIVE YOU SOME IDEA WE

1903
01:39:10,711 --> 01:39:11,345
HAVE THIS CONDITION OF PROBLEMS

1904
01:39:11,345 --> 01:39:11,912
THAT WE ARE ALL CALLING NEC.

1905
01:39:11,912 --> 01:39:15,082
HERE IS AN INTERESTING EXAMPLE

1906
01:39:15,082 --> 01:39:15,683
THIS IS AN X-RAY TAKEN OF THE

1907
01:39:15,683 --> 01:39:23,724
BABY WHO ACTUALLY HAD NO REAL

1908
01:39:23,724 --> 01:39:24,325
CONSIDERATIONS OF ANYTHING IN

1909
01:39:24,325 --> 01:39:24,692
THE G.I. TRACT.

1910
01:39:24,692 --> 01:39:27,428
THE RADIOLOGIST SAID THERE IS

1911
01:39:27,428 --> 01:39:30,898
SOMETHING IN THIS WRITE UP AND I

1912
01:39:30,898 --> 01:39:36,871
DON'T REALLY KNOW WHAT THIS IS

1913
01:39:36,871 --> 01:39:42,476
IT COULD BE IT COULD BE STAGE TO

1914
01:39:42,476 --> 01:39:47,815
NEC.

1915
01:39:47,815 --> 01:39:58,359
NORMAL PHYSICAL EXAMINATION THIS

1916
01:40:02,463 --> 01:40:02,897
IS JUST TOO WILL IN THE

1917
01:40:02,897 --> 01:40:03,798
GASTROINTESTINAL TRACT WE SEE

1918
01:40:03,798 --> 01:40:12,807
THIS VERY OFTEN AND HAS BEEN

1919
01:40:12,807 --> 01:40:13,441
RECORDED IN THE CHART AS HAVING

1920
01:40:13,441 --> 01:40:14,008
NEC AND MANY OF THESE BABIES

1921
01:40:14,008 --> 01:40:14,875
ALSO HAVE 7 DAYS OF ANTIBIOTICS

1922
01:40:14,875 --> 01:40:19,613
AND ARE PLACED IN PO AND IT IS

1923
01:40:19,613 --> 01:40:25,252
HIGHLY PROBLEMATIC.

1924
01:40:25,252 --> 01:40:35,729
HERE WE HAVE ANOTHER BABY

1925
01:40:35,729 --> 01:40:36,464
OUTSIDE OF THE BOWEL WALL AND

1926
01:40:36,464 --> 01:40:37,531
THE BABY WENT TO SURGERY AND

1927
01:40:37,531 --> 01:40:39,667
THIS IS WHAT THEY SAW.

1928
01:40:39,667 --> 01:40:44,004
A SMALL PERFORATION.

1929
01:40:44,004 --> 01:40:46,340
NECROSIS.

1930
01:40:46,340 --> 01:40:50,010
THIS IS CALLED SPONTANEOUS

1931
01:40:50,010 --> 01:40:56,917
PERFORATION THIS IS NOT

1932
01:40:56,917 --> 01:40:57,518
NECROTIZING ENTEROCOLITIS BUT

1933
01:40:57,518 --> 01:40:58,118
AGAIN MANY OF THESE BABIES ARE

1934
01:40:58,118 --> 01:40:59,253
CODED IN THEIR CHART AS HAVING

1935
01:40:59,253 --> 01:41:09,330
NEC.

1936
01:41:09,597 --> 01:41:10,164
A FRIEND WROTE THIS COMMENTARY A

1937
01:41:10,164 --> 01:41:10,698
COUPLE OF YEARS AGO THE

1938
01:41:10,698 --> 01:41:13,801
DEFINITIONS OF NEC.

1939
01:41:13,801 --> 01:41:19,540
WHAT ARE WE DEFINING AND HIS

1940
01:41:19,540 --> 01:41:20,107
MACHINE LEARNING THE ANSWER?

1941
01:41:20,107 --> 01:41:20,708
IT'S INTERESTING THIS ARTICLE

1942
01:41:20,708 --> 01:41:24,011
CAME OUT ABOUT THE SAME TIME WE

1943
01:41:24,011 --> 01:41:24,578
WERE DOING SOME YOU GET THE

1944
01:41:24,578 --> 01:41:25,479
UNIVERSITY OF FLORIDA TRYING TO

1945
01:41:25,479 --> 01:41:30,050
DIFFERENTIATE BEING ABLE TO USE

1946
01:41:30,050 --> 01:41:31,552
SOME EARLY FEATURES TO

1947
01:41:31,552 --> 01:41:36,790
DIFFERENTIATE SPONTANEOUS

1948
01:41:36,790 --> 01:41:38,158
PERFORATION FROM NECROSIS OF THE

1949
01:41:38,158 --> 01:41:41,028
BOWEL PERK WE HAVE THIS PICTURE

1950
01:41:41,028 --> 01:41:43,497
FROM BEFORE AND HERE IS

1951
01:41:43,497 --> 01:41:47,268
NECROTIZING ENTEROCOLITIS.

1952
01:41:47,268 --> 01:41:47,868
WE HAD BABIES IN OUR DATA SET

1953
01:41:47,868 --> 01:41:48,402
THAT ACTUALLY WENT TO THE

1954
01:41:48,402 --> 01:41:51,672
OPERATING ROOM WHERE THEY SAW IT

1955
01:41:51,672 --> 01:41:54,475
EITHER TRUE NECROSIS OF THE

1956
01:41:54,475 --> 01:42:03,017
INTESTINE OR INSTANTANEOUS

1957
01:42:03,017 --> 01:42:03,651
PERFORATION AND WE USE TO REVISE

1958
01:42:03,651 --> 01:42:04,251
MACHINE LEARNING TO SEE IF WE

1959
01:42:04,251 --> 01:42:04,885
COULD DIFFERENTIATE BETWEEN THE

1960
01:42:04,885 --> 01:42:06,487
2 BEFORE THE EVEN HAPPENED.

1961
01:42:06,487 --> 01:42:07,888
THERE WERE 2 DIFFERENT

1962
01:42:07,888 --> 01:42:17,831
ALGORITHMS THAT WERE USED AND

1963
01:42:17,831 --> 01:42:18,399
UNDER THE CURVE AND HERE ARE

1964
01:42:18,399 --> 01:42:20,668
SOME OF THE FEATURES THAT WERE

1965
01:42:20,668 --> 01:42:24,104
HIGHLY RELATED TO TELL THE

1966
01:42:24,104 --> 01:42:25,272
DIFFERENCE BETWEEN THE 2.

1967
01:42:25,272 --> 01:42:32,112
AND A MAJOR INTEREST IS THE

1968
01:42:32,112 --> 01:42:32,646
INSTANTANEOUS PERFORATIONS

1969
01:42:32,646 --> 01:42:33,280
OCCURRED VERY EARLY IN THE MOST

1970
01:42:33,280 --> 01:42:41,288
PREMATURE BABIES.

1971
01:42:41,288 --> 01:42:41,822
NOW IF WE HAVE SUPERVISED

1972
01:42:41,822 --> 01:42:42,923
MACHINE LEARNING WHAT ABOUT

1973
01:42:42,923 --> 01:42:46,961
UNSUPERVISED?

1974
01:42:46,961 --> 01:42:47,461
WE CAN ACTUALLY UTILIZE

1975
01:42:47,461 --> 01:42:50,531
UNSUPERVISED TO TAKE THE GUMBALL

1976
01:42:50,531 --> 01:42:55,002
MACHINE AND SEPARATE OUT THOSE

1977
01:42:55,002 --> 01:42:55,603
THINGS IN THE GUMBALL MACHINE

1978
01:42:55,603 --> 01:42:56,870
HERE I'M USING A DIFFERENT

1979
01:42:56,870 --> 01:42:59,473
ANALOGY WITH DIFFERENT KINDS OF

1980
01:42:59,473 --> 01:43:02,242
FRUIT.

1981
01:43:02,242 --> 01:43:03,310
WE HAVE A BASKET OF FRUIT WE

1982
01:43:03,310 --> 01:43:07,881
WANT TO SEPARATE INTO

1983
01:43:07,881 --> 01:43:08,415
STRAWBERRIES, BANANAS AND

1984
01:43:08,415 --> 01:43:10,484
ORANGES WE CAN USE UNSUPERVISED

1985
01:43:10,484 --> 01:43:15,623
APPROACH.

1986
01:43:15,623 --> 01:43:16,190
THAT TAKES FEATURES THAT ARE

1987
01:43:16,190 --> 01:43:16,824
CLOSELY RELATED TO 1 ANOTHER AND

1988
01:43:16,824 --> 01:43:17,458
PUTS THEM TOGETHER THEN BATCHES

1989
01:43:17,458 --> 01:43:18,425
AND CLUSTERS THEM.

1990
01:43:18,425 --> 01:43:21,028
THAT IS WHAT WE DID WITH 200

1991
01:43:21,028 --> 01:43:21,528
BABIES FROM THE NEONATAL

1992
01:43:21,528 --> 01:43:26,667
INTENSIVE CARE UNIT.

1993
01:43:26,667 --> 01:43:30,771
AND THIS IS FROM A PAPER THAT WE

1994
01:43:30,771 --> 01:43:32,272
PUBLISH FROM PEDIATRIC RESEARCH

1995
01:43:32,272 --> 01:43:33,507
AND 2024.

1996
01:43:33,507 --> 01:43:44,051
THIS IS THE DIFFERENT BABIES AND

1997
01:43:45,285 --> 01:43:45,853
Y AXIS YOU CANNOT READ THIS VERY

1998
01:43:45,853 --> 01:43:46,420
WELL BUT THESE ARE DIFFERENT

1999
01:43:46,420 --> 01:43:46,987
FEATURES AND WE COULD FIND 5

2000
01:43:46,987 --> 01:43:49,423
DIFFERENT CLUSTERS OF INTESTINAL

2001
01:43:49,423 --> 01:43:57,164
INJURY ON THIS GROUP OF.

2002
01:43:57,164 --> 01:43:57,798
WE ARE NOT LABELING THEM AS ANY

2003
01:43:57,798 --> 01:43:58,232
PARTICULAR DISEASE.

2004
01:43:58,232 --> 01:44:02,936
BUT WE HAVE 1 CLUSTER THAT

2005
01:44:02,936 --> 01:44:04,038
NEEDED TO GO TO SURGERY.

2006
01:44:04,038 --> 01:44:05,472
ANOTHER CLUSTER WITH ANOTHER

2007
01:44:05,472 --> 01:44:07,541
LEUKOCYTE PSYCHOSIS ANOTHER

2008
01:44:07,541 --> 01:44:12,346
PREMATURE BABIES WITH EARLY

2009
01:44:12,346 --> 01:44:12,746
INTESTINAL INJURY.

2010
01:44:12,746 --> 01:44:16,350
THIS IS 1 WAY WE COULD ACTUALLY

2011
01:44:16,350 --> 01:44:16,850
LOOK AT THESE DIFFERENT

2012
01:44:16,850 --> 01:44:18,952
INTESTINAL INJURIES IN THE

2013
01:44:18,952 --> 01:44:23,123
BABIES.

2014
01:44:23,123 --> 01:44:23,691
NOW I JUST WANT TO SHOW YOU

2015
01:44:23,691 --> 01:44:23,891
THIS.

2016
01:44:23,891 --> 01:44:28,395
IT IS COMMENTARY WRITTEN FROM

2017
01:44:28,395 --> 01:44:36,303
STUDIES IN KANSAS RELATED AND

2018
01:44:36,303 --> 01:44:36,837
ARTIFICIAL INTELLIGENCE TO

2019
01:44:36,837 --> 01:44:37,404
CLASSIFY ACQUIRED INTESTINAL

2020
01:44:37,404 --> 01:44:38,238
INJURY AND PRETERM NEONATES A

2021
01:44:38,238 --> 01:44:41,975
NEW PERSPECTIVE.

2022
01:44:41,975 --> 01:44:42,609
I WILL BE THIS TO VERY QUICKLY.

2023
01:44:42,609 --> 01:44:45,546
IN CONCLUSION THE STUDY

2024
01:44:45,546 --> 01:44:48,248
REPRESENTS A PROMISING AND NEWER

2025
01:44:48,248 --> 01:44:50,250
APPROACH TO REDEFINING

2026
01:44:50,250 --> 01:44:55,322
INTESTINAL DISEASES.

2027
01:44:55,322 --> 01:44:56,590
WITH THE QUEST FOR BETTER

2028
01:44:56,590 --> 01:45:02,162
CLASSIFICATION OF ACQUIRED

2029
01:45:02,162 --> 01:45:02,730
DISEASES AND THE INTENT TO

2030
01:45:02,730 --> 01:45:03,464
DEVELOP TOOLS THAT CAN BE

2031
01:45:03,464 --> 01:45:05,599
APPLIED IN THE CLINICAL RESEARCH

2032
01:45:05,599 --> 01:45:06,734
SETTING SHOULD BE PARAMOUNT AND

2033
01:45:06,734 --> 01:45:11,238
THIS ENDEAVOR TO THE PATH OF

2034
01:45:11,238 --> 01:45:13,574
THEOLOGICAL MECHANISMS WHICH IN

2035
01:45:13,574 --> 01:45:18,245
TURN PROVIDES THERAPY.

2036
01:45:18,245 --> 01:45:18,879
WHAT ABOUT THESE MECHANISMS HOW

2037
01:45:18,879 --> 01:45:20,114
DO WE FIGURE OUT WHAT IS GOING

2038
01:45:20,114 --> 01:45:26,920
ON IN THESE CLUSTERS?

2039
01:45:26,920 --> 01:45:27,554
JUST HAVING THESE IS NOT ENOUGH

2040
01:45:27,554 --> 01:45:28,188
WE WANT TO KNOW WHAT IS GOING ON

2041
01:45:28,188 --> 01:45:31,658
AND TO DIFFERENTIATE IN 1

2042
01:45:31,658 --> 01:45:32,693
CLUSTER VERSUS THE OTHER.

2043
01:45:32,693 --> 01:45:37,664
1 WAY TO DO THIS IS CALLED

2044
01:45:37,664 --> 01:45:38,031
MULTI- ALL MIX.

2045
01:45:38,031 --> 01:45:41,602
I AM SURE YOU ARE AWARE OF THE

2046
01:45:41,602 --> 01:45:44,171
PARABLE OF THE 6 BLIND MEN ALL

2047
01:45:44,171 --> 01:45:52,112
TRYING TO LOOK AT THE STRUCTURE

2048
01:45:52,112 --> 01:45:54,648
AND THEY DON'T COLLABORATE.

2049
01:45:54,648 --> 01:45:57,951
1 OF THE THINGS THAT YOU CAN DO

2050
01:45:57,951 --> 01:45:59,186
WITH MULTIOMICS APPROACH NOT

2051
01:45:59,186 --> 01:46:03,557
JUST TAKE THE MICRO BIOME BUT

2052
01:46:03,557 --> 01:46:07,161
THE MULTIOMICS APPROACH TO

2053
01:46:07,161 --> 01:46:07,795
INTEGRATE THAT AND WITH THAT YOU

2054
01:46:07,795 --> 01:46:08,695
CAN FIND A SYSTEMS BIOLOGY

2055
01:46:08,695 --> 01:46:11,899
MECHANISM THAT GIVES YOU AN IDEA

2056
01:46:11,899 --> 01:46:17,771
WITH EACH 1 OF THOSE CLUSTERS.

2057
01:46:17,771 --> 01:46:18,906
HERE IS A STRATEGY FOR THE

2058
01:46:18,906 --> 01:46:23,243
FUTURE AND 1 POSSIBLE APPROACH.

2059
01:46:23,243 --> 01:46:26,780
GO BACK TO 1965 OR 1971 AND

2060
01:46:26,780 --> 01:46:29,283
MAKE-BELIEVE THE TERM

2061
01:46:29,283 --> 01:46:30,250
NECROTIZING ENTEROCOLITIS NEVER

2062
01:46:30,250 --> 01:46:40,294
EXISTED.

2063
01:46:40,294 --> 01:46:40,861
EVALUATE LARGE DATA SETS OF

2064
01:46:40,861 --> 01:46:41,428
PRETERM INFANTS WITH VARIOUS

2065
01:46:41,428 --> 01:46:46,567
FORMS OF FEEDINGS AND PERFORMED

2066
01:46:46,567 --> 01:46:52,172
UNSUPERVISED CLUSTERS AND THEN

2067
01:46:52,172 --> 01:46:53,073
PROSPECTIVELY CLUSTER THESE WITH

2068
01:46:53,073 --> 01:46:57,044
UNSUPERVISED AI AND THEN THE

2069
01:46:57,044 --> 01:46:59,546
INTEGRATED MULTIOMICS WHAT IS

2070
01:46:59,546 --> 01:47:06,787
GOING ON AND THEN THE BIOMARKERS

2071
01:47:06,787 --> 01:47:07,921
FOR EARLY DETECTION AND THEN

2072
01:47:07,921 --> 01:47:08,422
DEVELOP PREVENTATIVE AND

2073
01:47:08,422 --> 01:47:12,526
THERAPEUTIC MEASURES BASED ON

2074
01:47:12,526 --> 01:47:12,993
THE PATHOPHYSIOLOGICAL

2075
01:47:12,993 --> 01:47:14,962
MECHANISMS WITHIN EACH CLUSTER

2076
01:47:14,962 --> 01:47:17,397
BUT THEY WILL ALL HAVE DIFFERENT

2077
01:47:17,397 --> 01:47:18,765
NAMES THAN NECROTIZING

2078
01:47:18,765 --> 01:47:19,099
ENTEROCOLITIS.

2079
01:47:19,099 --> 01:47:25,405
THANK YOU FOR YOUR ATTENTION.

2080
01:47:25,405 --> 01:47:26,540
[APPLAUSE]

2081
01:47:26,540 --> 01:47:37,050
>> OUR NEXT SPEAKER TALK
VERY

2082
01:47:40,120 --> 01:47:40,587
PROVOCATIVE AS THE MEDICAL

2083
01:47:40,587 --> 01:47:44,391
EPIDEMIOLOGIST THE NATIONAL

2084
01:47:44,391 --> 01:47:44,992
CENTER OF INFECTIOUS DISEASES

2085
01:47:44,992 --> 01:47:47,661
AND KRIS WILL TALK ABOUT CASE

2086
01:47:47,661 --> 01:47:50,564
DEFINITIONS OF PRODUCTS MARKETED

2087
01:47:50,564 --> 01:47:54,067
AS PROBIOTICS AND IN VERY LOW

2088
01:47:54,067 --> 01:47:58,138
BIRTH WEIGHT INFANTS.

2089
01:47:58,138 --> 01:48:03,110
>> THANK YOU.

2090
01:48:03,110 --> 01:48:09,283
GOOD MORNING PERK I HAVE BEEN

2091
01:48:09,283 --> 01:48:09,816
ASKED TO TALK ABOUT SAFETY

2092
01:48:09,816 --> 01:48:18,558
SIGNALS AS WELL AS CASE STUDIES

2093
01:48:18,558 --> 01:48:19,192
TALKING ABOUT VLBW INFANTS AND

2094
01:48:19,192 --> 01:48:19,793
LOOK AT THE 2 FORMS OF PUBLIC

2095
01:48:19,793 --> 01:48:21,295
HEALTH TO FIND THE INFORMED

2096
01:48:21,295 --> 01:48:22,429
APPROACH.

2097
01:48:22,429 --> 01:48:32,773
I HAVE NO DISCLOSURES THAT THESE

2098
01:48:32,773 --> 01:48:33,340
ARE MY OWN VIEWS AND DO NOT

2099
01:48:33,340 --> 01:48:37,210
NECESSARILY REPRESENT THOSE SO

2100
01:48:37,210 --> 01:48:42,349
WE HAVE A FAIRLY BUSY AGENDA

2101
01:48:42,349 --> 01:48:48,121
TODAY.

2102
01:48:48,121 --> 01:48:56,997
WE HAVE MANY DIFFERENT TOPICS.

2103
01:48:56,997 --> 01:48:57,597
AND A VERY BUSY DISCUSSION ON

2104
01:48:57,597 --> 01:48:59,633
THERAPEUTIC PRODUCTS THAT CAN

2105
01:48:59,633 --> 01:49:02,469
EXPAND THAT I HAVE A SHORT TIME

2106
01:49:02,469 --> 01:49:06,473
HERE TO DELVE INTO THE

2107
01:49:06,473 --> 01:49:07,040
THERAPEUTIC PRODUCTS AS SEEN

2108
01:49:07,040 --> 01:49:12,913
THROUGH THE LENS OF HEALTH AND

2109
01:49:12,913 --> 01:49:15,415
TO HAVE LIVE BIO THERAPEUTIC

2110
01:49:15,415 --> 01:49:19,386
PRODUCTS AND THAT INCLUDES DATA

2111
01:49:19,386 --> 01:49:22,389
SHOWING THE EFFECT AND THEN

2112
01:49:22,389 --> 01:49:25,292
HIGHLIGHTING EFFORTS IT HAS BEEN

2113
01:49:25,292 --> 01:49:30,430
REPORTED TO LITERATURE AND THEN

2114
01:49:30,430 --> 01:49:30,864
SUMMARIZING CURRENT

2115
01:49:30,864 --> 01:49:31,498
RECOMMENDATIONS BY PROFESSIONALS

2116
01:49:31,498 --> 01:49:35,435
AND OTHER ORGANIZATIONS.

2117
01:49:35,435 --> 01:49:35,969
MOST IMPORTANTLY I HOPE TO

2118
01:49:35,969 --> 01:49:38,038
PROVIDE A PICTURE OF THE NATURAL

2119
01:49:38,038 --> 01:49:40,107
HISTORY OF THE LBP USE WITHIN

2120
01:49:40,107 --> 01:49:44,578
THE UNITED STATES AND ABROAD

2121
01:49:44,578 --> 01:49:45,212
SOME OF THIS HAS BEEN COVERED BY

2122
01:49:45,212 --> 01:49:46,213
SPEAKERS ALREADY AND OTHERS I

2123
01:49:46,213 --> 01:49:48,115
WILL BE FORESHADOWING GIVING

2124
01:49:48,115 --> 01:49:53,587
ADDITIONAL DETAIL.

2125
01:49:53,587 --> 01:49:54,254
THE FIRST THING I WANT TO DO IS

2126
01:49:54,254 --> 01:49:56,757
PROVIDE A FEW DEFINITIONS AND

2127
01:49:56,757 --> 01:49:59,159
I'M REFERRING TO DIFFERENT TERMS

2128
01:49:59,159 --> 01:50:02,429
TO DESCRIBE NEWBORNS AT

2129
01:50:02,429 --> 01:50:05,766
DIFFERENT GESTATIONAL AGES SO

2130
01:50:05,766 --> 01:50:07,300
HERE ARE A FEW OF THE

2131
01:50:07,300 --> 01:50:11,204
DEFINITIONS IF YOU ALREADY SAW

2132
01:50:11,204 --> 01:50:15,609
AND HEARD SOME OF THESE BUT THE

2133
01:50:15,609 --> 01:50:17,444
AVERAGE DURATION OF PREGNANCY OR

2134
01:50:17,444 --> 01:50:23,216
THE TERM IS 40 WEEKS THAT IS THE

2135
01:50:23,216 --> 01:50:23,750
MORE IMMATURE THE TIME OF

2136
01:50:23,750 --> 01:50:24,384
DELIVERY AND THE MORE VULNERABLE

2137
01:50:24,384 --> 01:50:29,556
THEY ARE TO PHYSIOLOGICAL STRESS

2138
01:50:29,556 --> 01:50:29,990
INCLUDING INFECTION.

2139
01:50:29,990 --> 01:50:32,259
PRETERM OFFENSE FOR LESS THAN 28

2140
01:50:32,259 --> 01:50:34,795
WEEKS OFTEN HAVE THE HIGHEST

2141
01:50:34,795 --> 01:50:39,232
RISK.

2142
01:50:39,232 --> 01:50:39,833
THE SAME GOES FOR BIRTH WEIGHT

2143
01:50:39,833 --> 01:50:41,868
BEING ABOUT 7 POUNDS WITH

2144
01:50:41,868 --> 01:50:44,304
3200 GRAMS HOWEVER WE HAVE

2145
01:50:44,304 --> 01:50:51,611
HIGHER RISK NEONATES THAT ARE

2146
01:50:51,611 --> 01:50:52,145
BORN AT 1500 GRAMS OR VERY

2147
01:50:52,145 --> 01:50:58,518
LITTLE BIRTH WEIGHT OVER THOSE

2148
01:50:58,518 --> 01:50:59,152
THAT ARE AT EXTREMELY LOW BIRTH

2149
01:50:59,152 --> 01:50:59,753
WEIGHT AT 1000 GRAMS OR LESS.

2150
01:50:59,753 --> 01:51:02,089
I ALSO WANT TO BE UP FRONT ABOUT

2151
01:51:02,089 --> 01:51:06,159
MY USE OF THE TERM LBP.

2152
01:51:06,159 --> 01:51:07,794
THEY CAN BE REFERRED TO AS

2153
01:51:07,794 --> 01:51:11,098
PROBIOTICS BUT AS MENTIONED

2154
01:51:11,098 --> 01:51:11,932
EARLIER THOSE ARE NOT ALWAYS

2155
01:51:11,932 --> 01:51:16,103
EASY TO DEFINE.

2156
01:51:16,103 --> 01:51:18,705
LBP ARE PRODUCTS THAT CONTAIN

2157
01:51:18,705 --> 01:51:22,142
ORGANISMS AND USE TO PREVENT OR

2158
01:51:22,142 --> 01:51:26,680
CURE IDS OR CONDITION AND ALSO

2159
01:51:26,680 --> 01:51:27,314
NOT CONSIDERED TO BE A VACCINES

2160
01:51:27,314 --> 01:51:30,016
ARE CURRENTLY WE DO NOT HAVE ANY

2161
01:51:30,016 --> 01:51:34,354
LBP'S FOR US AND I WILL USE THAT

2162
01:51:34,354 --> 01:51:40,927
FOR MY PRESENTATION SO NOW THAT

2163
01:51:40,927 --> 01:51:42,129
WE HAVE THE DEFINITIONS OUT OF

2164
01:51:42,129 --> 01:51:44,598
THE WAY I WANT TO TALK ABOUT THE

2165
01:51:44,598 --> 01:51:46,299
IMPACT AND HOW IT AFFECTS VERY

2166
01:51:46,299 --> 01:51:50,570
LOW BIRTH WEIGHT UNITS AND

2167
01:51:50,570 --> 01:51:51,104
SHOWING THIS FROM THE NEXT

2168
01:51:51,104 --> 01:51:53,073
SOCIETY BECAUSE DIGITALLY IT

2169
01:51:53,073 --> 01:52:03,583
SHOWS THE IMPACT BETTER THAN I

2170
01:52:03,817 --> 01:52:04,117
CAN DESCRIBE IT.

2171
01:52:04,117 --> 01:52:04,718
WE HEARD EARLIER THIS MORNING

2172
01:52:04,718 --> 01:52:05,352
ABOUT THE DEVASTATING EFFECT ON

2173
01:52:05,352 --> 01:52:05,952
BOTH NEONATES AND FAMILIES AND

2174
01:52:05,952 --> 01:52:06,520
NOT TO REHASH WHAT HAS BEEN

2175
01:52:06,520 --> 01:52:07,120
DISCUSSED BUT TO SUMMARIES WE

2176
01:52:07,120 --> 01:52:12,292
ESTIMATE BETWEEN 3500 NEONATES

2177
01:52:12,292 --> 01:52:12,926
ARE DIAGNOSED EACH YEAR AND THAT

2178
01:52:12,926 --> 01:52:13,527
LEADS TO 1 BABY DYING FROM NEC

2179
01:52:13,527 --> 01:52:14,594
EACH DAY IT HAS A

2180
01:52:14,594 --> 01:52:20,634
DISPROPORTIONATELY HIGHER RATE

2181
01:52:20,634 --> 01:52:21,268
OF BLACK INFANTS AND YOU CAN SEE

2182
01:52:21,268 --> 01:52:24,171
INCIDENCE OF NEC THAT HAS

2183
01:52:24,171 --> 01:52:29,042
DECREASED OVER TIME.

2184
01:52:29,042 --> 01:52:29,643
BUT WE HAVE MORE WORK TO DO TO

2185
01:52:29,643 --> 01:52:30,177
KEEP THE HIGHLY VULNERABLE

2186
01:52:30,177 --> 01:52:33,313
INFANT SAFE SUCH A DEVASTATING

2187
01:52:33,313 --> 01:52:34,548
DISEASE RESEARCHERS HAVE BEEN

2188
01:52:34,548 --> 01:52:39,186
LOOKING FOR WAYS.

2189
01:52:39,186 --> 01:52:49,729
1 OF THE WAYS TO PREVENT THIS AS

2190
01:52:50,430 --> 01:52:50,997
IT PROVIDES PROTECTIVE BENEFITS

2191
01:52:50,997 --> 01:52:51,565
TO THE NEONATE AND THE MICRO

2192
01:52:51,565 --> 01:52:53,867
BIOME 1 OF THE FIRST REPORTS IS

2193
01:52:53,867 --> 01:52:56,336
BEING PROTECTIVE SEEING IN THE

2194
01:52:56,336 --> 01:53:03,009
REPORT THEY SHOW THE CHOICE

2195
01:53:03,009 --> 01:53:03,677
PLAYED A PART IN THE ASSOCIATION

2196
01:53:03,677 --> 01:53:08,281
OF THE DEVELOPMENT AND CONFIRMED

2197
01:53:08,281 --> 01:53:10,517
CASES WERE 6 TIMES HIGHER AMONG

2198
01:53:10,517 --> 01:53:12,819
INFANTS AS COMPARED TO INFANTS

2199
01:53:12,819 --> 01:53:20,827
WHO RECEIVED MILK PRODUCTS FOR

2200
01:53:20,827 --> 01:53:21,428
HUMAN MILK PROMPTED PRODUCTS.

2201
01:53:21,428 --> 01:53:22,028
HAVING PROTECTED BENEFITS THAT

2202
01:53:22,028 --> 01:53:25,565
WE HEARD ABOUT THIS MORNING

2203
01:53:25,565 --> 01:53:28,134
INCLUDING WE AFFIRMING THE

2204
01:53:28,134 --> 01:53:33,406
FINDINGS AFTER CONVENING THE

2205
01:53:33,406 --> 01:53:40,914
WORKSHOP HHS FDA CDC GAVE A

2206
01:53:40,914 --> 01:53:42,315
JOINT STATEMENT BASICALLY SAYING

2207
01:53:42,315 --> 01:53:43,550
THERE IS NO CONCLUSIVE EVIDENCE

2208
01:53:43,550 --> 01:53:46,386
THAT CONCLUDES AND THAT THERE IS

2209
01:53:46,386 --> 01:53:48,121
STRONG EVIDENCE THAT HUMAN FOCUS

2210
01:53:48,121 --> 01:53:58,531
PROTECTED AGAINST THAT.

2211
01:54:04,237 --> 01:54:04,804
IT IS NOT COMPLETELY PROTECTED

2212
01:54:04,804 --> 01:54:05,372
RESEARCHERS HAVE WAYS OF THE

2213
01:54:05,372 --> 01:54:05,939
HIGHER RISK NEONATES THAT IS

2214
01:54:05,939 --> 01:54:06,573
CONSIDERED A POTENTIAL WAY TO DO

2215
01:54:06,573 --> 01:54:07,207
THAT AND THE THOUGHT WAS TO HAVE

2216
01:54:07,207 --> 01:54:12,846
A FAVORABLE MICRO BIOME.

2217
01:54:12,846 --> 01:54:13,480
AS WELL AS SUBSEQUENT DAMAGE SO

2218
01:54:13,480 --> 01:54:14,080
THERE'S A NUMBER OF TRIALS AND

2219
01:54:14,080 --> 01:54:14,681
STUDIES AND THE OVERALL EFFECT

2220
01:54:14,681 --> 01:54:17,917
ON SEPSIS NECROTIZING

2221
01:54:17,917 --> 01:54:18,418
ENTEROCOLITIS AS WELL AS

2222
01:54:18,418 --> 01:54:22,188
MORTALITY AND THE FIRST STUDY

2223
01:54:22,188 --> 01:54:29,195
WAS IN 1999 AND THE SLIDE ONCE

2224
01:54:29,195 --> 01:54:30,130
WE WILL GO OVER LATER BUT I WANT

2225
01:54:30,130 --> 01:54:39,572
TO HIGHLIGHT THESE STUDIES HAVE

2226
01:54:39,572 --> 01:54:40,073
MIXED RESULTS OVER TIME.

2227
01:54:40,073 --> 01:54:40,707
SOME FAVOR THE USE WHILE OTHERS

2228
01:54:40,707 --> 01:54:41,274
SO LITTLE OR NO STATISTICAL

2229
01:54:41,274 --> 01:54:42,776
SIGNIFICANCE FOR THEIR ROLE.

2230
01:54:42,776 --> 01:54:47,914
INCLUDING THE MOST RECENT

2231
01:54:47,914 --> 01:54:51,151
SHOWING LBP'S COULD REDUCE THE

2232
01:54:51,151 --> 01:54:55,322
VERY LOW BIRTH WEIGHT NEONATES

2233
01:54:55,322 --> 01:54:57,891
THIS IS DUE TO THE QUALITY OF

2234
01:54:57,891 --> 01:55:02,495
EVIDENCE THAT WERE USED AS WELL

2235
01:55:02,495 --> 01:55:10,437
AS OTHER FACTORS.

2236
01:55:10,437 --> 01:55:10,937
AND THEN WE HAVE REPORTS

2237
01:55:10,937 --> 01:55:15,141
INCREASED SEEING USE OVER TIME

2238
01:55:15,141 --> 01:55:15,809
OF VERY LOW BIRTH WEIGHT INFANTS

2239
01:55:15,809 --> 01:55:20,480
HOWEVER ON SEPTEMBER 29 ISSUED A

2240
01:55:20,480 --> 01:55:31,024
DEAR HEALTHCARE PROVIDER LETTER

2241
01:55:33,827 --> 01:55:34,394
AFTER AN INVESTIGATION INTO THE

2242
01:55:34,394 --> 01:55:34,961
DEATH OF AN INFANT THAT HAS

2243
01:55:34,961 --> 01:55:35,595
ADMINISTERED 1 OF THESE PRODUCTS

2244
01:55:35,595 --> 01:55:36,129
THE INFANT WAS PRETERM AND

2245
01:55:36,129 --> 01:55:36,730
EXTREMELY LOW BIRTH WEIGHT AND

2246
01:55:36,730 --> 01:55:44,104
WAS GIVEN L BT AS WELL AS THE

2247
01:55:44,104 --> 01:55:48,375
OIL AND THAT BECAME SEPTIC AND

2248
01:55:48,375 --> 01:55:49,642
THE ORGANISM WAS CULTURED FROM

2249
01:55:49,642 --> 01:55:51,711
THE INFANTS BLOOD AND THE

2250
01:55:51,711 --> 01:55:53,179
CULTURE BACTERIA WITH SEQUENCING

2251
01:55:53,179 --> 01:55:58,685
MATCH THAT WAS CONTAINED IS 1 OF

2252
01:55:58,685 --> 01:56:05,258
THE REASONS WE ARE HERE TODAY.

2253
01:56:05,258 --> 01:56:05,925
AND THIS LETTER THE FDA REMINDED

2254
01:56:05,925 --> 01:56:06,559
PROVIDERS THERE IS NO PROBIOTICS

2255
01:56:06,559 --> 01:56:08,261
FOR USE AS A DRUG OR BIOLOGIC

2256
01:56:08,261 --> 01:56:10,830
PRODUCT IN INFANTS AND THERE

2257
01:56:10,830 --> 01:56:16,136
COULD BE A SERIES OF ADVERSE

2258
01:56:16,136 --> 01:56:22,342
EFFECTS WITH THESE PRODUCTS.

2259
01:56:22,342 --> 01:56:23,009
CONTAINING LIVE ORGANISMS AND IF

2260
01:56:23,009 --> 01:56:24,110
THEY ESCAPE OUT OF THE

2261
01:56:24,110 --> 01:56:31,384
INTESTINES THERE IS THE

2262
01:56:31,384 --> 01:56:31,918
POTENTIAL IT CAN CAUSE AN

2263
01:56:31,918 --> 01:56:32,185
INFECTION.

2264
01:56:32,185 --> 01:56:32,819
THERE HAVE BEEN REPORTS OF SUCH

2265
01:56:32,819 --> 01:56:33,887
CASES IN MEDICAL LITERATURE FOR

2266
01:56:33,887 --> 01:56:39,225
AN EXAMPLE OF THIS REPORT

2267
01:56:39,225 --> 01:56:41,828
DESCRIBING HOW THE NICU IN

2268
01:56:41,828 --> 01:56:46,800
NORWAY BEGAN USING AS A

2269
01:56:46,800 --> 01:56:49,202
PROPHYLAXIS AT 28 WEEKS OF

2270
01:56:49,202 --> 01:56:53,907
GESTATION.

2271
01:56:53,907 --> 01:56:56,576
THEY ADMINISTERED LBP'S TO 290

2272
01:56:56,576 --> 01:56:58,278
INFANTS THROUGH 2015 AND

2273
01:56:58,278 --> 01:57:01,881
DESCRIBED 3 THAT DEVELOPED

2274
01:57:01,881 --> 01:57:06,085
SEPSIS WHICH IS THE SAME AS LBP

2275
01:57:06,085 --> 01:57:09,622
GIVEN TO THE FENCE.

2276
01:57:09,622 --> 01:57:11,191
SO I HAVE THE ADDITIONAL

2277
01:57:11,191 --> 01:57:11,791
CHARACTERISTICS SHOWN ON THE

2278
01:57:11,791 --> 01:57:20,333
TABLE ON THE RIGHT.

2279
01:57:20,333 --> 01:57:20,900
THE AUTHORS HERE POINTED OUT

2280
01:57:20,900 --> 01:57:21,468
THEY DON'T KNOW WHETHER THE

2281
01:57:21,468 --> 01:57:22,068
ORGANISM OR THE CULTURE WAS A

2282
01:57:22,068 --> 01:57:27,574
CONSEQUENCE OF NECROTIZING

2283
01:57:27,574 --> 01:57:32,045
ENTEROCOLITIS ITSELF AND HAVING

2284
01:57:32,045 --> 01:57:34,848
THE OUTCOMES FOR THESE AND YOU

2285
01:57:34,848 --> 01:57:45,258
WILL SEE FROM THE NICU.

2286
01:57:45,258 --> 01:57:45,725
SO I JUST MENTIONED

2287
01:57:45,725 --> 01:57:46,359
TRANSLOCATION I THOUGHT IT WOULD

2288
01:57:46,359 --> 01:57:46,993
BE HELPFUL TO BRIEFLY RECAP WHAT

2289
01:57:46,993 --> 01:57:48,094
THAT IMPLIES OR MEANS SO BEAR

2290
01:57:48,094 --> 01:57:53,733
WITH MY ART SKILLS.

2291
01:57:53,733 --> 01:57:54,334
I KNOW THEY ARE NOT GREAT BUT

2292
01:57:54,334 --> 01:57:55,535
THE DRAWING ON THE LEFT IS

2293
01:57:55,535 --> 01:57:57,837
REPRESENTED IN THE NEONATAL AND

2294
01:57:57,837 --> 01:58:03,076
ON THE RIGHT IT WAS DAMAGED BY

2295
01:58:03,076 --> 01:58:03,643
EITHER INFLAMMATION OR SOME

2296
01:58:03,643 --> 01:58:04,511
OTHER TYPE OF INTESTINAL

2297
01:58:04,511 --> 01:58:04,744
INJURY.

2298
01:58:04,744 --> 01:58:11,284
IT IS VERY SIMPLISTIC BUT IS

2299
01:58:11,284 --> 01:58:19,225
SOME OTHER TYPE OF INSULTS.

2300
01:58:19,225 --> 01:58:19,826
THE INTESTINES ARE FILLED WITH

2301
01:58:19,826 --> 01:58:20,460
MICROBES IT IS ESTIMATED WITHIN

2302
01:58:20,460 --> 01:58:23,763
THE FIRST MONTH OF LIFE NEONATES

2303
01:58:23,763 --> 01:58:32,105
HAVE BILLIONS OF INTESTINAL

2304
01:58:32,105 --> 01:58:36,743
CONTENT AND THEN WE ATTEMPT TO

2305
01:58:36,743 --> 01:58:37,377
INFLUENCE THE MICROBIAL MAKE UP

2306
01:58:37,377 --> 01:58:37,977
OF THE INTESTINES WHEN THE GUT

2307
01:58:37,977 --> 01:58:38,545
IS HEALTHY MICROBES CONTINUE

2308
01:58:38,545 --> 01:58:42,549
WITHIN THE GUT HOWEVER WITH

2309
01:58:42,549 --> 01:58:43,116
INJURY OR INFLAMMATION COULD

2310
01:58:43,116 --> 01:58:44,217
ALLOW THESE ORGANISMS TO RECAP

2311
01:58:44,217 --> 01:58:52,191
THE INTESTINES AND GOING INTO

2312
01:58:52,191 --> 01:58:52,825
THE LYMPHATIC TISSUE OR INTO THE

2313
01:58:52,825 --> 01:58:53,393
BLOODSTREAM IF THEY ARE NOT

2314
01:58:53,393 --> 01:58:54,727
FOUND AND KILLED BY THE IMMUNE

2315
01:58:54,727 --> 01:58:59,832
SYSTEM AS POSSIBLE THEY COULD

2316
01:58:59,832 --> 01:59:00,400
MULTIPLY AND CAUSE SEPSIS OR

2317
01:59:00,400 --> 01:59:00,934
ANOTHER FORM OF INFECTION.

2318
01:59:00,934 --> 01:59:01,935
IT IS A BASIC DESCRIPTION BUT

2319
01:59:01,935 --> 01:59:07,440
CONSIDERED TO BE A LIKELY WAY

2320
01:59:07,440 --> 01:59:13,112
WHEN IT IS ADMINISTERED.

2321
01:59:13,112 --> 01:59:14,213
IT'S NOT JUST BACTERIA WE NEED

2322
01:59:14,213 --> 01:59:17,584
TO BE CONCERNED ABOUT.

2323
01:59:17,584 --> 01:59:18,217
ALSO FUNGI HAVE BEEN REPORTED AS

2324
01:59:18,217 --> 01:59:20,053
A CAUSE OF SEPSIS.

2325
01:59:20,053 --> 01:59:24,157
THERE IS A STUDY WHERE THE

2326
01:59:24,157 --> 01:59:31,998
AUTHORS OF THE STUDY DESCRIBED.

2327
01:59:31,998 --> 01:59:33,600
>> IT WAS FOR THE HOSPITAL

2328
01:59:33,600 --> 01:59:36,302
PROTOCOL TO NEONATES BECAME

2329
01:59:36,302 --> 01:59:43,509
SEPTIC.

2330
01:59:43,509 --> 01:59:44,611
AND THE AUTHORS COMPARED THE

2331
01:59:44,611 --> 01:59:45,211
FUNGI USED IN SEQUENCING, THEY

2332
01:59:45,211 --> 01:59:48,081
FOUND THE FUNGI WAS ROUGHLY

2333
01:59:48,081 --> 01:59:49,716
90 PERCENT SIMILAR LEADING THEM

2334
01:59:49,716 --> 01:59:58,391
TO THE CONCLUSION THE RECOVERED

2335
01:59:58,391 --> 01:59:58,992
STRINGS MATCH THE ADMINISTERED

2336
01:59:58,992 --> 02:00:02,362
PRODUCT THEY ALSO SUSPECTED

2337
02:00:02,362 --> 02:00:02,962
TRANSLOCATION OR ENVIRONMENTAL

2338
02:00:02,962 --> 02:00:04,931
CONTAMINATION AS A CONTRIBUTING

2339
02:00:04,931 --> 02:00:09,268
FACTOR THEY DID DIE

2340
02:00:09,268 --> 02:00:10,169
UNFORTUNATELY BUT THE AUTHORS

2341
02:00:10,169 --> 02:00:12,438
ATTRIBUTED THE DEATH TO MAJOR

2342
02:00:12,438 --> 02:00:21,247
UNDERLYING CARDIAC MALFORMATIONS

2343
02:00:21,247 --> 02:00:21,914
THE OTHER INFANT DID RECOVER AND

2344
02:00:21,914 --> 02:00:24,517
WAS DISCHARGED FROM THE NICU.

2345
02:00:24,517 --> 02:00:31,190
THERE IS SOME EVIDENCE THOSE

2346
02:00:31,190 --> 02:00:35,461
THAT CAN NEVER BE PRESCRIBED AND

2347
02:00:35,461 --> 02:00:36,329
AN EXAMPLE OF THIS IS A HOSPITAL

2348
02:00:36,329 --> 02:00:44,537
IN ITALY BEGAN ADMINISTERING IN

2349
02:00:44,537 --> 02:00:54,080
2017.

2350
02:00:54,080 --> 02:00:54,580
ONLY 1 OF THESE NEONATES

2351
02:00:54,580 --> 02:00:55,081
ACTUALLY RECEIVE THE LVT

2352
02:00:55,081 --> 02:00:55,682
HOSPITAL PROTOCOL.

2353
02:00:55,682 --> 02:01:02,088
TO OTHER NEONATES THAT WERE

2354
02:01:02,088 --> 02:01:02,689
NEVER GIVEN THE LBP STAYED IN

2355
02:01:02,689 --> 02:01:03,289
THE SAME ROOM AS IS INFANT AND

2356
02:01:03,289 --> 02:01:05,158
THE RESEARCH TEAM ANALYZED THE

2357
02:01:05,158 --> 02:01:09,429
SIMILARITY OF ORGANISMS

2358
02:01:09,429 --> 02:01:10,029
RECOVERED FROM THE 3 NEONATES

2359
02:01:10,029 --> 02:01:10,630
AND THAT THEY ARE ALL THE SAME

2360
02:01:10,630 --> 02:01:12,131
AS ADMINISTERED PRODUCT.

2361
02:01:12,131 --> 02:01:14,233
THEY STATE THERE ARE SEVERAL

2362
02:01:14,233 --> 02:01:17,904
DIFFERENT MODES OF TRANSMISSION

2363
02:01:17,904 --> 02:01:21,808
FOR THE CONTAMINATION FROM THE

2364
02:01:21,808 --> 02:01:22,408
LBP ITSELF AND ON THE HANDS OF

2365
02:01:22,408 --> 02:01:25,611
HEALTHCARE PROVIDERS.

2366
02:01:25,611 --> 02:01:31,084
WE TAKE THIS HYPOTHESIS A STEP

2367
02:01:31,084 --> 02:01:31,317
FURTHER.

2368
02:01:31,317 --> 02:01:37,557
PUBLISHING A STUDY FROM THE TIME

2369
02:01:37,557 --> 02:01:45,898
THE PACKET WAS OPENED.

2370
02:01:45,898 --> 02:01:46,466
I HAVE SOME OF THE SAMPLING

2371
02:01:46,466 --> 02:01:47,033
RESULTS ON THE TABLE ON THE

2372
02:01:47,033 --> 02:01:50,136
RIGHT-HAND SIDE THE SURFACE THE

2373
02:01:50,136 --> 02:01:50,670
LEAD IS SAMPLED IS IN THE

2374
02:01:50,670 --> 02:01:52,138
LEFT-HAND COLUMN IN THE COLONY

2375
02:01:52,138 --> 02:01:57,510
FORMING UNITS ARE DETECTED IN

2376
02:01:57,510 --> 02:01:58,111
THE RIGHT-HAND COLUMN AND YOU

2377
02:01:58,111 --> 02:02:01,047
CAN SEE THE PACKET WAS OPENED IN

2378
02:02:01,047 --> 02:02:03,816
THIS ORGANISM WAS RECOVERED FROM

2379
02:02:03,816 --> 02:02:12,792
THE IMPACTED AREA AND SING IT

2380
02:02:12,792 --> 02:02:13,392
WAS MASSIVE AIR CONTAMINATION

2381
02:02:13,392 --> 02:02:13,960
ALTHOUGH IT DID CLEAR AND NO

2382
02:02:13,960 --> 02:02:16,462
FURTHER ORGANISMS WERE DETECTED

2383
02:02:16,462 --> 02:02:16,829
AFTER 1 HOUR.

2384
02:02:16,829 --> 02:02:20,399
ALSO WITH THAT DISPERSION OF THE

2385
02:02:20,399 --> 02:02:23,770
ORGANISM OF NEARBY ENVIRONMENTAL

2386
02:02:23,770 --> 02:02:25,505
SERVICES THOSE THAT WERE

2387
02:02:25,505 --> 02:02:29,308
DETECTED WITHIN 2 HOURS.

2388
02:02:29,308 --> 02:02:29,842
THEY ALSO SAW THAT CANCER

2389
02:02:29,842 --> 02:02:31,544
TECHNICIANS WHO OPENED THE

2390
02:02:31,544 --> 02:02:33,012
PACKET HAD SIGNIFICANTLY

2391
02:02:33,012 --> 02:02:36,516
CONTAMINATED THEIR HANDS PRIOR

2392
02:02:36,516 --> 02:02:38,684
TO WATCHING THEM THIS WAS

2393
02:02:38,684 --> 02:02:42,822
EVIDENCED BY WHAT WAS CULTURED

2394
02:02:42,822 --> 02:02:48,394
EVEN AFTER VIGOROUS HANDWASHING

2395
02:02:48,394 --> 02:02:48,961
57 SEE IF USE WERE DETECTED

2396
02:02:48,961 --> 02:02:50,663
AFTER THEY WASH THEIR HANDS OF

2397
02:02:50,663 --> 02:02:53,266
THIS SUGGEST LBP'S CAN LEAD TO

2398
02:02:53,266 --> 02:02:58,638
INADVERTENT TRANSMISSION OF

2399
02:02:58,638 --> 02:02:59,205
ORGANIZED ORGANISMS THROUGH

2400
02:02:59,205 --> 02:02:59,906
SERVICES OR THROUGH HEALTHCARE

2401
02:02:59,906 --> 02:03:02,275
PROVIDERS WHICH CONTINUES TO

2402
02:03:02,275 --> 02:03:05,645
REINFORCE HIGH-QUALITY INVENTION

2403
02:03:05,645 --> 02:03:08,247
AND PREVENTION PRACTICES WITH

2404
02:03:08,247 --> 02:03:09,816
GOOD ENVIRONMENTAL CLEANING

2405
02:03:09,816 --> 02:03:13,786
SERVICES FOR SHARED MEDICAL

2406
02:03:13,786 --> 02:03:14,987
EQUIPMENT AND THEN HYGIENE FOR

2407
02:03:14,987 --> 02:03:19,792
HEALTHCARE PROVIDERS.

2408
02:03:19,792 --> 02:03:28,601
LBP'S ARE INTENTIONALLY NOT A

2409
02:03:28,601 --> 02:03:29,168
STERILE PRODUCT AND NEED TO

2410
02:03:29,168 --> 02:03:29,769
CONTINUE WITH LIVING ORGANISMS

2411
02:03:29,769 --> 02:03:30,369
TO HAVE THEIR EFFECT AND THAT

2412
02:03:30,369 --> 02:03:33,272
OPENS THE POSSIBILITY THEY CAN

2413
02:03:33,272 --> 02:03:34,574
BECOME CONTAMINATED WITH

2414
02:03:34,574 --> 02:03:37,543
UNINTENDED ORGANISMS THAT THEY

2415
02:03:37,543 --> 02:03:38,945
ARE NOT METICULOUSLY FOLLOWED.

2416
02:03:38,945 --> 02:03:45,351
1 EXAMPLE IS DURING AN

2417
02:03:45,351 --> 02:03:45,852
INVESTIGATION FDA CDC IN

2418
02:03:45,852 --> 02:03:46,485
CONNECTICUT DEPARTMENT OF HEALTH

2419
02:03:46,485 --> 02:03:52,692
AFTER A FETAL INFECTION AND A

2420
02:03:52,692 --> 02:03:53,326
PRETERM INFANT IN 2014 THIS WORD

2421
02:03:53,326 --> 02:03:57,730
IS ADMINISTERED MANUFACTURER TO

2422
02:03:57,730 --> 02:04:06,672
HAVE THE INFANT HAD SURGICAL

2423
02:04:06,672 --> 02:04:08,741
RECEPTION OF THE INTESTINES AND

2424
02:04:08,741 --> 02:04:11,377
PATHOLOGIC SPECIMENS SHOWED A

2425
02:04:11,377 --> 02:04:16,182
HEAVY BURDEN THE PRODUCT

2426
02:04:16,182 --> 02:04:17,850
INCLUDING UNOPENED BOTTLES WAS

2427
02:04:17,850 --> 02:04:20,753
TESTED THAT COULD HAVE BEEN

2428
02:04:20,753 --> 02:04:22,455
CONTAMINATION AND WHEN IT WAS

2429
02:04:22,455 --> 02:04:26,192
TESTED THEY IDENTIFIED WITHIN

2430
02:04:26,192 --> 02:04:29,662
THE UNOPENED BOTTLES OF THE

2431
02:04:29,662 --> 02:04:32,498
PRODUCT SO THE MAP ON THE RIGHT

2432
02:04:32,498 --> 02:04:35,902
SHOWS THOSE IN GREEN WAS WIDELY

2433
02:04:35,902 --> 02:04:39,005
DISTRIBUTED ACROSS THE US SO

2434
02:04:39,005 --> 02:04:41,507
CONTAMINATION WITH UNINTENDED

2435
02:04:41,507 --> 02:04:44,477
ORGANISMS LEADING TO

2436
02:04:44,477 --> 02:04:45,111
COLONIZATION AS WELL AS POSSIBLE

2437
02:04:45,111 --> 02:04:46,812
INFECTION AND SERVES AS A

2438
02:04:46,812 --> 02:04:50,583
REMINDER THE QUALITY AND SAFETY

2439
02:04:50,583 --> 02:04:51,150
OF THE THERAPIES NEED TO BE

2440
02:04:51,150 --> 02:04:51,751
INSURED FOR THE SAFETY OF OUR

2441
02:04:51,751 --> 02:04:55,955
PATIENTS.

2442
02:04:55,955 --> 02:04:56,622
THERE ARE MANY MORE STUDIES THAN

2443
02:04:56,622 --> 02:04:59,959
I HAVE TIME TO DISCUSS THEY WANT

2444
02:04:59,959 --> 02:05:00,826
TO BRING YOUR ATTENTION TO THE

2445
02:05:00,826 --> 02:05:07,967
SYSTEMATIC REVIEW WHICH IS 16

2446
02:05:07,967 --> 02:05:08,467
ARTICLES AND INCLUDES 32

2447
02:05:08,467 --> 02:05:09,435
REPORTED CASES OF NEONATAL

2448
02:05:09,435 --> 02:05:12,438
SEPSIS.

2449
02:05:12,438 --> 02:05:14,907
THE PIE CHART HERE SHOWS THE

2450
02:05:14,907 --> 02:05:15,641
BREAKDOWN THAT IS ADMINISTERED

2451
02:05:15,641 --> 02:05:18,377
TO THE INFANTS AND YOU CAN SEE

2452
02:05:18,377 --> 02:05:20,680
THESE VERY AMONG THE DIFFERENT

2453
02:05:20,680 --> 02:05:25,084
REPORTS I HAVE SUMMARIZED

2454
02:05:25,084 --> 02:05:25,584
DETAILS LIKE GESTATIONAL

2455
02:05:25,584 --> 02:05:26,218
AGE, BIRTH WEIGHT AND SIGNS OF

2456
02:05:26,218 --> 02:05:29,155
INFECTION BUT INTERESTINGLY THE

2457
02:05:29,155 --> 02:05:33,392
ONLY 1 THAT WAS REPORTED LIKELY

2458
02:05:33,392 --> 02:05:36,729
RELATED TO THE UNDERLYING

2459
02:05:36,729 --> 02:05:37,396
CARDIAC ISSUES DISCUSSED EARLIER

2460
02:05:37,396 --> 02:05:42,268
IT ALSO DOES NOT INCLUDE FROM

2461
02:05:42,268 --> 02:05:42,868
THE HEALTH CARE PROVIDER LATER

2462
02:05:42,868 --> 02:05:51,544
OR THE NEONATE FROM THE

2463
02:05:51,544 --> 02:05:52,144
CONTAMINATED PRODUCT BUT I DO

2464
02:05:52,144 --> 02:05:52,778
WANT TO HIGHLIGHT MANY OF THESE

2465
02:05:52,778 --> 02:05:53,379
DID REQUIRE SURGICAL RESECTION

2466
02:05:53,379 --> 02:05:59,051
OF THE BOWEL AND HAD LINES

2467
02:05:59,051 --> 02:05:59,685
REMOVED TO IMPAIR ACCESS OR HAD

2468
02:05:59,685 --> 02:06:00,219
AN INCREASE OF RESPIRATORY

2469
02:06:00,219 --> 02:06:00,553
SUPPORT NEEDS.

2470
02:06:00,553 --> 02:06:08,094
THEY ALSO RECEIVED AT LEAST 1

2471
02:06:08,094 --> 02:06:08,694
ANTIMICROBIAL DRUG AS WELL AND

2472
02:06:08,694 --> 02:06:09,295
ALL THESE CONTRIBUTE DOWN THE

2473
02:06:09,295 --> 02:06:09,929
ROAD TO SIGNIFICANT MORBIDITIES

2474
02:06:09,929 --> 02:06:10,496
FOR THE INFANTS AS WE HEARD

2475
02:06:10,496 --> 02:06:16,736
ABOUT EARLIER.

2476
02:06:16,736 --> 02:06:17,336
WHILE A SERIES OF EVENTS LIKE

2477
02:06:17,336 --> 02:06:17,937
THESE NEED TO BE INVESTIGATED

2478
02:06:17,937 --> 02:06:18,571
FURTHER AND SHOULD NOT BE TAKEN

2479
02:06:18,571 --> 02:06:19,138
LIGHTLY WE HAVE 32 CASES OF

2480
02:06:19,138 --> 02:06:20,539
SEPSIS RELATED TO LBP

2481
02:06:20,539 --> 02:06:25,044
ADMINISTRATION ACCORDING TO

2482
02:06:25,044 --> 02:06:25,578
MEDICAL LITERATURE DESPITE

2483
02:06:25,578 --> 02:06:26,512
HAVING THESE PRODUCTS

2484
02:06:26,512 --> 02:06:30,683
ADMINISTERED WORLDWIDE EVERY DAY

2485
02:06:30,683 --> 02:06:38,324
ON A GIVEN BASIS.

2486
02:06:38,324 --> 02:06:38,924
SO WITH ALL OF THIS IN MIND I

2487
02:06:38,924 --> 02:06:43,629
WANT TO CLOSE BY TAKING A LOOK

2488
02:06:43,629 --> 02:06:44,196
THAT YOU HEARD EARLIER FROM

2489
02:06:44,196 --> 02:06:44,830
DOCTOR PATEL BUT IF YOU LOOK AT

2490
02:06:44,830 --> 02:06:48,901
THE US STARTING WITH THE

2491
02:06:48,901 --> 02:06:49,835
AMERICAN ACADEMY OF PEDIATRICS

2492
02:06:49,835 --> 02:06:54,507
AS A LEADER AND BACK IN 2021 AND

2493
02:06:54,507 --> 02:06:56,175
THEY PUBLISH THEIR STANCE

2494
02:06:56,175 --> 02:06:59,578
CURRENT EVIDENCE WITH UNIVERSAL

2495
02:06:59,578 --> 02:07:05,351
ADMINISTRATION OF PROBIOTICS

2496
02:07:05,351 --> 02:07:05,885
PARTICULARLY THOSE BORN

2497
02:07:05,885 --> 02:07:06,452
EXTREMELY LOW BIRTH WEIGHT.

2498
02:07:06,452 --> 02:07:08,154
WE FOLLOWED THAT WITH THE

2499
02:07:08,154 --> 02:07:12,925
AMERICAN AND GASTRO- SAID

2500
02:07:12,925 --> 02:07:15,428
ASSOCIATION THAT RECOMMENDS

2501
02:07:15,428 --> 02:07:20,433
STRAINS IN COMBINATION FOR USE

2502
02:07:20,433 --> 02:07:21,267
OF PRETERM AND LOW BIRTH WEIGHT

2503
02:07:21,267 --> 02:07:24,036
INFANTS.

2504
02:07:24,036 --> 02:07:27,540
IF WE TRANSITION TO LOOK AT

2505
02:07:27,540 --> 02:07:32,044
INTERNATIONAL ENTITIES THEY

2506
02:07:32,044 --> 02:07:36,482
SUGGEST LBP'S COULD REDUCE RACE

2507
02:07:36,482 --> 02:07:37,016
-- -- RATES OF SEPSIS AND

2508
02:07:37,016 --> 02:07:39,051
MORTALITY BUT CAUTION SHOULD BE

2509
02:07:39,051 --> 02:07:43,622
USED.

2510
02:07:43,622 --> 02:07:45,124
SIMILARLY THE WHO HAS ADDITIONAL

2511
02:07:45,124 --> 02:07:49,495
RECOMMENDATION FOR LBP DUE TO

2512
02:07:49,495 --> 02:07:50,362
THE BALANCE OF EVIDENCE FOR

2513
02:07:50,362 --> 02:07:56,936
DECREASED MORTALITY AND INVASIVE

2514
02:07:56,936 --> 02:07:57,536
INFECTION WITHOUT EVIDENCE OF

2515
02:07:57,536 --> 02:07:58,204
HARM BUT NO RECOMMENDATION WAS

2516
02:07:58,204 --> 02:08:01,440
GIVEN TO THE FORMULATION DOES OR

2517
02:08:01,440 --> 02:08:02,641
TIMING OR DURATION OF USE BUT I

2518
02:08:02,641 --> 02:08:06,145
DO WANT TO HIGHLIGHT THE

2519
02:08:06,145 --> 02:08:07,379
STATEMENT SAYS IT IS ESSENTIAL

2520
02:08:07,379 --> 02:08:10,082
FOR THIS TO BE INCLUDED AS

2521
02:08:10,082 --> 02:08:13,719
SHARED DECISION-MAKING AND THAT

2522
02:08:13,719 --> 02:08:16,255
REQUIRES A NATIONAL REGULATORY

2523
02:08:16,255 --> 02:08:19,391
APPROVAL AND CLEAR INSTRUCTIONS

2524
02:08:19,391 --> 02:08:19,692
FOR SAFETY.

2525
02:08:19,692 --> 02:08:22,328
AS ANYWHERE ELSE IN MEDICINE WE

2526
02:08:22,328 --> 02:08:26,565
NEED TO CARE FOR SUCH A

2527
02:08:26,565 --> 02:08:33,139
VULNERABLE POPULATION.

2528
02:08:33,139 --> 02:08:33,772
AND FINALLY BEFORE I CONCLUDE I

2529
02:08:33,772 --> 02:08:34,340
WANT TO LOOK AT THE CURRENT

2530
02:08:34,340 --> 02:08:39,044
PRACTICES IN THE US AND DOCTOR

2531
02:08:39,044 --> 02:08:39,645
PATEL SPOKE ABOUT THIS EARLIER

2532
02:08:39,645 --> 02:08:41,413
AND I BELIEVE IT IS A DIFFERENT

2533
02:08:41,413 --> 02:08:44,650
STUDY THAT I HAVE HIGHLIGHTED

2534
02:08:44,650 --> 02:08:44,850
HERE.

2535
02:08:44,850 --> 02:08:45,484
ALTHOUGH NOT FORMALLY TRACKED WE

2536
02:08:45,484 --> 02:08:50,222
DO HAVE AN IDEA OF LBP'S AND A

2537
02:08:50,222 --> 02:08:54,627
FEW DIFFERENT ARTICLES.

2538
02:08:54,627 --> 02:09:00,499
SURVEY OF 500 NICU SHOWS TO LOW

2539
02:09:00,499 --> 02:09:01,000
BIRTH WEIGHT INFANTS AND

2540
02:09:01,000 --> 02:09:05,804
REMEMBER THIS IS AROUND THE TIME

2541
02:09:05,804 --> 02:09:06,906
SEVERAL STUDIES STARTED TO SHOW

2542
02:09:06,906 --> 02:09:10,509
THE BENEFIT OF PREVENTING THAT.

2543
02:09:10,509 --> 02:09:11,844
IF WE FAST-FORWARD 2023 AND

2544
02:09:11,844 --> 02:09:17,116
ANOTHER SURVEY SHOWED 29 PERCENT

2545
02:09:17,116 --> 02:09:21,620
ADMINISTERED LBP TO PREMATURE

2546
02:09:21,620 --> 02:09:25,591
NEONATES AND IT WAS REPEATED IN

2547
02:09:25,591 --> 02:09:27,193
2023 AFTER THE PROVIDER LETTERS

2548
02:09:27,193 --> 02:09:36,535
WITH A MUCH LOWER RESPONSE RATE

2549
02:09:36,535 --> 02:09:37,102
THAN THEY DID PREVIOUSLY AND

2550
02:09:37,102 --> 02:09:37,703
ONLY 16 PERCENT OF FACILITIES

2551
02:09:37,703 --> 02:09:38,337
RESPONDED TO THE SECOND SURVEY

2552
02:09:38,337 --> 02:09:42,675
BUT THEY DID FIND ONLY 2 NICU

2553
02:09:42,675 --> 02:09:44,443
RESPONDED WITH CONTINUED USE AND

2554
02:09:44,443 --> 02:09:51,116
IT ALSO FOUND MOST WORD USE FDA

2555
02:09:51,116 --> 02:09:55,454
APPROVED EVEN ONLY BY 10 OR

2556
02:09:55,454 --> 02:09:56,355
20 PERCENT SO SIMILAR TO THE

2557
02:09:56,355 --> 02:10:01,060
LAST SLIDE THEY HIGHLIGHT THERE

2558
02:10:01,060 --> 02:10:07,566
IS A SEVERITY AND THAT THERE IS

2559
02:10:07,566 --> 02:10:08,167
DESPERATION FOR CAREGIVERS AS

2560
02:10:08,167 --> 02:10:08,701
WELL AS FAMILIES TO HAVE A

2561
02:10:08,701 --> 02:10:13,572
SOLUTION FOR THESE PATIENTS.

2562
02:10:13,572 --> 02:10:15,708
SO TO SUMMARIZE LBP'S HAVE

2563
02:10:15,708 --> 02:10:19,445
POTENTIAL BENEFITS REDUCING

2564
02:10:19,445 --> 02:10:26,252
WASTE THE SEPSIS AND PREVENTING

2565
02:10:26,252 --> 02:10:26,819
NEC IN THE HIGHLY VULNERABLE

2566
02:10:26,819 --> 02:10:28,587
POPULATION BUT THE VERDICT IS

2567
02:10:28,587 --> 02:10:31,991
OUT BASED ON THE ORGANISMS THAT

2568
02:10:31,991 --> 02:10:32,625
ARE USED IN THE DOSAGES AND THE

2569
02:10:32,625 --> 02:10:36,095
TIMING AND DURATION LEADING TO

2570
02:10:36,095 --> 02:10:40,165
MULTIPLE AND SOME USE.

2571
02:10:40,165 --> 02:10:41,300
LOOK AT THIS THROUGH THE LENS OF

2572
02:10:41,300 --> 02:10:46,105
PUBLIC HEALTH AND THEN TO

2573
02:10:46,105 --> 02:10:52,511
BALANCE THE RISK OF HARM WHILE

2574
02:10:52,511 --> 02:10:53,145
USING THE PRODUCTS APPROPRIATELY

2575
02:10:53,145 --> 02:10:54,980
AND THIS REQUIRES STANDARDIZING

2576
02:10:54,980 --> 02:10:57,149
RESEARCH PROTOCOLS AND

2577
02:10:57,149 --> 02:10:59,485
MANUFACTURING PRACTICES AS WELL

2578
02:10:59,485 --> 02:11:00,519
AS EQUITABLE USE OF

2579
02:11:00,519 --> 02:11:03,622
INTERVENTIONS.

2580
02:11:03,622 --> 02:11:06,759
FDA APPROVAL OF PRODUCT FIGURES

2581
02:11:06,759 --> 02:11:10,095
PROMINENTLY WITH FORMAL

2582
02:11:10,095 --> 02:11:16,702
RECOMMENDATIONS I'M VERY GLAD WE

2583
02:11:16,702 --> 02:11:17,236
ARE JOINED BY OUR ADVOCACY

2584
02:11:17,236 --> 02:11:17,736
GROUPS AND PROFESSIONAL

2585
02:11:17,736 --> 02:11:21,640
SOCIETIES TO ENSURE FAMILIES ARE

2586
02:11:21,640 --> 02:11:22,107
INVOLVED IN THE SHARED

2587
02:11:22,107 --> 02:11:23,142
DECISION-MAKING OF THE HIGHLY

2588
02:11:23,142 --> 02:11:24,576
VULNERABLE PATIENTS.

2589
02:11:24,576 --> 02:11:27,513
THANK YOU FOR YOUR TIME.

2590
02:11:27,513 --> 02:11:37,690
[APPLAUSE]

2591
02:11:39,491 --> 02:11:40,059
>> WE HAVE A COUPLE OF
QUESTIONS

2592
02:11:40,059 --> 02:11:47,199
IN THE CHAT AND ALSO TO JUST

2593
02:11:47,199 --> 02:11:47,766
SUGGEST YOU DON'T HAVE TO BE

2594
02:11:47,766 --> 02:11:51,370
APPEAR TO ANSWER QUESTIONS IF

2595
02:11:51,370 --> 02:11:51,937
YOU HAVE QUESTIONS TO ANSWER

2596
02:11:51,937 --> 02:12:01,613
JUST OPEN YOUR MIKE.

2597
02:12:01,613 --> 02:12:02,247
>> I SHARE MANY OF THE
THINGS IN

2598
02:12:02,247 --> 02:12:02,848
TERMS OF THE CHALLENGE AND THE

2599
02:12:02,848 --> 02:12:08,320
DIAGNOSIS I THINK SOME OF THOSE

2600
02:12:08,320 --> 02:12:08,821
THAT THE CORE GROUP DID

2601
02:12:08,821 --> 02:12:09,355
HIGHLIGHT GOES TO IMPROVE

2602
02:12:09,355 --> 02:12:11,056
DEFINITION AS WELL AS BIOMARKERS

2603
02:12:11,056 --> 02:12:18,263
TO HELP AID AND DIAGNOSE.

2604
02:12:18,263 --> 02:12:18,864
BUT MY COMMENT IS IF YOU COULD

2605
02:12:18,864 --> 02:12:19,398
ADDRESS THE OBVIOUS ISSUES

2606
02:12:19,398 --> 02:12:22,968
EXCLUDING STAGE I OR LOWER STAGE

2607
02:12:22,968 --> 02:12:23,602
AND THE CHALLENGES VERSUS ENTRY

2608
02:12:23,602 --> 02:12:27,172
AND THE CHALLENGE WHICH IS FOCAL

2609
02:12:27,172 --> 02:12:29,475
INTESTINAL PERFORATION IMPACTS

2610
02:12:29,475 --> 02:12:34,680
LARGELY THE TRIALS AND WHY THAT

2611
02:12:34,680 --> 02:12:40,819
NOISE OR MISCLASSIFICATION MAY

2612
02:12:40,819 --> 02:12:41,220
BIAS THE FINDINGS.

2613
02:12:41,220 --> 02:12:41,854
>> IF YOU ADDRESS THOSE
OBVIOUS

2614
02:12:41,854 --> 02:12:42,488
THINGS AND USE THE APPROACH THAT

2615
02:12:42,488 --> 02:12:51,697
YOU SUBJECTED AND YOU TAKE THIS

2616
02:12:51,697 --> 02:12:52,231
DISEASE THAT IS 5 PERCENT

2617
02:12:52,231 --> 02:12:52,831
BREAKING IT INTO 5 CLUSTERS OF

2618
02:12:52,831 --> 02:12:53,465
1 PERCENT, HOW DO PEOPLE ACHIEVE

2619
02:12:53,465 --> 02:12:53,999
THE TYPES OF TRIALS WE ARE

2620
02:12:53,999 --> 02:12:56,435
ADVOCATING FOR TO MAKE THE'S

2621
02:12:56,435 --> 02:13:00,406
TRIALS THAT ALL OF A SUDDEN

2622
02:13:00,406 --> 02:13:02,608
BECOME VERY CHALLENGING AND

2623
02:13:02,608 --> 02:13:04,743
VISIBLE?

2624
02:13:04,743 --> 02:13:11,917
>> THAT IS STILL TO BE

2625
02:13:11,917 --> 02:13:12,384
DETERMINED OBVIOUSLY.

2626
02:13:12,384 --> 02:13:17,456
BUT THERE ARE SEVERAL ASPECTS OF

2627
02:13:17,456 --> 02:13:21,393
YOUR QUESTION AND 1 IS THAT YOU

2628
02:13:21,393 --> 02:13:23,729
MENTIONED NEC AGAIN AS A

2629
02:13:23,729 --> 02:13:25,697
DISCRETE ENTITY AND THIS IS 1 OF

2630
02:13:25,697 --> 02:13:32,838
THE CONCERNS I HAD ABOUT THAT

2631
02:13:32,838 --> 02:13:33,439
REPORT AND THE EMPHASIS GOING

2632
02:13:33,439 --> 02:13:34,072
FORWARD WITH STUDIES THAT WE ARE

2633
02:13:34,072 --> 02:13:44,616
LOOKING AT 8 DISCRETE ENTITY AT

2634
02:13:45,651 --> 02:13:46,251
LEAST WITH ITS NAME AND WHAT WE

2635
02:13:46,251 --> 02:13:46,885
HAVE TO DO IS MAYBE YOU GET AWAY

2636
02:13:46,885 --> 02:13:47,453
FROM THAT TO TALK ABOUT THE

2637
02:13:47,453 --> 02:13:48,053
DIFFERENT FORMS OF INTESTINAL

2638
02:13:48,053 --> 02:13:51,089
INJURY AND THEN SAY WE WILL

2639
02:13:51,089 --> 02:13:52,090
DISSECT OUT THE DIFFERENT FORMS

2640
02:13:52,090 --> 02:13:54,893
OF INTESTINAL INJURY THAT IS 1

2641
02:13:54,893 --> 02:13:59,431
WAY TO LOOK AT THIS AND THEN

2642
02:13:59,431 --> 02:14:03,969
LOOK AT THE DIFFERENT CLUSTERS.

2643
02:14:03,969 --> 02:14:04,570
WE MAY NOT NEED TO LOOK AT ALL

2644
02:14:04,570 --> 02:14:09,641
OF THESE CLUSTERS BUT IF YOU

2645
02:14:09,641 --> 02:14:12,077
FIND CLUSTERS AND 1 THAT IS VERY

2646
02:14:12,077 --> 02:14:15,681
DANGEROUS WHERE YOU REALLY SEE A

2647
02:14:15,681 --> 02:14:20,552
LOT OF MORTALITY AND MORBID

2648
02:14:20,552 --> 02:14:21,186
MORBIDITY, YOU CAN COMPARE THAT

2649
02:14:21,186 --> 02:14:21,820
TO JUST 1 OTHER CLUSTER AND GET

2650
02:14:21,820 --> 02:14:25,157
A MUCH HIGHER POTENTIAL FOR

2651
02:14:25,157 --> 02:14:26,725
STATISTICALLY SIGNIFICANT

2652
02:14:26,725 --> 02:14:36,869
RESULTS.

2653
02:14:38,837 --> 02:14:39,304
>> THIS IS A COMMENT AND A

2654
02:14:39,304 --> 02:14:39,571
QUESTION.

2655
02:14:39,571 --> 02:14:43,475
WHAT YOU PRESENTED WAS 3

2656
02:14:43,475 --> 02:14:53,852
DIFFERENT SCENARIOS.

2657
02:14:53,852 --> 02:14:54,486
1 IS THAT YOU ARE INFECTED WITH

2658
02:14:54,486 --> 02:14:55,053
WHAT YOU ARE COLONIZED WITH

2659
02:14:55,053 --> 02:14:55,521
THERE IS A PHYSIOLOGIC

2660
02:14:55,521 --> 02:14:56,622
BACKGROUND AND AN OPPORTUNITY

2661
02:14:56,622 --> 02:15:00,125
FOR AN ACTION HEAVILY COLONIZED

2662
02:15:00,125 --> 02:15:03,562
AND THEN THE SECOND SCENARIO AND

2663
02:15:03,562 --> 02:15:08,400
THIRD IS WHAT WE WORRY ABOUT

2664
02:15:08,400 --> 02:15:15,774
THAT LBP HAS PROMOTED THAT THERE

2665
02:15:15,774 --> 02:15:16,375
IS A CONTAMINATION AND THAT IS

2666
02:15:16,375 --> 02:15:21,547
SOMETHING NOT UNIQUE TO LBP SO

2667
02:15:21,547 --> 02:15:23,181
DOES CDC HAVE A PLAN TO PERFORM

2668
02:15:23,181 --> 02:15:25,450
SURVEILLANCE TO LOOK

2669
02:15:25,450 --> 02:15:26,818
PARTICULARLY AT THE SECOND

2670
02:15:26,818 --> 02:15:30,088
SCENARIO WHETHER THERE IS A

2671
02:15:30,088 --> 02:15:32,090
DIFFERENTIAL RISK OF INFECTION

2672
02:15:32,090 --> 02:15:36,562
IF YOU ARE HEAVILY COLONIZED

2673
02:15:36,562 --> 02:15:37,195
WITH THE ADMINISTERED LBP VERSUS

2674
02:15:37,195 --> 02:15:39,131
THE WORLD COLONIZING YOU?

2675
02:15:39,131 --> 02:15:42,334
THAT IS THE KEY QUESTION TO ME.

2676
02:15:42,334 --> 02:15:48,440
>> I STAYED AWAY FROM
TRYING TO

2677
02:15:48,440 --> 02:15:48,974
MAKE CORRELATIONS BETWEEN

2678
02:15:48,974 --> 02:15:54,279
WHETHER OR NOT THE ADMINISTERED

2679
02:15:54,279 --> 02:15:55,047
PROBIOTIC IS THE CAUSE OR JUST

2680
02:15:55,047 --> 02:15:55,480
ASSOCIATED WITH IT.

2681
02:15:55,480 --> 02:16:01,653
I THINK THAT IS STILL A MAJOR

2682
02:16:01,653 --> 02:16:02,287
NEED FOR RESEARCH TO UNDERSTAND

2683
02:16:02,287 --> 02:16:02,921
WHAT THAT TIMING IS OR WHAT THE

2684
02:16:02,921 --> 02:16:06,158
CORRELATION IS.

2685
02:16:06,158 --> 02:16:08,093
IN TERMS OF WHAT CDC HAS DOWN

2686
02:16:08,093 --> 02:16:12,130
THE ROAD IT IS CHALLENGING TO DO

2687
02:16:12,130 --> 02:16:17,336
THIS IN PEDIATRIC HOSPITALS

2688
02:16:17,336 --> 02:16:18,337
THERE MAY BE WAYS TO DO THAT IN

2689
02:16:18,337 --> 02:16:21,540
THE FUTURE AND HEARING WHAT THE

2690
02:16:21,540 --> 02:16:25,811
CONSENSUS IS AS WELL AS WORKING

2691
02:16:25,811 --> 02:16:29,848
TOGETHER WITH FDA AND NIH

2692
02:16:29,848 --> 02:16:30,449
COLLEAGUES CAN HELP DETERMINE

2693
02:16:30,449 --> 02:16:31,850
WHAT THAT CAN BE DOWN THE ROAD

2694
02:16:31,850 --> 02:16:38,357
RIGHT NOW I DON'T KNOW IF WE

2695
02:16:38,357 --> 02:16:38,991
HAVE THE CAPABILITY BUT THAT CAN

2696
02:16:38,991 --> 02:16:40,692
BE SOMETHING TO BUILD ON IN THE

2697
02:16:40,692 --> 02:16:48,100
FUTURE.

2698
02:16:48,100 --> 02:16:58,143
>> JUST 1 QUICK QUESTION.

2699
02:16:58,143 --> 02:16:59,544
HAVE YOU LOOKED AT THE IMMUNE

2700
02:16:59,544 --> 02:17:07,619
SYSTEM MATURITY PRETERM NORMAL

2701
02:17:07,619 --> 02:17:11,556
BASICALLY THE IDEA OF LOOKING AT

2702
02:17:11,556 --> 02:17:12,391
THE IMMUNE SYSTEM DEVELOPMENT AS

2703
02:17:12,391 --> 02:17:16,962
A METRIC?

2704
02:17:16,962 --> 02:17:18,463
>> ABSOLUTELY THERE ARE
BIG

2705
02:17:18,463 --> 02:17:22,768
DIFFERENCES THAT OCCUR IN THE

2706
02:17:22,768 --> 02:17:23,602
INTESTINAL MUCOSAL DURING

2707
02:17:23,602 --> 02:17:29,675
DEVELOPMENT.

2708
02:17:29,675 --> 02:17:31,243
AND IF YOU LOOK AT GOBLET CELLS

2709
02:17:31,243 --> 02:17:35,914
AND MUCUS PRODUCTION AND TINY

2710
02:17:35,914 --> 02:17:36,515
PREMATURE BABIES THERE IS VERY

2711
02:17:36,515 --> 02:17:36,882
LITTLE OF THAT.

2712
02:17:36,882 --> 02:17:39,951
THEY ARE NOT WELL-FORMED THE

2713
02:17:39,951 --> 02:17:42,454
INTESTINAL IGA IS NOT YET

2714
02:17:42,454 --> 02:17:44,423
PRESENT.

2715
02:17:44,423 --> 02:17:51,496
THERE IS NUMEROUS DEVELOPMENTAL

2716
02:17:51,496 --> 02:17:52,064
FACTORS THAT ARE UNDERGOING

2717
02:17:52,064 --> 02:17:52,364
DEVELOPMENT.

2718
02:17:52,364 --> 02:17:56,468
SO THE PRETERM WITH THE MUCOSAL

2719
02:17:56,468 --> 02:17:57,202
IMMUNE SYSTEM ARE HIGHLY

2720
02:17:57,202 --> 02:18:02,507
VULNERABLE.

2721
02:18:02,507 --> 02:18:03,075
SO NOW BETWEEN 1 BABY VERSUS

2722
02:18:03,075 --> 02:18:03,675
ANOTHER THERE IS A HIGH AMOUNT

2723
02:18:03,675 --> 02:18:08,080
OF VARIABILITY BETWEEN BABIES

2724
02:18:08,080 --> 02:18:12,284
AND TO BE ABLE TO DISSECT OUT IN

2725
02:18:12,284 --> 02:18:17,456
ANY GROUPS OF BABIES, THAT WILL

2726
02:18:17,456 --> 02:18:18,090
REQUIRE A LOT OF EFFORT THAT AT

2727
02:18:18,090 --> 02:18:18,724
THIS JUNCTURE WE DON'T HAVE MUCH

2728
02:18:18,724 --> 02:18:21,560
OF THAT.

2729
02:18:21,560 --> 02:18:27,099
PUT TOGETHER THE MICRO BIOME

2730
02:18:27,099 --> 02:18:34,973
THAT IS THE CONCEPT OF THE

2731
02:18:34,973 --> 02:18:35,507
MULTIOMICS AND TYING THEM

2732
02:18:35,507 --> 02:18:36,108
TOGETHER AND INTEGRATING THEM

2733
02:18:36,108 --> 02:18:36,708
THAT WILL BE VERY IMPORTANT IN

2734
02:18:36,708 --> 02:18:37,275
THE FUTURE BUT WE DON'T HAVE

2735
02:18:37,275 --> 02:18:40,345
THAT YET.

2736
02:18:40,345 --> 02:18:46,218
>> WE HAVE 2 MINUTES LEFT.

2737
02:18:46,218 --> 02:18:46,852
>> WITH THE SAFETY
COMPONENTS 1

2738
02:18:46,852 --> 02:18:47,486
OF THE THINGS THAT IS EMERGING

2739
02:18:47,486 --> 02:18:52,624
IS DISCUSSION AROUND MULTI-

2740
02:18:52,624 --> 02:18:53,258
DRUG-RESISTANT ORGANISMS AND THE

2741
02:18:53,258 --> 02:18:53,725
TRANSFER OF ANTIBIOTIC

2742
02:18:53,725 --> 02:18:57,963
RESISTANCE GENES IT COULD GO

2743
02:18:57,963 --> 02:19:01,967
EITHER WAY TO DECREASE THE STUDY

2744
02:19:01,967 --> 02:19:03,335
AND ANY EVIDENCE OF ANTIBIOTIC

2745
02:19:03,335 --> 02:19:06,338
RESISTANCE IN THE REVIEW OF

2746
02:19:06,338 --> 02:19:06,638
LITERATURE?

2747
02:19:06,638 --> 02:19:12,644
>> CAN I CLARIFY YOUR NAME
AND

2748
02:19:12,644 --> 02:19:12,944
ASSOCIATION?

2749
02:19:12,944 --> 02:19:19,618
LBP PROBIOTIC USE.

2750
02:19:19,618 --> 02:19:20,185
I WILL SAY I WAS LOOKING FOR

2751
02:19:20,185 --> 02:19:20,786
THAT AND I DID NOT COME ACROSS

2752
02:19:20,786 --> 02:19:25,590
ANY THAT I WAS ABLE TO IDENTIFY.

2753
02:19:25,590 --> 02:19:26,191
BUT IF OTHERS IN THE AUDIENCE

2754
02:19:26,191 --> 02:19:26,758
HAVE EVIDENCE OTHERWISE I'M

2755
02:19:26,758 --> 02:19:27,159
HAPPY TO HEAR IT.

2756
02:19:27,159 --> 02:19:35,033
TO MY KNOWLEDGE THAT IS A

2757
02:19:35,033 --> 02:19:35,634
THEORETICAL RISK THERE IS THE

2758
02:19:35,634 --> 02:19:36,268
POTENTIAL FOR GENE TRANSFER TO

2759
02:19:36,268 --> 02:19:39,471
ORGANISMS ADMINISTERED THAT

2760
02:19:39,471 --> 02:19:40,038
COULD HAPPEN AT THE TIME OF

2761
02:19:40,038 --> 02:19:43,809
MANUFACTURING OR LATER WHEN THE

2762
02:19:43,809 --> 02:19:45,210
BACTERIA GETS INTO THE

2763
02:19:45,210 --> 02:19:48,046
ENVIRONMENT.

2764
02:19:48,046 --> 02:19:48,680
BUT TO MY KNOWLEDGE AT THIS TIME

2765
02:19:48,680 --> 02:19:59,191
WE HAVE NOT SEEN THAT HAPPEN.

2766
02:20:03,562 --> 02:20:04,129
>> THIS QUESTION IS
DIRECTED AT

2767
02:20:04,129 --> 02:20:04,296
JOE.

2768
02:20:04,296 --> 02:20:06,064
I APPRECIATE THE DISCUSSION

2769
02:20:06,064 --> 02:20:09,534
ABOUT AND TYPING INTESTINAL

2770
02:20:09,534 --> 02:20:10,702
INJURIES.

2771
02:20:10,702 --> 02:20:19,110
DO YOU THINK WE KNOW ENOUGH

2772
02:20:19,110 --> 02:20:19,744
ABOUT THE PATH THE BIOLOGY WITH

2773
02:20:19,744 --> 02:20:20,278
THESE DIFFERENT TYPES TO

2774
02:20:20,278 --> 02:20:21,813
UNDERSTAND IF THERE IS ANY

2775
02:20:21,813 --> 02:20:23,682
OVERLAP OR NO OVERLAP?

2776
02:20:23,682 --> 02:20:29,354
>> THERE -- -- THAT'S A
VERY

2777
02:20:29,354 --> 02:20:29,988
GOOD QUESTION BECAUSE I MAY NOT

2778
02:20:29,988 --> 02:20:30,522
HAVE MADE THAT POINT CLEAR

2779
02:20:30,522 --> 02:20:31,790
ENOUGH.

2780
02:20:31,790 --> 02:20:36,595
THE CLUSTERING WOULD OCCUR FIRST

2781
02:20:36,595 --> 02:20:41,132
AND WE DON'T HAVE THAT YET

2782
02:20:41,132 --> 02:20:41,666
AMONGST SEVERAL DIFFERENT

2783
02:20:41,666 --> 02:20:44,936
NEONATAL INTENSIVE CARE UNITS

2784
02:20:44,936 --> 02:20:46,438
THE NETWORK DOES NOT HAVE THE

2785
02:20:46,438 --> 02:20:51,276
GRANULARITY FROM THE INFORMATION

2786
02:20:51,276 --> 02:20:52,010
I HAVE AVAILABLE FROM THE

2787
02:20:52,010 --> 02:20:54,446
NEONATAL NETWORK TO DO THAT

2788
02:20:54,446 --> 02:20:58,783
TALKING TO THE KOREAN NETWORK

2789
02:20:58,783 --> 02:20:59,417
AND THEY DO HAVE THE GRANULARITY

2790
02:20:59,417 --> 02:21:02,153
TO DO THAT SO WE HAVE STARTED

2791
02:21:02,153 --> 02:21:07,525
WORKING ON GETTING THE DIFFERENT

2792
02:21:07,525 --> 02:21:08,526
CLUSTERS.

2793
02:21:08,526 --> 02:21:16,268
A MUCH LARGER POPULATION.

2794
02:21:16,268 --> 02:21:17,369
>> AND WE CAN START
LOOKING AT

2795
02:21:17,369 --> 02:21:23,508
CLUSTERS.

2796
02:21:23,508 --> 02:21:24,109
>> WE PUT THAT CLUSTER A
WITH

2797
02:21:24,109 --> 02:21:34,519
CLUSTER B AND CLUSTER C.

2798
02:21:35,954 --> 02:21:36,488
>> THAT'S ALL WE HAVE TIME
FOR

2799
02:21:36,488 --> 02:21:37,155
THIS SESSION WE ENCOURAGE YOU TO

2800
02:21:37,155 --> 02:21:38,490
REACH OUT IN PERSON AND ASK

2801
02:21:38,490 --> 02:21:39,557
QUESTIONS.

2802
02:21:39,557 --> 02:21:41,092
NOW WE ARE MOVING INTO THE ORAL

2803
02:21:41,092 --> 02:21:43,094
COMMENTS PERIOD.

2804
02:21:43,094 --> 02:21:47,999
THANK YOU VERY MUCH.

2805
02:21:47,999 --> 02:21:58,209
[APPLAUSE]

2806
02:21:58,209 --> 02:22:00,111
OPEN PUBLIC COMMENTS 1130

2807
02:22:00,111 --> 02:22:04,115
THROUGH 1135 EACH INDIVIDUAL

2808
02:22:04,115 --> 02:22:09,187
WILL HAVE 5 MINUTES TO SPEAK AIR

2809
02:22:09,187 --> 02:22:12,324
IN PRIOR WHO IS REPRESENTING THE

2810
02:22:12,324 --> 02:22:22,567
NEXT SOCIETY.

2811
02:22:25,904 --> 02:22:26,471
>> THANK YOU FOR THE
OPPORTUNITY

2812
02:22:26,471 --> 02:22:27,072
TO SPEAK TODAY IN THE RESEARCH

2813
02:22:27,072 --> 02:22:27,605
DIRECTOR THROUGH THE NEXT

2814
02:22:27,605 --> 02:22:28,173
SOCIETY THE WORLD'S LEADING

2815
02:22:28,173 --> 02:22:28,840
NONPROFIT ORGANIZATION DEDICATED

2816
02:22:28,840 --> 02:22:39,384
TO THE PREVENTION AND TREATMENT

2817
02:22:42,387 --> 02:22:42,854
NECROTIZING ENTEROCOLITIS

2818
02:22:42,854 --> 02:22:43,455
THROUGH RESEARCH AND EDUCATION

2819
02:22:43,455 --> 02:22:43,788
AND ADVOCACY.

2820
02:22:43,788 --> 02:22:44,322
UNDERSTAND THE DEVASTATING

2821
02:22:44,322 --> 02:22:44,923
OUTCOMES THAT RESULT FROM THE

2822
02:22:44,923 --> 02:22:45,557
LACK OF PREVENTION AND TREATMENT

2823
02:22:45,557 --> 02:22:45,924
OPTIONS FOR NEC.

2824
02:22:45,924 --> 02:22:46,558
WE APPRECIATE THE CONVENING AND

2825
02:22:46,558 --> 02:22:47,225
THE RECOGNITION BY THE CDC, FDA

2826
02:22:47,225 --> 02:22:47,792
AND NIH OF THE COMPLEXITIES

2827
02:22:47,792 --> 02:22:53,064
SURROUNDING THE USE FOR THOSE AT

2828
02:22:53,064 --> 02:22:53,598
RISK OF NEC WE SUPPORT THE

2829
02:22:53,598 --> 02:22:54,232
INTENTIONAL FOCUS ON THE SAFETY

2830
02:22:54,232 --> 02:22:54,766
OF THERAPEUTICS FOR THIS

2831
02:22:54,766 --> 02:22:55,633
VULNERABLE POPULATION.

2832
02:22:55,633 --> 02:23:01,606
THE NEXT SOCIETY FOUNDED IN 2014

2833
02:23:01,606 --> 02:23:04,609
AFTER HER SON WAS LOST DUE TO

2834
02:23:04,609 --> 02:23:05,543
COMPLICATIONS BEFORE HIS FIRST

2835
02:23:05,543 --> 02:23:12,283
BIRTHDAY.

2836
02:23:12,283 --> 02:23:12,917
EXPERIENCING A SUDDEN DIAGNOSIS

2837
02:23:12,917 --> 02:23:13,485
THERE WAS LITTLE INFORMATION

2838
02:23:13,485 --> 02:23:13,852
AVAILABLE ON THE

2839
02:23:13,852 --> 02:23:14,452
RISKS, TREATMENTS OR POTENTIAL

2840
02:23:14,452 --> 02:23:17,288
CAUSES OF NEC.

2841
02:23:17,288 --> 02:23:17,856
SHE HAS SINCE HARNESSED AND

2842
02:23:17,856 --> 02:23:18,390
EMPOWERED AN INTERNATIONAL

2843
02:23:18,390 --> 02:23:19,858
NETWORK OF CLINICIANS AND

2844
02:23:19,858 --> 02:23:25,196
SCIENTIST WORKING TOGETHER TO

2845
02:23:25,196 --> 02:23:25,830
BUILD A WORLD WITHOUT THIS CRUEL

2846
02:23:25,830 --> 02:23:26,064
DISEASE.

2847
02:23:26,064 --> 02:23:26,598
THE CURRENT PREVENTION AND

2848
02:23:26,598 --> 02:23:31,436
TREATMENT OPTIONS ARE INADEQUATE

2849
02:23:31,436 --> 02:23:31,970
AND FAILING OUR COMMUNITY.

2850
02:23:31,970 --> 02:23:32,604
ALTHOUGH MORE RESEARCH IS NEEDED

2851
02:23:32,604 --> 02:23:34,439
TO UNDERSTAND AND ELIMINATE NEC

2852
02:23:34,439 --> 02:23:35,940
CURRENT EVIDENCE DEMONSTRATES

2853
02:23:35,940 --> 02:23:38,476
CARE PRACTICES CAN MEANINGFUL

2854
02:23:38,476 --> 02:23:46,684
INFLUENCE MORE SPECIFICALLY

2855
02:23:46,684 --> 02:23:47,218
RESEARCH HAS DEMONSTRATED

2856
02:23:47,218 --> 02:23:47,852
PROBIOTICS COULD BE AN EFFECTIVE

2857
02:23:47,852 --> 02:23:48,453
TOOL TO PREVENT NEC AND DEATH

2858
02:23:48,453 --> 02:23:48,987
AND VERY LOW BIRTH WEIGHT

2859
02:23:48,987 --> 02:23:59,130
INFANTS.

2860
02:24:00,598 --> 02:24:01,166
A NEXUS I DEVELOPED AND RELEASED

2861
02:24:01,166 --> 02:24:01,766
A TOOLKIT A RESOURCE TO BETTER

2862
02:24:01,766 --> 02:24:02,367
UNDERSTAND PROBIOTICS USE AND

2863
02:24:02,367 --> 02:24:02,901
INFORM THE DECISION-MAKING

2864
02:24:02,901 --> 02:24:03,501
PROCESS AND FOSTER DISCUSSION

2865
02:24:03,501 --> 02:24:04,135
AMONG KEY STAKEHOLDERS SPECIFIC

2866
02:24:04,135 --> 02:24:14,579
TO EACH UNIT IT INCLUDES A

2867
02:24:14,879 --> 02:24:15,313
COMPREHENSIVE REVIEW OF

2868
02:24:15,313 --> 02:24:15,880
AVAILABLE EVIDENCE, GUIDANCE

2869
02:24:15,880 --> 02:24:16,448
FROM WORLDWIDE PROFESSIONAL

2870
02:24:16,448 --> 02:24:17,082
ORGANIZATIONS AND TIPS AND TOOLS

2871
02:24:17,082 --> 02:24:17,682
AND MITIGATION STRATEGIES FOR

2872
02:24:17,682 --> 02:24:18,249
HEALTHCARE TEAMS AND PATIENT

2873
02:24:18,249 --> 02:24:18,850
FAMILIES TO NAVIGATE THE RISKS

2874
02:24:18,850 --> 02:24:20,385
AND BENEFITS.

2875
02:24:20,385 --> 02:24:20,985
IN 2023 AS YOU HAVE HEARD

2876
02:24:20,985 --> 02:24:24,522
30 PERCENT OF NICU RAISING

2877
02:24:24,522 --> 02:24:30,361
PROVIDED DASH PROBIOTICS IT IS

2878
02:24:30,361 --> 02:24:30,962
IN, AND MUCH OF THE WORLD BUT

2879
02:24:30,962 --> 02:24:31,596
VIRTUALLY HALTED IN THE US AFTER

2880
02:24:31,596 --> 02:24:32,964
THE FDA WARNING OF THE EXTREMELY

2881
02:24:32,964 --> 02:24:43,308
RARE RISK OF SEPSIS

2882
02:24:49,948 --> 02:24:50,515
COMMUNICATION AND COLLABORATION

2883
02:24:50,515 --> 02:24:51,116
AMONG CLINICIANS AND FAMILIES

2884
02:24:51,116 --> 02:24:51,716
AROUND PROBIOTICS HAVE STOPPED

2885
02:24:51,716 --> 02:24:52,283
BECAUSE THERE ARE NO LONGER

2886
02:24:52,283 --> 02:24:52,684
OPTIONS AVAILABLE.

2887
02:24:52,684 --> 02:24:53,251
IT IS IMPERATIVE WE SUPPORT

2888
02:24:53,251 --> 02:24:53,885
CLINICIANS AND PATIENT FAMILIES

2889
02:24:53,885 --> 02:24:54,486
WORKING IN CONCERT TO EVALUATE

2890
02:24:54,486 --> 02:24:55,019
THE RISKS AND BENEFITS OF

2891
02:24:55,019 --> 02:24:55,587
VARIOUS TREATMENTS INCLUDING

2892
02:24:55,587 --> 02:24:56,554
PROBIOTICS.

2893
02:24:56,554 --> 02:24:57,188
WE MUST HAVE A VOICE OF WHAT IS

2894
02:24:57,188 --> 02:24:57,789
CONSIDERED THE ACCEPTABLE RISK

2895
02:24:57,789 --> 02:24:58,323
OR BENEFIT IN THE NICU AND

2896
02:24:58,323 --> 02:25:08,766
FAMILIES MUST HAVE ACCESS.

2897
02:25:11,102 --> 02:25:11,636
WE CAN WORK SIMULTANEOUSLY AND

2898
02:25:11,636 --> 02:25:12,237
IMPROVE SAFETY AND PREVENTION

2899
02:25:12,237 --> 02:25:12,804
STRATEGIES AS WE DO WITH ALL

2900
02:25:12,804 --> 02:25:13,238
NICU CARE PRACTICES.

2901
02:25:13,238 --> 02:25:13,872
TODAY, RIGHT NOW AS WE HAVE THIS

2902
02:25:13,872 --> 02:25:14,506
MEETING BABIES ARE DYING FROM

2903
02:25:14,506 --> 02:25:20,078
NEC.

2904
02:25:20,078 --> 02:25:20,645
WE HEAR TRAGIC STORIES FROM

2905
02:25:20,645 --> 02:25:21,212
FAMILIES EVERY DAY AS THESE

2906
02:25:21,212 --> 02:25:27,585
DISCUSSIONS REVOLVE AROUND

2907
02:25:27,585 --> 02:25:28,219
PROBIOTIC USE WE NEED A SEAT AT

2908
02:25:28,219 --> 02:25:28,853
THE TABLE WE ARE HERE TO ENGAGE

2909
02:25:28,853 --> 02:25:34,559
IN HAVING A REFINED PATHWAY WITH

2910
02:25:34,559 --> 02:25:35,193
DEMONSTRATED SAFETY OF IMPROVED

2911
02:25:35,193 --> 02:25:35,827
OUTCOMES FOR NEONATES THEY NEED

2912
02:25:35,827 --> 02:25:37,061
MORE INFORMATION HOW THEY CAN

2913
02:25:37,061 --> 02:25:43,568
PROTECT THEIR NEWBORNS HEALTH

2914
02:25:43,568 --> 02:25:44,202
AND THE ABILITY OF CLINICIANS TO

2915
02:25:44,202 --> 02:25:44,836
PROVIDE ACCURATE INFORMATION AND

2916
02:25:44,836 --> 02:25:45,470
DISCUSS PERFECTIVE CARE OPTIONS

2917
02:25:45,470 --> 02:25:46,471
IS BEING HINDERED EVEN SLIGHT

2918
02:25:46,471 --> 02:25:55,346
VARIATIONS TRANSLATE INTO

2919
02:25:55,346 --> 02:25:55,880
PROFOUND CONSEQUENCES FOR

2920
02:25:55,880 --> 02:25:56,514
PATIENT FAMILIES AND CAN BE THE

2921
02:25:56,514 --> 02:25:57,048
DIFFERENCE BETWEEN A CHILD

2922
02:25:57,048 --> 02:25:57,549
DEVELOPING A SEVERE LIFE

2923
02:25:57,549 --> 02:25:58,149
ALTERING OR FATAL DISEASE OR

2924
02:25:58,149 --> 02:25:58,983
GOING AT HOME WITH THEIR

2925
02:25:58,983 --> 02:26:01,686
FAMILY.

2926
02:26:01,686 --> 02:26:04,155
JUST AS HISTORY CHANGING CARE

2927
02:26:04,155 --> 02:26:11,429
PRACTICES IT CARRIES ITS OWN

2928
02:26:11,429 --> 02:26:12,030
RISK OF SUBJECTING PATIENTS TO

2929
02:26:12,030 --> 02:26:12,564
THE DISEASE THAT COULD BE

2930
02:26:12,564 --> 02:26:12,830
PREVENTED.

2931
02:26:12,830 --> 02:26:20,171
CRITICAL TO RECOGNIZE THE

2932
02:26:20,171 --> 02:26:20,738
SHATTERED FAMILIES WHO WILL

2933
02:26:20,738 --> 02:26:21,372
NEVER AGAIN HOLD THEIR CHILDREN

2934
02:26:21,372 --> 02:26:22,006
IN THEIR ARMS AND THE URGENCY OF

2935
02:26:22,006 --> 02:26:22,540
IMPLEMENT TEAM PREVENTION

2936
02:26:22,540 --> 02:26:23,174
STRATEGIES WHILE CONSIDERING THE

2937
02:26:23,174 --> 02:26:23,374
RISKS.

2938
02:26:23,374 --> 02:26:25,143
THANK YOU.

2939
02:26:25,143 --> 02:26:30,648
[APPLAUSE]

2940
02:26:30,648 --> 02:26:33,218
>> THANK YOU WE APPRECIATE
THOSE

2941
02:26:33,218 --> 02:26:35,887
COMMENTS UP NEXT FROM THE

2942
02:26:35,887 --> 02:26:41,092
AMERICAN ACADEMY OF PEDIATRICS.

2943
02:26:41,092 --> 02:26:46,397
>> I WOULD LIKE TO SPEAK.

2944
02:26:46,397 --> 02:26:46,898
I AM IN FULL SUPPORT OF

2945
02:26:46,898 --> 02:26:47,498
EVERYTHING THAT WAS JUST SAID.

2946
02:26:47,498 --> 02:26:57,976
THANK YOU FOR THIS TIME I AM

2947
02:26:58,176 --> 02:26:58,743
SPEAKING TO YOU ON BEHALF OF THE

2948
02:26:58,743 --> 02:26:59,377
AMERICAN ACADEMY OF PEDIATRICS A

2949
02:26:59,377 --> 02:26:59,844
NONPROFIT PROFESSIONAL

2950
02:26:59,844 --> 02:27:00,345
ORGANIZATION OVER 67000

2951
02:27:00,345 --> 02:27:00,945
PEDIATRICIANS COMMITTED TO THE

2952
02:27:00,945 --> 02:27:03,781
OPTIMAL HOPE OF ALL CHILDREN AND

2953
02:27:03,781 --> 02:27:04,415
WE WENT TO ADD HER THANKS TO THE

2954
02:27:04,415 --> 02:27:04,983
ORGANIZERS TO BRING TOGETHER

2955
02:27:04,983 --> 02:27:06,317
IMPORTANT PERSPECTIVES ON THIS

2956
02:27:06,317 --> 02:27:09,787
TOPIC I SERVE AS THE CHAIR OF

2957
02:27:09,787 --> 02:27:10,622
THE AP SECTION THE PROFESSIONAL

2958
02:27:10,622 --> 02:27:13,658
HOME FOR ANY APOLOGIST SENSITIVE

2959
02:27:13,658 --> 02:27:20,565
WARNING WAS ISSUED IN 23 WE HAVE

2960
02:27:20,565 --> 02:27:21,065
HEARD FROM MANY MEMBERS

2961
02:27:21,065 --> 02:27:21,666
REGARDING THE IMPACT OF THEIR

2962
02:27:21,666 --> 02:27:30,341
STATEMENT OF PRETERM INFANTS IS

2963
02:27:30,341 --> 02:27:30,942
3 TUMMY MESSAGES WE WOULD LIKE

2964
02:27:30,942 --> 02:27:31,576
TO SHARE FIRST WE BELIEVE AS WE

2965
02:27:31,576 --> 02:27:32,143
HEARD THERE IS A SUBSTANTIAL

2966
02:27:32,143 --> 02:27:32,610
LIKELIHOOD PROBIOTICS

2967
02:27:32,610 --> 02:27:43,054
CONTRIBUTED TO POSITIVE OUTCOMES

2968
02:27:43,054 --> 02:27:43,655
IN PRETERM INFANTS AND WE WILL

2969
02:27:43,655 --> 02:27:44,255
HEAR MORE THIS AFTERNOON THERE

2970
02:27:44,255 --> 02:27:44,856
ARE MANY REPORTS OF TRIALS AND

2971
02:27:44,856 --> 02:27:45,490
OBSERVATION STUDIES AND ANALYSIS

2972
02:27:45,490 --> 02:27:46,057
EXAMINING PROBIOTICS SEVERAL

2973
02:27:46,057 --> 02:27:46,524
HAVE FOUND SIGNIFICANT

2974
02:27:46,524 --> 02:27:49,594
REDUCTIONS OF NEC AND MORTALITY

2975
02:27:49,594 --> 02:27:50,194
WHILE THE OVERALL CERTAINTY OF

2976
02:27:50,194 --> 02:27:50,828
EVIDENCE IS MIXED IN THE OPTIMAL

2977
02:27:50,828 --> 02:27:51,462
DOSE REMAINS UNDER INVESTIGATION

2978
02:27:51,462 --> 02:27:53,898
THE LIKELIHOOD PROBIOTICS

2979
02:27:53,898 --> 02:27:54,532
CONTRIBUTES TO POSITIVE OUTCOMES

2980
02:27:54,532 --> 02:28:04,742
SEEMS HIGH.

2981
02:28:05,176 --> 02:28:05,743
SECOND AP POLICIES SUPPORTS THE

2982
02:28:05,743 --> 02:28:06,344
USE OF PROBIOTICS FOR PRETERM

2983
02:28:06,344 --> 02:28:06,944
ELEMENTS WITH THE ELEMENTS OF

2984
02:28:06,944 --> 02:28:08,246
THE 2021 AP POLICY STATEMENT HAS

2985
02:28:08,246 --> 02:28:12,183
IT LISTED ALREADY BUT THE 2023

2986
02:28:12,183 --> 02:28:16,754
MORNING LEAVES THE MISS

2987
02:28:16,754 --> 02:28:17,355
IMPRESSION IT OPPOSES ALL USE

2988
02:28:17,355 --> 02:28:27,865
WHILE THE WARNING HIGHLIGHTED

2989
02:28:29,033 --> 02:28:29,534
THE CONCLUSION THAT "CURRENT

2990
02:28:29,534 --> 02:28:30,134
EVIDENCE DOES NOT SUPPORT THE

2991
02:28:30,134 --> 02:28:30,768
ROUTINE UNIVERSAL ADMINISTRATION

2992
02:28:30,768 --> 02:28:31,302
OF PROBIOTICS FOR PRETERM

2993
02:28:31,302 --> 02:28:31,869
INFANTS"IT DOES NOT ADDRESS

2994
02:28:31,869 --> 02:28:32,437
OTHER KEY COMPONENTS OF THE

2995
02:28:32,437 --> 02:28:42,880
STATEMENT FROM AS WE HEARD

2996
02:28:47,118 --> 02:28:47,652
EARLIER AND ACKNOWLEDGES THAT

2997
02:28:47,652 --> 02:28:48,186
SOME CENTERS MAY CHOOSE TO

2998
02:28:48,186 --> 02:28:48,820
ADMINISTER PROBIOTICS AND OFFERS

2999
02:28:48,820 --> 02:28:49,387
GUIDANCE HOW IT CAN BE DONE

3000
02:28:49,387 --> 02:28:49,721
APPROPRIATELY.

3001
02:28:49,721 --> 02:28:50,355
IT INCLUDES DISCUSSION OF RISKS

3002
02:28:50,355 --> 02:28:50,888
AND BENEFITS FOR FAMILIES

3003
02:28:50,888 --> 02:28:51,422
CONSIDERATION OF INFORMED

3004
02:28:51,422 --> 02:28:52,023
CONSENT AND CAREFUL MONITORING

3005
02:28:52,023 --> 02:28:52,824
OF OUTCOMES AND ADVERSE EVENTS.

3006
02:28:52,824 --> 02:28:53,324
LASTLY AS WE HAVE HEARD

3007
02:28:53,324 --> 02:28:54,192
PROBIOTIC USE IN THE NICU HAS

3008
02:28:54,192 --> 02:28:56,227
PRECIPITOUSLY DECLINED SINCE THE

3009
02:28:56,227 --> 02:29:01,666
FDA WARNING.

3010
02:29:01,666 --> 02:29:02,300
THERE ARE OTHER REPORTS WE HAVE

3011
02:29:02,300 --> 02:29:06,337
SEEN INDICATE BY 1 THIRD OF NICU

3012
02:29:06,337 --> 02:29:08,940
USING PROBIOTICS A SIMILAR

3013
02:29:08,940 --> 02:29:12,810
SURVEY CONDUCTED THIS MONTH IS

3014
02:29:12,810 --> 02:29:19,984
DIFFERENT SHOWN PROBIOTIC USE

3015
02:29:19,984 --> 02:29:20,618
HAD ALMOST STOPPED IN ALL CASES

3016
02:29:20,618 --> 02:29:21,219
THE DECISION TO STOP PROBIOTIC

3017
02:29:21,219 --> 02:29:23,755
USE IS BASED ON THE FDA WARNING.

3018
02:29:23,755 --> 02:29:24,722
ESTIMATED IT HAS BEEN CLEAR NOT

3019
02:29:24,722 --> 02:29:29,927
TO INSTRUCT CARE IN PRETERM

3020
02:29:29,927 --> 02:29:33,598
OFFENSE BUT THE RESULT HAS BEEN

3021
02:29:33,598 --> 02:29:34,232
A LARGE REDUCTION OF THE USE OF

3022
02:29:34,232 --> 02:29:43,975
PROBIOTICS IN THE NICU.

3023
02:29:43,975 --> 02:29:44,575
WE RESPECT AND APPRECIATE THE

3024
02:29:44,575 --> 02:29:45,109
REGULATORY OVERSIGHT OVER

3025
02:29:45,109 --> 02:29:45,743
DIETARY SUPPLEMENTS AND WE KNOW

3026
02:29:45,743 --> 02:29:46,377
THE SUPERVISION IS ESSENTIAL FOR

3027
02:29:46,377 --> 02:29:46,978
SAFE HEALTHCARE IN THE UNITED

3028
02:29:46,978 --> 02:29:47,211
STATES.

3029
02:29:47,211 --> 02:29:50,948
HOWEVER NEONATOLOGIST ARE

3030
02:29:50,948 --> 02:29:51,582
STRUGGLING WITH THIS ISSUE WITH

3031
02:29:51,582 --> 02:29:52,250
THE CURRENT REGULATORY AND LEGAL

3032
02:29:52,250 --> 02:29:58,356
UNCERTAINTY MOREOVER WE ARE

3033
02:29:58,356 --> 02:29:58,890
CONCERNED THE WARNING HAS

3034
02:29:58,890 --> 02:29:59,524
NEGATIVELY IMPACTED THE PRACTICE

3035
02:29:59,524 --> 02:30:00,691
OF MEDICINE AND MAY ADVERSELY

3036
02:30:00,691 --> 02:30:04,429
IMPACT OF PRETERM INFANTS.

3037
02:30:04,429 --> 02:30:10,134
FIRST AS IS DOING WE ASK FEDERAL

3038
02:30:10,134 --> 02:30:10,701
HEALTH AGENCIES TO EXTRADITE

3039
02:30:10,701 --> 02:30:11,202
STEPS NEEDED TO PERFORM

3040
02:30:11,202 --> 02:30:13,004
EVALUATION FOR PROBIOTICS FOR

3041
02:30:13,004 --> 02:30:15,306
PRETERM INFANTS.

3042
02:30:15,306 --> 02:30:18,676
THE IT INDICATES TO MITIGATE

3043
02:30:18,676 --> 02:30:20,845
CURE OR PREVENT A DISEASE OR

3044
02:30:20,845 --> 02:30:23,781
CONDITION SUCH AS NEC WITH AN

3045
02:30:23,781 --> 02:30:25,283
INVESTIGATIONAL NEW DRUG

3046
02:30:25,283 --> 02:30:29,720
APPLICATION AND ALSO TO PURSUE

3047
02:30:29,720 --> 02:30:32,323
THE IND IS NOT REALISTIC FOR

3048
02:30:32,323 --> 02:30:38,095
MEMBERS WE URGE THE FDA AND

3049
02:30:38,095 --> 02:30:38,596
OTHERS TO WORK WITH THE

3050
02:30:38,596 --> 02:30:39,096
SCIENTIFIC COMMUNITY AND

3051
02:30:39,096 --> 02:30:40,164
MANUFACTURERS TO EXPEDITE TRIALS

3052
02:30:40,164 --> 02:30:43,935
AS MUCH AS POSSIBLE.

3053
02:30:43,935 --> 02:30:47,472
PERHAPS SCIENCE CAN BE USED TO

3054
02:30:47,472 --> 02:30:50,441
FACILITATE THE PARTICIPATION IN

3055
02:30:50,441 --> 02:30:50,975
WITH NEEDED EVIDENCE MORE

3056
02:30:50,975 --> 02:30:57,849
QUICKLY.

3057
02:30:57,849 --> 02:30:58,483
SECOND WE ENCOURAGE THE FDA TO

3058
02:30:58,483 --> 02:30:59,116
EXERCISE ENFORCEMENT DISCRETION

3059
02:30:59,116 --> 02:31:00,384
TO ALLOW INDIVIDUAL CLINICIANS

3060
02:31:00,384 --> 02:31:09,527
IN PRETERM INFANTS IT IS BASED

3061
02:31:09,527 --> 02:31:10,161
IN PART ON THE PERCEIVED USE OF

3062
02:31:10,161 --> 02:31:10,761
PROBIOTICS WITH THE INTENT TO

3063
02:31:10,761 --> 02:31:11,329
MITIGATE THE USE UP HOWEVER

3064
02:31:11,329 --> 02:31:12,196
THERE ARE MANY REASONS PROVIDERS

3065
02:31:12,196 --> 02:31:15,833
INCLUDING REDUCING MORTALITY

3066
02:31:15,833 --> 02:31:20,671
REDUCING DURATION.

3067
02:31:20,671 --> 02:31:21,672
THE AP REPORT FROM 2021 HAS

3068
02:31:21,672 --> 02:31:26,444
DETAILED GUIDANCE FOR PRETERM

3069
02:31:26,444 --> 02:31:31,415
INFANTS AND IT COULD BE A

3070
02:31:31,415 --> 02:31:31,983
CRITERIA UNDER WHICH THE FDA

3071
02:31:31,983 --> 02:31:32,483
COULD ALLOW ENFORCEMENT

3072
02:31:32,483 --> 02:31:32,783
FLEXIBILITY.

3073
02:31:32,783 --> 02:31:34,051
WE ARE CONCERNED WITHOUT THIS TO

3074
02:31:34,051 --> 02:31:36,187
REDUCE THE BURDEN OF SERIOUS

3075
02:31:36,187 --> 02:31:41,893
OUTCOMES WOULD BE HAMPERED WITH

3076
02:31:41,893 --> 02:31:43,327
THE OFFICIAL POLICY ALLOWING THE

3077
02:31:43,327 --> 02:31:47,031
USE OF PROBIOTICS FOR THE

3078
02:31:47,031 --> 02:31:47,565
PROMOTION OVERALL HEALTH.

3079
02:31:47,565 --> 02:31:49,534
THANK YOU FOR HOLDING THE

3080
02:31:49,534 --> 02:31:55,773
MEETING.

3081
02:31:55,773 --> 02:32:03,214
[APPLAUSE]

3082
02:32:03,214 --> 02:32:13,291
>> .

3083
02:32:13,724 --> 02:32:24,135
>> GRATEFUL FOR THE
COMMENTS

3084
02:32:30,274 --> 02:32:30,841
THAT WE WERE HEARING BEFORE FROM

3085
02:32:30,841 --> 02:32:31,375
THE SPEAKERS PROFESSIONAL

3086
02:32:31,375 --> 02:32:32,009
CONFLICT OF INTEREST BUT I WILL

3087
02:32:32,009 --> 02:32:32,610
BE DISCUSSING PROBIOTICS THAT

3088
02:32:32,610 --> 02:32:33,244
ARE NOT APPROVED AS A MEDICATION

3089
02:32:33,244 --> 02:32:33,544
BY THE FDA.

3090
02:32:33,544 --> 02:32:34,178
SO WITH SOME CONTACT THE MEDICAL

3091
02:32:34,178 --> 02:32:34,779
GROUP IS AFFILIATED PHYSICIANS

3092
02:32:34,779 --> 02:32:37,448
WITH A LARGE FOOTPRINT IN

3093
02:32:37,448 --> 02:32:47,692
NEONATOLOGIST.

3094
02:32:52,563 --> 02:32:52,997
WE MADE FROM ACCUSED TO

3095
02:32:52,997 --> 02:32:53,564
CHILDREN'S HOSPITAL 100,000

3096
02:32:53,564 --> 02:32:58,569
BABIES PER YEAR AND WE HAVE 5500

3097
02:32:58,569 --> 02:33:00,137
BABIES AND THAT IS ABOUT ROUGHLY

3098
02:33:00,137 --> 02:33:01,739
20 PERCENT OF US NEONATOLOGY AND

3099
02:33:01,739 --> 02:33:08,679
THE GOOD NEWS IS THAT IS FED

3100
02:33:08,679 --> 02:33:09,046
INTO A DATA SET.

3101
02:33:09,046 --> 02:33:09,680
IT'S NOT PERFECT BUT ALLOW SOME

3102
02:33:09,680 --> 02:33:11,082
UNIQUE HERE NEED -- -- LEARNING

3103
02:33:11,082 --> 02:33:14,619
FROM THE NEONATAL CONSORTIUM

3104
02:33:14,619 --> 02:33:15,219
EACH WITH DIFFERENT STRENGTHS

3105
02:33:15,219 --> 02:33:22,593
AND WEAKNESSES.

3106
02:33:22,593 --> 02:33:23,160
SO OUR AFFILIATED PHYSICIANS

3107
02:33:23,160 --> 02:33:23,794
RESPECT THE WORK OF THE FDA AND

3108
02:33:23,794 --> 02:33:25,162
CHAIR -- -- SHARE THE WARNING

3109
02:33:25,162 --> 02:33:26,897
LETTER REGARDING USE OF

3110
02:33:26,897 --> 02:33:28,199
PROBIOTICS WITH AFFILIATED

3111
02:33:28,199 --> 02:33:32,937
CLINICIANS WE VIEW NEC HAS A

3112
02:33:32,937 --> 02:33:34,505
DREADED COMPLICATION OF

3113
02:33:34,505 --> 02:33:38,976
PREMATURITY THAT IS MORE

3114
02:33:38,976 --> 02:33:39,543
APPROPRIATELY TERMED DISEASE

3115
02:33:39,543 --> 02:33:41,412
THAT IS NOT BETTER UNDERSTOOD

3116
02:33:41,412 --> 02:33:42,446
THAT HAS NEED TREATMENTS AND

3117
02:33:42,446 --> 02:33:45,416
PREVENTATIVE MEASURES.

3118
02:33:45,416 --> 02:33:49,353
WE HAVE COLLABORATED PREVIOUSLY

3119
02:33:49,353 --> 02:33:50,554
AND WE COMMIT TO COLLABORATE

3120
02:33:50,554 --> 02:33:53,457
GOING FORWARD.

3121
02:33:53,457 --> 02:33:59,463
SO TO GIVE SOME PEDIATRIX IS 1

3122
02:33:59,463 --> 02:34:02,867
OF THE LARGEST DATA SETS IN THE

3123
02:34:02,867 --> 02:34:04,535
WORLD AND INCLUDING 20

3124
02:34:04,535 --> 02:34:12,376
SPECIFICALLY RELATED TO NEC

3125
02:34:12,376 --> 02:34:12,777
AND/OR PROBIOTICS.

3126
02:34:12,777 --> 02:34:13,377
HAVE TIME TO GO THROUGH THESE

3127
02:34:13,377 --> 02:34:13,844
BUT A COUPLE HAVE BEEN

3128
02:34:13,844 --> 02:34:14,111
MENTIONED.

3129
02:34:14,111 --> 02:34:16,080
SO WHAT ARE WE SEEING?

3130
02:34:16,080 --> 02:34:19,817
PROBIOTIC USE WAS INCREASING

3131
02:34:19,817 --> 02:34:20,418
PRIOR TO THE WARNING LETTER

3132
02:34:20,418 --> 02:34:24,722
ABOUT 1 THIRD OF VLBW INFANTS IN

3133
02:34:24,722 --> 02:34:26,023
THE NETWORK WERE RECEIVING

3134
02:34:26,023 --> 02:34:31,162
PROBIOTICS SO ABOUT 2 THIRDS AND

3135
02:34:31,162 --> 02:34:31,729
MORE THAN 50 PERCENT OF THE

3136
02:34:31,729 --> 02:34:37,234
UNITS WERE NOT USING PROBIOTICS

3137
02:34:37,234 --> 02:34:37,868
BUT A SIGNIFICANT PROPORTION OF

3138
02:34:37,868 --> 02:34:38,803
THE BABIES WERE BUT THE WARNING

3139
02:34:38,803 --> 02:34:45,843
LETTER CAME OUT BUT OUR BABIES

3140
02:34:45,843 --> 02:34:46,477
ARE CAPTURED ON DISCHARGE DAY SO

3141
02:34:46,477 --> 02:34:47,178
THOSE BORN IN THESE QUARTERS ARE

3142
02:34:47,178 --> 02:34:48,546
NOT DISCHARGED UNTIL THE

3143
02:34:48,546 --> 02:34:49,513
SUBSEQUENT QUARTER AFTER THE

3144
02:34:49,513 --> 02:34:52,083
WARNING LETTER BUT THE SPIGOT

3145
02:34:52,083 --> 02:34:54,685
HAS BEEN TURNED OFF.

3146
02:34:54,685 --> 02:34:57,488
1 OF THE CONCERNS THAT BROUGHT

3147
02:34:57,488 --> 02:35:00,458
FORTH IN THE WARNING LETTER IF

3148
02:35:00,458 --> 02:35:03,494
WE LOOK IN OUR NETWORK AT 29

3149
02:35:03,494 --> 02:35:06,864
WEEKS GESTATION BABIES OVER A 6

3150
02:35:06,864 --> 02:35:13,037
YEAR WINDOW A LITTLE OVER 9000

3151
02:35:13,037 --> 02:35:13,604
BABIES EXPOSED TO PROBIOTICS

3152
02:35:13,604 --> 02:35:15,673
WITH 11 DOCUMENTED INFECTIONS

3153
02:35:15,673 --> 02:35:20,077
WITH BLOOD OF THE SPINAL FLUID.

3154
02:35:20,077 --> 02:35:22,780
AND INTO OF THOSE THEY WERE

3155
02:35:22,780 --> 02:35:25,182
REPORTED AS CONTAMINANT POSSIBLY

3156
02:35:25,182 --> 02:35:26,751
A FALSE POSITIVE AND IN 9

3157
02:35:26,751 --> 02:35:30,421
PATIENTS POSSIBLY A TRUE

3158
02:35:30,421 --> 02:35:31,355
INFECTION 7 DISCHARGE HOME 1

3159
02:35:31,355 --> 02:35:38,195
TRANSFERRED TO ANOTHER HOSPITAL

3160
02:35:38,195 --> 02:35:38,729
AND IS UNKNOWN AND 1 DIED

3161
02:35:38,729 --> 02:35:39,296
APPROXIMATELY 40 DAYS LATER.

3162
02:35:39,296 --> 02:35:40,364
IS NOT CLEAR THE ATTRIBUTION OF

3163
02:35:40,364 --> 02:35:44,935
DEATH FROM OUR DATA SET.

3164
02:35:44,935 --> 02:35:47,438
WHEN WE LOOK AT JUST NEC AND

3165
02:35:47,438 --> 02:35:51,642
MORTALITY THOSE BORN IN THE SAME

3166
02:35:51,642 --> 02:35:57,882
6 YEAR WINDOW IT IS 44000 BABIES

3167
02:35:57,882 --> 02:35:58,516
ABOUT 1854 WERE DIAGNOSED AT 4.2

3168
02:35:58,516 --> 02:36:02,520
PERCENT A LITTLE OVER 1000 THOSE

3169
02:36:02,520 --> 02:36:04,121
THAT WERE DIAGNOSED WITH MEDICAL

3170
02:36:04,121 --> 02:36:07,825
NEC AS THE THE DIAGNOSIS CAN BE

3171
02:36:07,825 --> 02:36:14,498
COMPLICATED I KNOW 139 OR

3172
02:36:14,498 --> 02:36:15,065
13 PERCENT DIED AND THAT IS

3173
02:36:15,065 --> 02:36:15,633
SLIGHTLY A UNDERESTIMATE AS

3174
02:36:15,633 --> 02:36:20,137
ALMOST 1 THIRD WAS IN THE BIRTH

3175
02:36:20,137 --> 02:36:20,638
HOSPITAL SENT TO ANOTHER

3176
02:36:20,638 --> 02:36:21,806
INSTITUTION FOR HIGHER LEVEL OF

3177
02:36:21,806 --> 02:36:22,940
CARE.

3178
02:36:22,940 --> 02:36:27,645
LOOK AT THOSE WITH SURGICAL NEC

3179
02:36:27,645 --> 02:36:36,353
AND 44 PERCENT DIED WHICH IS

3180
02:36:36,353 --> 02:36:36,987
LIKELY IN UNDERESTIMATE AS THEY

3181
02:36:36,987 --> 02:36:37,555
WERE TRANSFERRED ELSEWHERE.

3182
02:36:37,555 --> 02:36:38,956
JUST LOOKING AT ALL DEATHS OF

3183
02:36:38,956 --> 02:36:41,659
BABIES NOT JUST NEC RELATED THAT

3184
02:36:41,659 --> 02:36:44,094
IS 5098 DEATHS AND 9.4 PERCENT

3185
02:36:44,094 --> 02:36:49,233
WERE BABIES THAT HAD NEC MEDICAL

3186
02:36:49,233 --> 02:36:50,234
OR SURGICAL AND I AM REMISS TO

3187
02:36:50,234 --> 02:36:55,673
TALK ABOUT AND VALUES HERE THOSE

3188
02:36:55,673 --> 02:36:56,307
ARE REAL HUMAN BABIES IF YOU ARE

3189
02:36:56,307 --> 02:36:56,874
CLINICIAN THAT WORKS ON THE

3190
02:36:56,874 --> 02:37:04,515
FRONT AND THESE ARE

3191
02:37:04,515 --> 02:37:05,149
HEARTBREAKING BECAUSE OFTEN THEY

3192
02:37:05,149 --> 02:37:05,783
HAVE GOTTEN THROUGH MANY OF THE

3193
02:37:05,783 --> 02:37:06,350
SCARY THINGS IN THEIR EARLY

3194
02:37:06,350 --> 02:37:08,352
COURSE ONLY TO BE SNAKE BIT BY

3195
02:37:08,352 --> 02:37:12,590
THE TERRIBLE DISEASE.

3196
02:37:12,590 --> 02:37:13,224
SO TO SHORT COMMENTS WE ANALYZE

3197
02:37:13,224 --> 02:37:18,562
THE IMPACT OF THE CESSATION OF

3198
02:37:18,562 --> 02:37:19,196
PROBIOTIC USE OF HEALTH OUTCOMES

3199
02:37:19,196 --> 02:37:24,335
OF HIGH RISK PRETERM IN SINCE

3200
02:37:24,335 --> 02:37:24,935
IT'S TOO EARLY TO LOOK AT THAT

3201
02:37:24,935 --> 02:37:25,870
ASSOCIATION YET AND THE LINE OF

3202
02:37:25,870 --> 02:37:28,105
DEMARCATION SEEKING TO MITIGATE

3203
02:37:28,105 --> 02:37:36,347
OR TREAT DISEASE IS MURKY.

3204
02:37:36,347 --> 02:37:36,814
SO WHAT CAN BE DONE TO

3205
02:37:36,814 --> 02:37:37,414
FACILITATE CLINICAL TRIALS IN

3206
02:37:37,414 --> 02:37:37,948
THIS AREA AND YOU SEEK TO

3207
02:37:37,948 --> 02:37:38,949
REGULATE OTHER NUTRITIONAL

3208
02:37:38,949 --> 02:37:41,619
PRODUCTS USED IN THE NICU

3209
02:37:41,619 --> 02:37:43,254
SIMILAR FOR USE OF PROBIOTICS?

3210
02:37:43,254 --> 02:37:53,664
THANK YOU FOR HAVING ME.

3211
02:37:53,898 --> 02:37:54,365
>> THANK YOU FROM ALL THE

3212
02:37:54,365 --> 02:37:55,399
SPEAKERS FROM THE 2 SESSIONS I

3213
02:37:55,399 --> 02:38:01,672
APPRECIATE YOU SHARING YOUR

3214
02:38:01,672 --> 02:38:02,306
THOUGHTS AND BEING ON TIME ALSO

3215
02:38:02,306 --> 02:38:02,907
THANK YOU TO THE 3 MEMBERS OF

3216
02:38:02,907 --> 02:38:04,074
THE PUBLIC TO SHARE THEIR

3217
02:38:04,074 --> 02:38:14,251
THOUGHTS.

3218
02:38:22,092 --> 02:38:22,660
WE WILL ADJOURN UNTIL 1:00 P.M.

3219
02:38:22,660 --> 02:38:23,294
I WILL MEET YOU HERE AT 1:00 WE

3220
02:38:23,294 --> 02:38:23,827
HAVE LUNCH BREAK 1 HOUR 15

3221
02:38:23,827 --> 02:38:24,461
MINUTES IF YOU PURCHASED A LUNCH

3222
02:38:24,461 --> 02:38:25,029
STRAIGHT THROUGH THE DOUBLE

3223
02:38:25,029 --> 02:38:25,429
DOORS AND INTO THE

3224
02:38:25,429 --> 02:38:25,963
NONFUNCTIONING CAFETERIA.

3225
02:38:25,963 --> 02:38:26,563
YOU'RE MORE THAN WELCOME THERE

3226
02:38:26,563 --> 02:38:27,231
IS SEATING THERE ALSO OUTSIDE IF

3227
02:38:27,231 --> 02:38:27,798
YOU DID NOT OR DON'T HAVE A

3228
02:38:27,798 --> 02:38:28,399
LUNCH THERE ARE LUNCH OPTIONS

3229
02:38:28,399 --> 02:38:33,671
OUT THE FRONT DOOR OUT THE LIGHT

3230
02:38:33,671 --> 02:38:34,305
PASS A LIGHT MAKE SURE YOU TAKE

3231
02:38:34,305 --> 02:38:34,972
YOUR BADGE OTHERWISE YOU WILL

3232
02:38:34,972 --> 02:38:37,541
NOT COME BACK IN.

3233
02:38:37,541 --> 02:38:39,143
WE WILL SEE YOU HERE AT 1:00

3234
02:38:39,143 --> 02:38:39,310
P.M.

3235
02:38:39,310 --> 02:38:44,382
THANK YOU.

3236
02:39:25,865 --> 02:39:26,399
>> THANK YOU TO THE
ORGANIZERS

3237
02:39:26,399 --> 02:39:28,234
AS A FASCINATING AND CHALLENGING

3238
02:39:28,234 --> 02:39:30,603
TOPIC.

3239
02:39:30,603 --> 02:39:34,740
I'M HAPPY TO HAVE THESE IN-DEPTH

3240
02:39:34,740 --> 02:39:35,775
DISCUSSIONS STARTING LONG

3241
02:39:35,775 --> 02:39:39,445
COLLABORATIONS.

3242
02:39:39,445 --> 02:39:39,812
NO DISCLOSURES.

3243
02:39:39,812 --> 02:39:42,548
THE WORKER WILL PRESENT HAS BEEN

3244
02:39:42,548 --> 02:39:46,719
FUNDED BY NIAID.

3245
02:39:46,719 --> 02:39:50,957
I AM THE CHAIR OF THE AGA

3246
02:39:50,957 --> 02:39:56,929
SCIENTIFIC ADVISORY BOARD FOR

3247
02:39:56,929 --> 02:39:57,563
THEIR MICRO BIOME CENTER BUT ALL

3248
02:39:57,563 --> 02:39:58,130
OF MY DISCUSSIONS ARE MY OWN

3249
02:39:58,130 --> 02:40:04,470
PERSONAL OPINION AND NO OTHER

3250
02:40:04,470 --> 02:40:11,410
FINANCIAL SUPPORT.

3251
02:40:11,410 --> 02:40:12,044
SO WE ALL KNOW WHAT THE PROBLEM

3252
02:40:12,044 --> 02:40:22,221
IS BY NOW.

3253
02:40:23,189 --> 02:40:23,656
NECROTIZING ENTEROCOLITIS

3254
02:40:23,656 --> 02:40:24,223
UTTERLY CATASTROPHIC ILLNESS

3255
02:40:24,223 --> 02:40:24,857
DISPROPORTIONATELY WITH CHILDREN

3256
02:40:24,857 --> 02:40:25,458
BORN LESS THAN 1500 GRAMS AND

3257
02:40:25,458 --> 02:40:26,092
AFFECTED MORE SEVERELY WEIGHING

3258
02:40:26,092 --> 02:40:33,833
LESS THAN 1000 GRAMS.

3259
02:40:33,833 --> 02:40:34,500
THEY ARE UNIQUELY SUSCEPTIBLE TO

3260
02:40:34,500 --> 02:40:35,067
DISEASES OF GOT ORIGIN QUITE

3261
02:40:35,067 --> 02:40:43,609
LIKELY MICROBIAL THAT HAS BEEN

3262
02:40:43,609 --> 02:40:44,210
PRECIPITATED OR PERPETUATED IN

3263
02:40:44,210 --> 02:40:44,844
THIS TALK I WOULD LIKE TO TOUCH

3264
02:40:44,844 --> 02:40:46,045
ON SEVERAL POINTS HOW GET

3265
02:40:46,045 --> 02:40:51,417
MICROBIAL OPTIONS CHANGE OVER

3266
02:40:51,417 --> 02:40:51,984
TIME AND TRY TO LOOK AT WHAT

3267
02:40:51,984 --> 02:40:52,618
MIGHT DRIVE SOME OF THESE

3268
02:40:52,618 --> 02:40:56,389
COMPOSITIONAL CHANGES.

3269
02:40:56,389 --> 02:40:56,889
TRY TO THE TERM IN SOME

3270
02:40:56,889 --> 02:40:59,558
LITERATURE OUT THERE AND SOME

3271
02:40:59,558 --> 02:41:03,763
COHORT STUDIES LINKING WHAT IS

3272
02:41:03,763 --> 02:41:04,797
IN THE GUT OR THE MICROBES IN

3273
02:41:04,797 --> 02:41:10,236
THE GUT OR THE DISEASE IS INPUT

3274
02:41:10,236 --> 02:41:10,669
TOGETHER NECROTIZING

3275
02:41:10,669 --> 02:41:13,739
ENTEROCOLITIS AND EXPLORING

3276
02:41:13,739 --> 02:41:18,878
KNOWLEDGE OF GUT MICROBES TO BE

3277
02:41:18,878 --> 02:41:19,712
HARNESSED WITH ENDPOINTS FOR

3278
02:41:19,712 --> 02:41:22,848
STUDIES.

3279
02:41:22,848 --> 02:41:25,117
AND WITH THAT I WILL GO INTO

3280
02:41:25,117 --> 02:41:27,353
THIS AS WE ALL HAVE LEARNED AS

3281
02:41:27,353 --> 02:41:34,627
THE TEMPORARY INTEREST TO BE

3282
02:41:34,627 --> 02:41:35,261
COLONIZED PRENATALLY THE GUT THE

3283
02:41:35,261 --> 02:41:36,128
CHILDREN ARE BORN WITH STERILE

3284
02:41:36,128 --> 02:41:38,664
INTESTINES ALMOST NO EVIDENCE OF

3285
02:41:38,664 --> 02:41:42,768
VIABILITY OF MICROBES IN INFANT

3286
02:41:42,768 --> 02:41:44,136
GETS.

3287
02:41:44,136 --> 02:41:49,375
SOON AFTER BIRTH THE MECONIUM

3288
02:41:49,375 --> 02:41:54,547
WILL PASS OUT AND THE HUMAN

3289
02:41:54,547 --> 02:41:57,583
BEGINS A LIFELONG CONNECTION TO

3290
02:41:57,583 --> 02:42:00,019
MICROBES OF DIVERSE CONSTITUENCY

3291
02:42:00,019 --> 02:42:03,889
COMPOSITION FUNCTIONALITY AND

3292
02:42:03,889 --> 02:42:05,257
THOSE WILL CHANGE OVER LIFE IN

3293
02:42:05,257 --> 02:42:06,258
RESPONSE TO ILLNESS AND MAY BE

3294
02:42:06,258 --> 02:42:09,762
AS A CAUSE OF ILLNESS.

3295
02:42:09,762 --> 02:42:14,900
FROM INFANTS IN MANY WAYS ARE

3296
02:42:14,900 --> 02:42:15,501
DIFFICULT TO STUDY BECAUSE OF

3297
02:42:15,501 --> 02:42:18,404
LIMITATIONS ON SAFETY OF

3298
02:42:18,404 --> 02:42:22,641
INTERVENTIONS ON THE OTHER HAND

3299
02:42:22,641 --> 02:42:23,676
WITH THE MICRO BIOME THEY ARE

3300
02:42:23,676 --> 02:42:25,811
UNIQUELY SUITABLE FOR

3301
02:42:25,811 --> 02:42:29,882
HIGH-FREQUENCY TO RESIDE IN

3302
02:42:29,882 --> 02:42:40,426
ENVIRONMENTS WHERE THERE'S NOT A

3303
02:42:41,127 --> 02:42:41,660
LOT OF IN AND OUT MAYBE GO OFF

3304
02:42:41,660 --> 02:42:42,261
THE FLOOR FOR THE X-RAY STUDY

3305
02:42:42,261 --> 02:42:42,828
BUT LARGELY IN 1 GEOGRAPHIC

3306
02:42:42,828 --> 02:42:43,362
SPACE AND THE ECOSPHERE IS

3307
02:42:43,362 --> 02:42:43,796
FAIRLY WELL-MANAGED.

3308
02:42:43,796 --> 02:42:44,330
NO PETS RELATIVELY LIMITED

3309
02:42:44,330 --> 02:42:54,874
NUMBER OF HANDLERS AND FEW ORAL

3310
02:42:59,578 --> 02:42:59,812
ANTIBIOTICS.

3311
02:42:59,812 --> 02:43:00,346
IT IS A GOOD OBSERVATIONAL

3312
02:43:00,346 --> 02:43:00,946
ECOLOGICAL STUDY HOW DOES THE

3313
02:43:00,946 --> 02:43:01,547
BACTERIA GET IN THERE WHERE DO

3314
02:43:01,547 --> 02:43:02,148
THEY COME FROM AND EXPAND AND

3315
02:43:02,148 --> 02:43:02,781
HOW MIGHT THEY HAVE THE ABILITY

3316
02:43:02,781 --> 02:43:05,050
TO INFLUENCE OUTCOMES WITHIN THE

3317
02:43:05,050 --> 02:43:05,684
SEVERAL MONTHS THAT THEY LIVE IN

3318
02:43:05,684 --> 02:43:06,552
THE NICU?

3319
02:43:06,552 --> 02:43:10,823
FURTHERMORE 1 OF THE GOOD SIDES

3320
02:43:10,823 --> 02:43:11,423
OF MEDICAL RECORDS CAPTURES A

3321
02:43:11,423 --> 02:43:20,099
LOT OF DATA THAT IS CONCEIVABLY

3322
02:43:20,099 --> 02:43:20,733
MINEABLE AS YOU TRY TO CORRELATE

3323
02:43:20,733 --> 02:43:21,233
ECOLOGICAL CHANGES WITH

3324
02:43:21,233 --> 02:43:21,867
INTERVENTIONS AND ENVIRONMENTAL

3325
02:43:21,867 --> 02:43:24,803
INFLUENCE.

3326
02:43:24,803 --> 02:43:28,040
ABOUT 16 YEARS AGO IN RESPONSE

3327
02:43:28,040 --> 02:43:30,976
TO THE MICRO BIOME PROJECT, WE

3328
02:43:30,976 --> 02:43:37,583
WERE FUNDED TO STUDY PRETERM TO

3329
02:43:37,583 --> 02:43:38,184
FIND MICROBIAL DETERMINANTS OF

3330
02:43:38,184 --> 02:43:48,627
NECROTIZING ENTEROCOLITIS.

3331
02:43:53,199 --> 02:43:53,566
I WOULD LIKE TO GIVE

3332
02:43:53,566 --> 02:43:54,166
ACKNOWLEDGMENT TO NIAID TO GET

3333
02:43:54,166 --> 02:43:54,767
INTO THIS SPACE THERE WERE NO

3334
02:43:54,767 --> 02:43:55,367
INFECTIONS INVOLVED WE STARTED

3335
02:43:55,367 --> 02:43:55,935
OUT SO IT WAS A GAMBLE SO I

3336
02:43:55,935 --> 02:43:56,535
REALLY WANT TO THANK THEM FOR

3337
02:43:56,535 --> 02:44:05,578
FUNDING OUR 2 VALIDATION COHORTS

3338
02:44:05,578 --> 02:44:06,111
BEING ASSEMBLED AT 2 OTHER

3339
02:44:06,111 --> 02:44:06,712
CENTERS SIMULTANEOUSLY GIVING

3340
02:44:06,712 --> 02:44:07,146
MORE CREDENCE TO THE

3341
02:44:07,146 --> 02:44:07,780
OBSERVATIONAL STUDY AT ST. LOUIS

3342
02:44:07,780 --> 02:44:15,454
CHILDREN'S HOSPITAL.

3343
02:44:15,454 --> 02:44:16,088
SO THE FIRST ROUND OF DATA THAT

3344
02:44:16,088 --> 02:44:16,722
WE GENERATED WAS A STUDY NONE OF

3345
02:44:16,722 --> 02:44:17,957
THEM DEVELOPED NECROTIZING

3346
02:44:17,957 --> 02:44:18,290
ENTEROCOLITIS.

3347
02:44:18,290 --> 02:44:24,597
WAS A SMALL COHORT I DON'T THINK

3348
02:44:24,597 --> 02:44:25,164
THERE WAS A SINGLE POSITIVE

3349
02:44:25,164 --> 02:44:26,065
BLOOD CULTURE AND ALL BLOOD

3350
02:44:26,065 --> 02:44:32,137
STOOLS -- -- ALL STOOLS HAD

3351
02:44:32,137 --> 02:44:34,206
SEQUENCING THIS IS ALREADY

3352
02:44:34,206 --> 02:44:38,043
ANCIENT HISTORY THROUGH DAY 30

3353
02:44:38,043 --> 02:44:43,616
AND THEN EVERY 3 DAYS AFTER.

3354
02:44:43,616 --> 02:44:52,358
922 STOOLS AND 7000 ON AVERAGE

3355
02:44:52,358 --> 02:44:53,158
PER STOOL SO THE FIRST ROUND THE

3356
02:44:53,158 --> 02:45:01,467
DATA WE FOUND WERE IMMUNE THE

3357
02:45:01,467 --> 02:45:02,134
CONFRONTED WITH MARKEDLY DIVERSE

3358
02:45:02,134 --> 02:45:02,668
POPULATION YOU CAN SEE THE

3359
02:45:02,668 --> 02:45:03,202
DISTRIBUTION OF DIFFERENT

3360
02:45:03,202 --> 02:45:06,171
CLASSES OF BACTERIA ALMOST ALL

3361
02:45:06,171 --> 02:45:07,072
OF THEM THE MAJORITY OF

3362
02:45:07,072 --> 02:45:10,776
MICROBIAL BACTERIA A RANDOM

3363
02:45:10,776 --> 02:45:13,312
STOOL WITH THE SEQUENCES OVER

3364
02:45:13,312 --> 02:45:16,215
HALF WOULD BE GRAHAM NEGATIVE

3365
02:45:16,215 --> 02:45:24,290
BACILLI.

3366
02:45:24,290 --> 02:45:24,923
IN THERE BUT NOT YET PREDOMINANT

3367
02:45:24,923 --> 02:45:25,557
AS IT WOULD BE THE ADULT STOOL.

3368
02:45:25,557 --> 02:45:27,960
SO WE ARE ALREADY DEALING WITH

3369
02:45:27,960 --> 02:45:32,598
SOME SEVERE OUTCOMES.

3370
02:45:32,598 --> 02:45:33,699
THAT SOUNDS GOOD BUT ON THE

3371
02:45:33,699 --> 02:45:36,969
OTHER HAND LOOK AT THIS ON THE

3372
02:45:36,969 --> 02:45:38,237
INDIVIDUAL LEVEL IT IS 1

3373
02:45:38,237 --> 02:45:42,741
PARTICIPANT AND THE FIRST THING

3374
02:45:42,741 --> 02:45:48,347
YOU SEE IS YOU ARE OBLIGATED TO

3375
02:45:48,347 --> 02:45:48,947
TAKE WHATEVER YOU CAN GET WITH

3376
02:45:48,947 --> 02:45:55,988
THE STOOL YOU CANNOT SCHEDULE SO

3377
02:45:55,988 --> 02:45:56,588
IF YOU CAN MOVE THE NUMBERS IT

3378
02:45:56,588 --> 02:45:57,122
IS QUITE IRREGULAR AND WE

3379
02:45:57,122 --> 02:45:58,557
CALCULATE WE WOULD GET A STOOL

3380
02:45:58,557 --> 02:46:06,165
ON AVERAGE ABOUT ONCE EVERY 2

3381
02:46:06,165 --> 02:46:06,665
AND HALF DAYS SO IS NOT

3382
02:46:06,665 --> 02:46:07,266
CONTINUOUS MONITORING ALTHOUGH

3383
02:46:07,266 --> 02:46:08,200
NOT PERFECT IT IS RISK-FREE

3384
02:46:08,200 --> 02:46:13,339
SPECIMENS AND NOT A BIG DEAL TO

3385
02:46:13,339 --> 02:46:14,239
COLLECT IT AND THEN WE STARTED

3386
02:46:14,239 --> 02:46:17,943
SEQUENCING.

3387
02:46:17,943 --> 02:46:27,786
THIS SINGLE PATIENT DID FAIRLY

3388
02:46:27,786 --> 02:46:28,287
WELL BUT YOU CAN SEE THE

3389
02:46:28,287 --> 02:46:28,787
PROGRESSION OF MICROBES.

3390
02:46:28,787 --> 02:46:29,421
EARLY ON IN THE FIRST WEEK OR 2

3391
02:46:29,421 --> 02:46:32,224
OF LIFE THE BLUE PART OF THOSE

3392
02:46:32,224 --> 02:46:40,065
COLUMNS REPRESENT GRAM-POSITIVE.

3393
02:46:40,065 --> 02:46:41,967
THE RED OR THE PINK IS

3394
02:46:41,967 --> 02:46:44,870
GRAM-NEGATIVE AND YOU CAN SEE

3395
02:46:44,870 --> 02:46:54,580
THERE IS BLUE THERE ARE DAY TO

3396
02:46:54,580 --> 02:46:55,180
DAY INSTABILITIES BUT OVERALL

3397
02:46:55,180 --> 02:46:55,781
YOU CAN SEE THE TREND WHEN YOU

3398
02:46:55,781 --> 02:46:58,016
PUT IT TOGETHER YOU WILL COME UP

3399
02:46:58,016 --> 02:47:01,387
WITH A RECOGNIZABLE PATTERN WITH

3400
02:47:01,387 --> 02:47:05,124
THE BACTERIA THAT WILL BE

3401
02:47:05,124 --> 02:47:08,060
PRESENT AND WILL PREDOMINATE FOR

3402
02:47:08,060 --> 02:47:11,363
A FEW WEEKS AND THEN THEY WILL

3403
02:47:11,363 --> 02:47:13,665
BE REPLACED BY ANAEROBES AND FOR

3404
02:47:13,665 --> 02:47:14,500
THE REST OF THE HEALTHY LIFE

3405
02:47:14,500 --> 02:47:21,907
THAT WILL PREDOMINATE.

3406
02:47:21,907 --> 02:47:22,541
AND THEN DAY TO DAY DISRUPTIONS

3407
02:47:22,541 --> 02:47:23,142
WE DON'T KNOW WHAT CAUSES THEM

3408
02:47:23,142 --> 02:47:26,211
AND WE DON'T KNOW THE

3409
02:47:26,211 --> 02:47:31,750
IMPLICATIONS BUT YOU CAN IMAGINE

3410
02:47:31,750 --> 02:47:32,384
IF YOU DO A SINGLE CASE-CONTROL

3411
02:47:32,384 --> 02:47:36,355
STUDY IT WILL BE A PROBLEM IF

3412
02:47:36,355 --> 02:47:36,855
YOU'RE TRYING TO RELATE

3413
02:47:36,855 --> 02:47:38,590
SOMETHING LIKE THIS TO AN

3414
02:47:38,590 --> 02:47:40,359
OUTCOME YOU CANNOT JUST TAKE 1

3415
02:47:40,359 --> 02:47:45,631
SPECIMEN DASH SPECIMEN TO

3416
02:47:45,631 --> 02:47:49,168
CHARACTERIZE 1 PERSON VERSUS

3417
02:47:49,168 --> 02:47:50,169
ANOTHER AND THE WAY WE HANDLED

3418
02:47:50,169 --> 02:47:55,507
IT TO SMOOTH THAT OVER WITH A

3419
02:47:55,507 --> 02:47:56,108
LOT OF CHILDREN AND SPECIMENS

3420
02:47:56,108 --> 02:47:57,309
THIS IS A SINGLE PATIENT

3421
02:47:57,309 --> 02:48:04,183
STARTING OFF WITH GRAM-POSITIVE

3422
02:48:04,183 --> 02:48:09,521
AND THEN THE NEXT DAY IS

3423
02:48:09,521 --> 02:48:10,055
DOMINATED BY GRAM-NEGATIVE

3424
02:48:10,055 --> 02:48:11,623
BACTERIA AND THEN YOU SEE IT

3425
02:48:11,623 --> 02:48:15,627
INCHING UP DAY BY DAY STOOL

3426
02:48:15,627 --> 02:48:17,996
SEQUENCE NOT THE WHEN I SHOWED

3427
02:48:17,996 --> 02:48:24,203
BEFORE AND THEN WHERE THE

3428
02:48:24,203 --> 02:48:24,837
PATIENT WILL HARBOR A POPULATION

3429
02:48:24,837 --> 02:48:31,977
OF BACTERIA.

3430
02:48:31,977 --> 02:48:32,478
THERE WAS A VERY TELLING

3431
02:48:32,478 --> 02:48:33,078
DIFFERENCE BETWEEN CHILDREN'S

3432
02:48:33,078 --> 02:48:36,582
PROGRESSION OF THE MICROBES

3433
02:48:36,582 --> 02:48:40,018
DEPENDING ON THEIR GESTATIONAL

3434
02:48:40,018 --> 02:48:46,925
AGE AT BIRTH SO RIGHT HERE YOU

3435
02:48:46,925 --> 02:48:47,526
CAN SEE THIS CLUSTER RISING AT

3436
02:48:47,526 --> 02:48:51,330
THIS RATE IT IS SLOWER THAN

3437
02:48:51,330 --> 02:48:51,930
THOSE RISING AT THIS RATE AND

3438
02:48:51,930 --> 02:48:59,471
THE STATISTICIAN WAS IMPRESSED

3439
02:48:59,471 --> 02:49:00,072
WITH THE SIGNIFICANCE OF THIS

3440
02:49:00,072 --> 02:49:00,706
CLEARLY A DIFFERENT POPULATION

3441
02:49:00,706 --> 02:49:01,273
THAN THIS AND THESE CHILDREN

3442
02:49:01,273 --> 02:49:04,109
WERE BORN BETWEEN 25 AND 28

3443
02:49:04,109 --> 02:49:10,582
WEEKS OF GESTATION AND BORN JUST

3444
02:49:10,582 --> 02:49:11,183
SHORT OF GESTATION SO IT IS A

3445
02:49:11,183 --> 02:49:14,419
SLOWER EVOLUTION -- -- EVOLUTION

3446
02:49:14,419 --> 02:49:16,855
TO GET TO THAT MORE ADULT LIKE

3447
02:49:16,855 --> 02:49:22,961
FORMATION WE RAN A LOT OF

3448
02:49:22,961 --> 02:49:27,799
ANALYSIS WITH THE COMMUNITY

3449
02:49:27,799 --> 02:49:28,400
STRUCTURE YOU CAN SEE THAT IT

3450
02:49:28,400 --> 02:49:30,569
DOES SUGGEST THAT THE MOST

3451
02:49:30,569 --> 02:49:33,505
PRETERM HAS A SLOWER

3452
02:49:33,505 --> 02:49:34,039
DEVELOPMENTAL PACE BUT AT

3453
02:49:34,039 --> 02:49:36,708
APPROXIMATELY THE SAME TIME IF

3454
02:49:36,708 --> 02:49:38,844
YOU RELATE THE CHILD'S AGE TO

3455
02:49:38,844 --> 02:49:43,081
POST MENSTRUAL AND THEN IT DOES

3456
02:49:43,081 --> 02:49:45,083
NOT AFFECT ANY MICROBIAL CONTENT

3457
02:49:45,083 --> 02:49:48,854
AND THE DELIVERY DOES NOT HAVE

3458
02:49:48,854 --> 02:49:50,589
MUCH INFLUENCE THERE EITHER.

3459
02:49:50,589 --> 02:50:00,766
HOWEVER IN A FOLLOW-ON STUDY IN

3460
02:50:00,766 --> 02:50:01,400
THE LAB TECHNOLOGY IS ADVANCING

3461
02:50:01,400 --> 02:50:02,034
AS META- GENOMIC SEQUENCING AND

3462
02:50:02,034 --> 02:50:05,504
SHE LOOKED AT THE SAME COHORT

3463
02:50:05,504 --> 02:50:06,572
MANY OF THE SAME STOOLS TO FIND

3464
02:50:06,572 --> 02:50:07,739
WHEN YOU BREAK IT OUT WITH

3465
02:50:07,739 --> 02:50:13,645
DIFFERENT ANTIBIOTICS TO REDUCE

3466
02:50:13,645 --> 02:50:14,913
DIVERSITY OF THE MICROBIAL

3467
02:50:14,913 --> 02:50:18,984
CONTENT ALL IN AGGREGATE SOME

3468
02:50:18,984 --> 02:50:22,287
ACTUALLY INCREASED DIVERSITY

3469
02:50:22,287 --> 02:50:28,293
LIKE ERYTHROMYCIN AND ALSO SHE

3470
02:50:28,293 --> 02:50:34,800
DID FUNCTIONAL SCREENING LOOKING

3471
02:50:34,800 --> 02:50:35,334
FOR ANTIBIOTIC RESISTANCE

3472
02:50:35,334 --> 02:50:36,301
CONFIRMED ELEMENTS AND FOUND A

3473
02:50:36,301 --> 02:50:42,975
REASONABLE NUMBER AND THIS IS ON

3474
02:50:42,975 --> 02:50:43,609
THE PEAK AND THEY WERE NOT FOUND

3475
02:50:43,609 --> 02:50:47,312
IN THE DATABASE OF ANTIMICROBIAL

3476
02:50:47,312 --> 02:50:47,613
RESISTANCE.

3477
02:50:47,613 --> 02:50:58,090
THE PROBLEM STILL PERSISTS.

3478
02:50:58,457 --> 02:50:59,024
SO WE ARE PROBABLY MISSING MORE

3479
02:50:59,024 --> 02:51:06,565
THAN WE NO. SO WE EXTENDED THE

3480
02:51:06,565 --> 02:51:09,267
INITIAL ROUND OF COMPARISONS TO

3481
02:51:09,267 --> 02:51:15,273
CHILDREN WHO HAVE NECROTIZING

3482
02:51:15,273 --> 02:51:16,241
ENTEROCOLITIS ALL STOOLS ALL THE

3483
02:51:16,241 --> 02:51:20,445
TIME GO BACK TO THE FREEZER AS A

3484
02:51:20,445 --> 02:51:22,881
WHAT DID WE HAD PRIOR TO THE

3485
02:51:22,881 --> 02:51:25,450
EVENT?

3486
02:51:25,450 --> 02:51:26,051
166 PATIENTS WERE IN THE STUDY

3487
02:51:26,051 --> 02:51:30,555
AND MATCH THEM TO CONTROLS WITH

3488
02:51:30,555 --> 02:51:31,189
THE GESTATIONAL AGE OF BIRTH AND

3489
02:51:31,189 --> 02:51:35,227
BIRTH WEIGHT.

3490
02:51:35,227 --> 02:51:37,796
3500 DIFFERENT STOOLS WERE

3491
02:51:37,796 --> 02:51:40,932
SEQUENCED 6000 MEANS PER 12 THIS

3492
02:51:40,932 --> 02:51:45,337
IS 2012 IN TERMS OF TECHNOLOGY

3493
02:51:45,337 --> 02:51:48,707
BUT NOW WE CAN HAVE A REASONABLE

3494
02:51:48,707 --> 02:51:51,143
DATABASE TO SAY WHAT IS

3495
02:51:51,143 --> 02:51:51,610
DIFFERENT PRIOR TO THE

3496
02:51:51,610 --> 02:51:55,881
DEVELOPMENT OF NEC COMPARED TO

3497
02:51:55,881 --> 02:51:56,815
CONTROLS THAT DO NOT.

3498
02:51:56,815 --> 02:52:02,554
SO BASICALLY THEY DEVELOP NEC

3499
02:52:02,554 --> 02:52:07,125
AFTER 30 DAYS OF AGE HAVE A FREE

3500
02:52:07,125 --> 02:52:10,662
EVENT SURGE OF GRAM-NEGATIVE

3501
02:52:10,662 --> 02:52:12,397
BACTERIA THOSE THAT ARE

3502
02:52:12,397 --> 02:52:17,469
PROTECTED SEEM TO START ON THE

3503
02:52:17,469 --> 02:52:21,907
PATH TO HOLDING ONTO NURSE

3504
02:52:21,907 --> 02:52:23,942
SHARING AND HANGING ONTO

3505
02:52:23,942 --> 02:52:34,119
ANAEROBES.

3506
02:52:42,627 --> 02:52:43,161
THESE ARE THE GRAM-NEGATIVE'S

3507
02:52:43,161 --> 02:52:43,762
BUT WE DON'T SEE THAT FOR THE

3508
02:52:43,762 --> 02:52:44,329
KIDS THAT DEVELOP NEC ON OR

3509
02:52:44,329 --> 02:52:44,663
BEFORE DAY 30.

3510
02:52:44,663 --> 02:52:48,400
AGAIN WE SUBJECTED THIS TO A

3511
02:52:48,400 --> 02:52:49,067
VARIABLES STUDY THE STATISTICIAN

3512
02:52:49,067 --> 02:52:51,403
TELLS US THAT FOR ALL

3513
02:52:51,403 --> 02:52:55,841
GESTATIONAL AGES DRIVEN FOR

3514
02:52:55,841 --> 02:52:59,478
CHILDREN BORN TO THE 427 WEEKS

3515
02:52:59,478 --> 02:53:00,378
GESTATION WE HAVE SIGNIFICANTLY

3516
02:53:00,378 --> 02:53:02,247
MORE BACTERIA THAT ARE

3517
02:53:02,247 --> 02:53:06,251
DEVELOPING NEC AND SIGNIFICANTLY

3518
02:53:06,251 --> 02:53:10,889
WE WERE NEGATIVE ACTIVITIES.

3519
02:53:10,889 --> 02:53:16,995
CHILDREN BORN AFTER 27 WEEKS DID

3520
02:53:16,995 --> 02:53:17,395
NOT SEE A SIGNAL.

3521
02:53:17,395 --> 02:53:19,397
THEN LOOK AT THE VALIDATION

3522
02:53:19,397 --> 02:53:20,465
COHORTS WE HAVE THE SAME

3523
02:53:20,465 --> 02:53:26,138
ASSOCIATION WITH ST. LOUIS WHERE

3524
02:53:26,138 --> 02:53:29,107
THE RISK OF DEVELOPING NEC THAT

3525
02:53:29,107 --> 02:53:34,279
CHIEFLY THOSE WITH THOSE LESS

3526
02:53:34,279 --> 02:53:34,846
THAN 27 WEEKS NOT THOSE BORN

3527
02:53:34,846 --> 02:53:45,123
AFTER 27 WEEKS.

3528
02:53:46,358 --> 02:53:46,892
THIS LINES UP WITH NECROTIZING

3529
02:53:46,892 --> 02:53:47,492
ENTEROCOLITIS THE SHORTER THE

3530
02:53:47,492 --> 02:53:48,126
GESTATION THE CHILD HAS A LATER

3531
02:53:48,126 --> 02:53:48,994
THEY DEVELOP NEC IF THEY DO.

3532
02:53:48,994 --> 02:53:57,269
WITH THE DIFFERENT BACTERIA WITH

3533
02:53:57,269 --> 02:53:58,136
GAMMA PROTEIN BACTERIA E. COLI

3534
02:53:58,136 --> 02:54:01,540
THEN SUBSETS WITH SPECIFIC

3535
02:54:01,540 --> 02:54:12,083
STRAINS IT IS ALWAYS POPPING UP

3536
02:54:18,089 --> 02:54:18,657
BUT IF YOU LOOK AT THE DIFFERENT

3537
02:54:18,657 --> 02:54:19,224
PIE CHARTS THERE IS A LOT OF

3538
02:54:19,224 --> 02:54:19,791
VARIABILITY THESE PIE CHARTS

3539
02:54:19,791 --> 02:54:20,358
REPRESENT THE GRAM-NEGATIVE

3540
02:54:20,358 --> 02:54:20,859
OVERREPRESENTED WITH THE

3541
02:54:20,859 --> 02:54:21,493
AGGREGATE BUT NOTHING IS JUMPING

3542
02:54:21,493 --> 02:54:22,127
OUT IN SOME CENTERS E. COLI IS

3543
02:54:22,127 --> 02:54:22,727
PREDOMINANT BUT ON THE OTHER

3544
02:54:22,727 --> 02:54:24,763
HAND AMONG THE CHILDREN CONTROLS

3545
02:54:24,763 --> 02:54:29,067
THE NEGATIVE PROCLIVITIES IT

3546
02:54:29,067 --> 02:54:34,639
SEEMED TO BE THE SAME SO WE TALK

3547
02:54:34,639 --> 02:54:45,150
ABOUT CAUSALITY IN 1 CENTER BUT

3548
02:54:45,150 --> 02:54:45,784
IT MAY JUST REFLECT THAT CENTER

3549
02:54:45,784 --> 02:54:46,384
BUT THE COMMON DENOMINATOR OF

3550
02:54:46,384 --> 02:54:47,018
THE OFFENSIVE POPULATION MAY NOT

3551
02:54:47,018 --> 02:54:47,652
BE AT THE GENUS OR SPECIES LEVEL

3552
02:54:47,652 --> 02:54:50,188
BUT A SHARED TRAIT LEVEL.

3553
02:54:50,188 --> 02:54:56,628
AS WE HEARD A LITTLE BEFORE

3554
02:54:56,628 --> 02:54:57,162
ABOUT POLYSACCHARIDE TO BE

3555
02:54:57,162 --> 02:54:59,197
UPREGULATED IN INFANTS AFTER

3556
02:54:59,197 --> 02:55:00,232
BIRTH SO AT LEAST IT IS A

3557
02:55:00,232 --> 02:55:02,567
WORKING HYPOTHESIS.

3558
02:55:02,567 --> 02:55:07,739
BUT I'D LIKE TO GET BACK TO

3559
02:55:07,739 --> 02:55:07,939
THIS.

3560
02:55:07,939 --> 02:55:08,473
YES IT IS TRUE YOU ARE AT

3561
02:55:08,473 --> 02:55:09,207
GREATER RISK BUT IT IS NOT

3562
02:55:09,207 --> 02:55:11,710
CATEGORICAL IT IS TWOFOLD OR

3563
02:55:11,710 --> 02:55:17,515
THREEFOLD AND IT IS HARD TO SAY

3564
02:55:17,515 --> 02:55:18,149
YOU CAN JUST DOUBLE OR TRIPLE A

3565
02:55:18,149 --> 02:55:18,750
PROPORTION OF AN ORGANISM YOU

3566
02:55:18,750 --> 02:55:29,294
HAVE A CATASTROPHIC OUTCOME THAT

3567
02:55:33,098 --> 02:55:33,632
WILL KILL THE DIGESTIVE SYSTEM

3568
02:55:33,632 --> 02:55:34,099
SO WHILE THERE IS THE

3569
02:55:34,099 --> 02:55:34,699
ASSOCIATION I AM NOT SURE THE

3570
02:55:34,699 --> 02:55:35,233
SINGLE ORGANISM INJURY THE

3571
02:55:35,233 --> 02:55:35,834
PARADIGM THAT WE HAVE LEARNED

3572
02:55:35,834 --> 02:55:36,434
WITH INFECTIOUS DISEASES WILL

3573
02:55:36,434 --> 02:55:37,235
HOLD WE HAVE THESE POPULATIONS

3574
02:55:37,235 --> 02:55:39,504
THAT TILT BUT ARE FAR FROM

3575
02:55:39,504 --> 02:55:48,313
CATEGORICAL.

3576
02:55:48,313 --> 02:55:48,914
THEN WITH A DEEPER DIVE THE

3577
02:55:48,914 --> 02:55:49,514
STUDY KEEPS GOING SAME COHORT

3578
02:55:49,514 --> 02:55:50,982
AND SPECIMENS AND FREEZERS AND

3579
02:55:50,982 --> 02:56:01,526
DATABASE AND A POSTDOC RECENTLY

3580
02:56:05,130 --> 02:56:05,697
PUBLISHED A STUDY AGAIN WITH THE

3581
02:56:05,697 --> 02:56:06,264
SAME COHORT 236 INFANTS THIS

3582
02:56:06,264 --> 02:56:06,831
TIME STARTING OUT WANTING TO

3583
02:56:06,831 --> 02:56:07,399
DEFINE IN GREATER DETAIL THE

3584
02:56:07,399 --> 02:56:07,999
PROFESSIONAL MICROBES AND THEN

3585
02:56:07,999 --> 02:56:10,869
OF COURSE BLOOD.

3586
02:56:10,869 --> 02:56:18,510
2500 STOOLS 500 PER SAMPLE YOU

3587
02:56:18,510 --> 02:56:19,110
CAN SEE TECHNOLOGY IS MARCHING

3588
02:56:19,110 --> 02:56:19,678
FORWARD AND SOME INTERESTING

3589
02:56:19,678 --> 02:56:25,016
SETS OF DATA CAME OUT.

3590
02:56:25,016 --> 02:56:26,618
BACTERIA IN THE AGGREGATE OR

3591
02:56:26,618 --> 02:56:34,492
ASSOCIATED THAT SEEMS TO BE

3592
02:56:34,492 --> 02:56:35,026
PROTECTIVE THEY FOUND THE

3593
02:56:35,026 --> 02:56:35,627
COUPLING DAY OF LIFE 40 NOT 30

3594
02:56:35,627 --> 02:56:41,399
BUT IT IS SIMILAR TO WHAT WE ARE

3595
02:56:41,399 --> 02:56:42,267
INFERRING FROM THE FIRST STUDY

3596
02:56:42,267 --> 02:56:46,271
AND THE APPEAL DB LOGIC DATA.

3597
02:56:46,271 --> 02:56:47,939
BUT ALSO WE FOUND THE FIRST TIME

3598
02:56:47,939 --> 02:56:52,711
WE REALLY LOOKED AT PRESSERS AND

3599
02:56:52,711 --> 02:56:55,747
A FEW OTHER NON- ANTIBIOTIC

3600
02:56:55,747 --> 02:57:02,053
DRUGS.

3601
02:57:02,053 --> 02:57:02,687
BUT IN THIS STUDY ROBERT PULLED

3602
02:57:02,687 --> 02:57:08,159
OUT ALL OF THE MEDICATIONS GIVEN

3603
02:57:08,159 --> 02:57:08,793
TO THE CHILDREN WITH CONTROL SO

3604
02:57:08,793 --> 02:57:10,595
NOT SURPRISINGLY ANTIBIOTICS

3605
02:57:10,595 --> 02:57:19,804
TENDED TO REDUCE THE DENSITY AND

3606
02:57:19,804 --> 02:57:25,710
THE PAPER HAS THE COLOR CODE

3607
02:57:25,710 --> 02:57:26,277
SOMETIMES THEY INCREASE THE

3608
02:57:26,277 --> 02:57:28,380
DENSITY BUT THESE DRUGS ARE NOT

3609
02:57:28,380 --> 02:57:35,153
ANTIBIOTICS.

3610
02:57:35,153 --> 02:57:35,820
VITAMIN D IS ON THEIR IRON IS ON

3611
02:57:35,820 --> 02:57:36,021
THERE.

3612
02:57:36,021 --> 02:57:36,621
THAT COULD ALTER A POPULATION

3613
02:57:36,621 --> 02:57:47,098
AND REALLY WE DO NOT LOOK AT

3614
02:57:52,537 --> 02:57:52,971
NON- ANTIBIOTIC DRUGS AS

3615
02:57:52,971 --> 02:57:53,571
INFLUENCING MICROBIAL CONTENT

3616
02:57:53,571 --> 02:57:54,039
BUT PROBABLY I SHOULD.

3617
02:57:54,039 --> 02:57:54,606
THERE IS SOME DATA FROM OLD

3618
02:57:54,606 --> 02:57:55,240
LITERATURE NOT JUST ANTIBIOTICS

3619
02:57:55,240 --> 02:57:55,774
THAT AFFECT THE MICROBES.

3620
02:57:55,774 --> 02:57:56,374
A COUPLE OTHER SPINOFF SETS OF

3621
02:57:56,374 --> 02:57:57,742
DATA.

3622
02:57:57,742 --> 02:57:58,309
WHAT I SHOWED YOU WITH THE

3623
02:57:58,309 --> 02:57:58,943
ABRUPTNESS THAT IS A RISK FACTOR

3624
02:57:58,943 --> 02:58:07,919
WERE A CHILD HAS WHERE NICK --

3625
02:58:07,919 --> 02:58:08,553
-- NEC WAS CUT LIKELY TO FOLLOW

3626
02:58:08,553 --> 02:58:09,087
AND THE SHIFTS SEEM TO BE

3627
02:58:09,087 --> 02:58:09,721
PRECIPITATED BY ANTIBIOTICS NOT

3628
02:58:09,721 --> 02:58:13,725
THAT SURPRISING THE EPISODE OF

3629
02:58:13,725 --> 02:58:17,062
NEC OCCURS 15 DAYS LATER AND

3630
02:58:17,062 --> 02:58:21,166
WHEN BUGS ARE REPOPULATED AFTER

3631
02:58:21,166 --> 02:58:21,666
SHIFT THERE IS MUCH MORE

3632
02:58:21,666 --> 02:58:23,368
RESISTANCE TO GENES IN THEM.

3633
02:58:23,368 --> 02:58:33,711
IS NOT JUST REPLACING IT NOT

3634
02:58:33,711 --> 02:58:34,312
JUST KNOCKING DOWN E. COLI AND

3635
02:58:34,312 --> 02:58:34,946
COMING BACK NOW YOU ARE REPLACED

3636
02:58:34,946 --> 02:58:35,547
BY MORE RESISTANT BUGS WHETHER

3637
02:58:35,547 --> 02:58:36,181
OR NOT THEY ARE PATHOGENS THAT

3638
02:58:36,181 --> 02:58:36,915
DEPENDS ON YOUR DEFINITION

3639
02:58:36,915 --> 02:58:39,451
HAVING BACTERIAL TRANSCRIPTION

3640
02:58:39,451 --> 02:58:41,586
COMPONENT IT DID ADD A LITTLE

3641
02:58:41,586 --> 02:58:47,625
MORE SENSITIVITY TO THE GENOMIC

3642
02:58:47,625 --> 02:58:48,259
COMPONENT IN THAT STUDY IN TERMS

3643
02:58:48,259 --> 02:58:54,099
OF RISK BUT IT WAS NOT MAJOR DNA

3644
02:58:54,099 --> 02:58:54,732
MUCH LESS EXPENSIVE TO SEQUENCE

3645
02:58:54,732 --> 02:58:55,200
THE AND RNA IS A GOOD

3646
02:58:55,200 --> 02:58:58,503
APPROXIMATION OF A POPULATION.

3647
02:58:58,503 --> 02:59:01,072
THIS WAS FASCINATING WITHIN

3648
02:59:01,072 --> 02:59:08,213
CENTERS WHAT WAS ISOLATED IT WAS

3649
02:59:08,213 --> 02:59:08,813
ISOGENIC YEAR AFTER YEAR AFTER

3650
02:59:08,813 --> 02:59:13,017
YEAR.

3651
02:59:13,017 --> 02:59:13,551
AND IN ST. LOUIS AND IN

3652
02:59:13,551 --> 02:59:14,219
LOUISVILLE AND OKLAHOMA HAVE

3653
02:59:14,219 --> 02:59:22,527
THEIR OWN UNIQUE.

3654
02:59:22,527 --> 02:59:25,997
STAFF WAS IDENTICAL BETWEEN

3655
02:59:25,997 --> 02:59:28,700
CENTERS ALMOST NO NUCLEOTIDE

3656
02:59:28,700 --> 02:59:33,004
DIFFERENCE BETWEEN THE STAFF AND

3657
02:59:33,004 --> 02:59:33,905
THE STOOL IN ST. LOUIS OR IN

3658
02:59:33,905 --> 02:59:44,082
OKLAHOMA.

3659
02:59:46,551 --> 02:59:47,118
NOW SENSE EVERYTHING IS NEW I DO

3660
02:59:47,118 --> 02:59:47,752
WANT TO SHOW 1 LITTLE HISTORICAL

3661
02:59:47,752 --> 02:59:48,319
FINDING THERE WAS A GROUP IN

3662
02:59:48,319 --> 02:59:48,853
ST. LOUIS SOME OF YOU MAY

3663
02:59:48,853 --> 02:59:55,560
RECOGNIZE THESE NAMES LIKE THE

3664
02:59:55,560 --> 02:59:56,161
PEDIATRIC INFECTIOUS DISEASES

3665
02:59:56,161 --> 02:59:56,761
DOCTOR INTO PEDIATRIC SURGEONS

3666
02:59:56,761 --> 02:59:58,096
CULTURED STOOL IN THE LATE

3667
02:59:58,096 --> 03:00:03,001
SEVENTIES FROM CHILDREN WITH NEC

3668
03:00:03,001 --> 03:00:03,434
AND I AM CERTAIN AND

3669
03:00:03,434 --> 03:00:04,002
EPIDEMIOLOGIST WOULD HAVE A

3670
03:00:04,002 --> 03:00:08,273
HEART ATTACK WHEN THEY SAW THIS

3671
03:00:08,273 --> 03:00:09,741
IS NOW A HIGH FREQUENCY OF

3672
03:00:09,741 --> 03:00:13,144
OCCURRENCE IN THE NICU AND THEN

3673
03:00:13,144 --> 03:00:18,917
NO CASES AND THEN TO STUDY THIS

3674
03:00:18,917 --> 03:00:19,517
1 AND THE DETAILS ARE GETTING

3675
03:00:19,517 --> 03:00:20,919
VAGUE BUT I THINK THEY WERE JUST

3676
03:00:20,919 --> 03:00:25,790
SWAPPING THE COLONIES.

3677
03:00:25,790 --> 03:00:30,461
IN PERIOD A GASTRIC JUICE AND A

3678
03:00:30,461 --> 03:00:37,769
LOT OF E. COLI.

3679
03:00:37,769 --> 03:00:43,708
B NONE IN THE STOMACH SOME IN

3680
03:00:43,708 --> 03:00:44,742
THE STOOL AND THEN BACK HERE

3681
03:00:44,742 --> 03:00:50,348
AGAIN THEY FIND SOMETHING.

3682
03:00:50,348 --> 03:00:50,949
IT IS HARD TO KNOW BUT WE WERE

3683
03:00:50,949 --> 03:00:51,583
NOT THE FIRST GROUP IN ST. LOUIS

3684
03:00:51,583 --> 03:00:55,753
TO ASSOCIATE GAMMA UP RODEO

3685
03:00:55,753 --> 03:00:56,654
BACTERIA WITH NECROTIZING

3686
03:00:56,654 --> 03:01:01,859
ENTEROCOLITIS.

3687
03:01:01,859 --> 03:01:02,393
I WANT TO RUN THROUGH THE

3688
03:01:02,393 --> 03:01:05,563
BLOODSTREAM INFECTIONS.

3689
03:01:05,563 --> 03:01:16,074
CHILDREN WHO HAVE A VERY HIGH

3690
03:01:22,714 --> 03:01:23,147
FREQUENCY OF BLOODSTREAM

3691
03:01:23,147 --> 03:01:23,715
INFECTIONS AND WHILE WE ARE

3692
03:01:23,715 --> 03:01:24,349
GATHERING ENOUGH STOOLS FOR THE

3693
03:01:24,349 --> 03:01:24,949
NEXT STUDY WE SAID LET'S DO A

3694
03:01:24,949 --> 03:01:25,450
PRELIMINARY BLOODSTREAM

3695
03:01:25,450 --> 03:01:26,084
INFECTION STUDY THIS WAS RUN BY

3696
03:01:26,084 --> 03:01:26,751
A MEDICAL STUDENT WHO MAJORED IN

3697
03:01:26,751 --> 03:01:27,418
BACTERIOLOGY IN COLLEGE AND JUST

3698
03:01:27,418 --> 03:01:37,895
TOOK TO THE PROJECT AVIDLY.

3699
03:01:41,399 --> 03:01:41,966
WE KNOW THIS CHILD HAS STREP IN

3700
03:01:41,966 --> 03:01:42,500
THEIR BLOOD LATE ON STREAM

3701
03:01:42,500 --> 03:01:43,134
INFECTIONS WHAT WE HAVE IN THE

3702
03:01:43,134 --> 03:01:43,368
FREEZER?

3703
03:01:43,368 --> 03:01:44,002
TWENTY STOOLS AND HE WOULD FIND

3704
03:01:44,002 --> 03:01:44,636
A DAY OR 2 BEFORE THE CHILD HAD

3705
03:01:44,636 --> 03:01:45,236
THE CLINICAL COLLAPSE TO CAUSE

3706
03:01:45,236 --> 03:01:47,605
THE BLOOD CULTURE GROUP B STREP

3707
03:01:47,605 --> 03:01:51,075
AS THE INFECTION THE CHILD DID

3708
03:01:51,075 --> 03:02:01,619
NOT LOOK SICK WITH NO LINES THEN

3709
03:02:02,987 --> 03:02:03,288
A SIMILAR STORY.

3710
03:02:03,288 --> 03:02:03,921
E. COLI THE CHILDREN HAD SEVERE

3711
03:02:03,921 --> 03:02:04,522
DETERIORATION 2 OR 3 WEEKS OF

3712
03:02:04,522 --> 03:02:05,123
AGE EVERY 1 OF THEIR STOOLS IN

3713
03:02:05,123 --> 03:02:05,690
THE FREEZER WAS FULL OF THE

3714
03:02:05,690 --> 03:02:06,691
EXACT SAME E. COLI AND WE HAVE

3715
03:02:06,691 --> 03:02:11,396
STOOL FROM 1 OF THEIR MOTHERS

3716
03:02:11,396 --> 03:02:11,996
AND THAT WAS ALSO FULL OF THE

3717
03:02:11,996 --> 03:02:16,401
EXACT SAME E. COLI.

3718
03:02:16,401 --> 03:02:17,502
SO NOW THIS IS A PARADIGM OF

3719
03:02:17,502 --> 03:02:24,008
BLOODSTREAM INFECTION IT MAY NOT

3720
03:02:24,008 --> 03:02:24,642
BE COMING FROM THE LINES ARE THE

3721
03:02:24,642 --> 03:02:25,209
VENTILATORS BUT IT COULD BE

3722
03:02:25,209 --> 03:02:25,743
COMING FROM THE GUT.

3723
03:02:25,743 --> 03:02:30,581
SO VERY BRIEFLY DURING HIS

3724
03:02:30,581 --> 03:02:37,889
FELLOWSHIP IN THE LAB SAID I

3725
03:02:37,889 --> 03:02:38,489
WILL DO THIS BETTER SO ON THE

3726
03:02:38,489 --> 03:02:42,060
LEFT IS WHAT MIKE DID CLASSIC

3727
03:02:42,060 --> 03:02:42,694
TIGER BIOLOGY YOU END UP WITH AN

3728
03:02:42,694 --> 03:02:43,661
ORGANISM AT THE END THAT IS VERY

3729
03:02:43,661 --> 03:02:54,105
SATISFYING AND SAID I WILL

3730
03:02:55,707 --> 03:02:56,274
SEQUENCE THIS AND FIND IT MYSELF

3731
03:02:56,274 --> 03:02:56,908
THROUGH STOOL CULTURE AND HE DID

3732
03:02:56,908 --> 03:02:57,442
EXTENDED IT TO 19 CASES OF

3733
03:02:57,442 --> 03:02:58,276
BLOODSTREAM INFECTION, 499

3734
03:02:58,276 --> 03:03:00,945
STOOLS AND WHEN HE HAD THE

3735
03:03:00,945 --> 03:03:01,679
BLOODSTREAM ISOLATE AND THE

3736
03:03:01,679 --> 03:03:04,382
SIGNAL EVIDENCE, EACH OF THE

3737
03:03:04,382 --> 03:03:09,253
ISOLATES WERE SEQUENCED AND

3738
03:03:09,253 --> 03:03:12,757
ISOGENIC SO HE CERTAINLY

3739
03:03:12,757 --> 03:03:14,659
CONFIRMED THE FINDINGS WITH VERY

3740
03:03:14,659 --> 03:03:17,929
GOOD TECHNOLOGY WITH 19

3741
03:03:17,929 --> 03:03:28,039
BLOODSTREAM INFECTION PATIENTS

3742
03:03:28,039 --> 03:03:28,639
COLONIZED IN THE STOOL THAT IS

3743
03:03:28,639 --> 03:03:29,173
THE ULTIMATE BIOMARKER THE

3744
03:03:29,173 --> 03:03:29,707
PATHOGEN GETS IN AND HANGS

3745
03:03:29,707 --> 03:03:30,341
AROUND AND THE PERSON GETS SICK

3746
03:03:30,341 --> 03:03:31,476
AND TOLD A CRASH INTERESTINGLY

3747
03:03:31,476 --> 03:03:34,078
11 OF THOSE 19 PATIENTS HAD 4

3748
03:03:34,078 --> 03:03:35,179
MORE THAT CARRIED THE

3749
03:03:35,179 --> 03:03:39,984
BLOODSTREAM AGENT POST ILLNESS

3750
03:03:39,984 --> 03:03:40,585
THEY WERE TREATED AND DID WELL

3751
03:03:40,585 --> 03:03:41,185
AND STILL HAVE THE PATHOGEN IN

3752
03:03:41,185 --> 03:03:46,624
THEIR STOOL.

3753
03:03:46,624 --> 03:03:47,225
THERE WERE A REASONABLE NUMBER

3754
03:03:47,225 --> 03:03:49,227
OF CONTROLS READ THE SAME

3755
03:03:49,227 --> 03:03:57,468
ORGANISM INCLUDING CHILDREN WHO

3756
03:03:57,468 --> 03:03:58,102
WERE BORN AND LIVED IN THE NICU

3757
03:03:58,102 --> 03:03:58,736
1 OR 2 YEARS EARLIER AND DID NOT

3758
03:03:58,736 --> 03:03:59,270
OVERLAP MAY BE INDIGENOUS

3759
03:03:59,270 --> 03:04:02,306
BACTERIA IN THESE UNITS AND

3760
03:04:02,306 --> 03:04:07,178
FINALLY NOTICING STATISTICALLY

3761
03:04:07,178 --> 03:04:07,712
INFECTIONS WERE INVERSELY

3762
03:04:07,712 --> 03:04:12,650
ASSOCIATED IN THE STOOL.

3763
03:04:12,650 --> 03:04:17,455
THEY JUST NOTED THIS CURIOUSLY

3764
03:04:17,455 --> 03:04:20,024
IN MARTY'S PAPER HE HAD A

3765
03:04:20,024 --> 03:04:24,262
QUOTATION THAT I COULD NOT GET

3766
03:04:24,262 --> 03:04:24,862
YESTERDAY OR I WOULD HAVE WENT

3767
03:04:24,862 --> 03:04:25,296
BACK TO THE SOURCE.

3768
03:04:25,296 --> 03:04:31,502
HE QUOTED A GROUP FOR THE PAS

3769
03:04:31,502 --> 03:04:38,709
SOCIETY 1977 WHERE A GROUP

3770
03:04:38,709 --> 03:04:39,277
CALLED STANLEY'S GROUP SAID

3771
03:04:39,277 --> 03:04:39,844
COLONIZATION IN THE STOOL IS

3772
03:04:39,844 --> 03:04:42,513
ASSOCIATED WITH INCREASED RISK

3773
03:04:42,513 --> 03:04:44,215
OF NECROTIZING ENTEROCOLITIS

3774
03:04:44,215 --> 03:04:46,851
WHILE COLONIZATION WAS

3775
03:04:46,851 --> 03:04:48,619
ASSOCIATED WITH DECREASED

3776
03:04:48,619 --> 03:04:51,522
INCIDENCE.

3777
03:04:51,522 --> 03:04:54,025
AND THERE IS SOME DATA FROM

3778
03:04:54,025 --> 03:04:59,964
HARVARD TO HAVE 2 UNRELATED

3779
03:04:59,964 --> 03:05:01,332
SPECIES INFLUENCING EACH OTHER

3780
03:05:01,332 --> 03:05:06,337
IN A MICROBIAL POPULATION.

3781
03:05:06,337 --> 03:05:06,871
I HAVE TIME TO TALK ABOUT

3782
03:05:06,871 --> 03:05:12,510
STRUCTURE OR FUNCTION CLAIMS OF

3783
03:05:12,510 --> 03:05:15,813
PROBIOTIC THE GASTROENTEROLOGY

3784
03:05:15,813 --> 03:05:22,453
FIELD WE LIKE TO COMMENT NOW WE

3785
03:05:22,453 --> 03:05:23,087
HAVE A NEW ORGAN IN OUR BODY WE

3786
03:05:23,087 --> 03:05:23,721
NEVER HAD UNTIL THE MICRO BIOME

3787
03:05:23,721 --> 03:05:26,824
DATA CAME OUT AND IT MAY BE IN

3788
03:05:26,824 --> 03:05:31,362
YEARS TO COME FOR THE BIOME

3789
03:05:31,362 --> 03:05:35,833
RESPONSES WILL BE A FUNCTION

3790
03:05:35,833 --> 03:05:36,801
THAT YOU CAN MEASURE BIOTICS

3791
03:05:36,801 --> 03:05:38,202
AGAINST.

3792
03:05:38,202 --> 03:05:38,469
THANK YOU.

3793
03:05:38,469 --> 03:05:47,845
[APPLAUSE]

3794
03:05:47,845 --> 03:05:56,554
>> SO THE NEXT SPEAKER
WILL TALK

3795
03:05:56,554 --> 03:05:57,188
TO US ABOUT THE CURRENT STATE OF

3796
03:05:57,188 --> 03:05:58,155
EVIDENCE BUT THE USE OF PRODUCT

3797
03:05:58,155 --> 03:06:01,659
MARKETED AS PROBIOTICS.

3798
03:06:01,659 --> 03:06:02,260
>> I'M HERE TO TALK ABOUT
THE

3799
03:06:02,260 --> 03:06:06,931
ELEPHANT IN THE ROOM.

3800
03:06:06,931 --> 03:06:08,633
MILLER FROM WASHINGTON

3801
03:06:08,633 --> 03:06:13,004
UNIVERSITY TALKING ABOUT THE

3802
03:06:13,004 --> 03:06:13,604
CURRENT STATE OF EVIDENCE FOR

3803
03:06:13,604 --> 03:06:16,941
PROBIOTICS AND A CLINICAL

3804
03:06:16,941 --> 03:06:18,743
IMMUNOLOGIST I LOVE ALL THINGS

3805
03:06:18,743 --> 03:06:28,953
MICRO BIOME.

3806
03:06:35,393 --> 03:06:35,927
NO DISCLOSURES OR CONFLICTS OF

3807
03:06:35,927 --> 03:06:36,494
INTEREST AND BRIEFLY MY GOAL

3808
03:06:36,494 --> 03:06:36,994
TODAY IS TO DO A SHORT

3809
03:06:36,994 --> 03:06:44,268
EXAMINATION OF THE PROBIOTICS

3810
03:06:44,268 --> 03:06:44,902
WITH THE MICRO BIOME THAT IN AND

3811
03:06:44,902 --> 03:06:45,436
OF ITSELF COULD BE A WHOLE

3812
03:06:45,436 --> 03:06:46,070
SERIES OF TALKS I WILL FOCUS ON

3813
03:06:46,070 --> 03:06:50,508
THE ISSUE DO THEY REALLY GET IN

3814
03:06:50,508 --> 03:06:51,142
THERE AND STAY AND THEN WHAT IS

3815
03:06:51,142 --> 03:06:58,649
THE INTERACTION IN THE CONTEXT

3816
03:06:58,649 --> 03:06:59,283
OF THIS IDEA OF TRAJECTORY THAT

3817
03:06:59,283 --> 03:06:59,850
WE JUST HEARD TO TALK ABOUT?

3818
03:06:59,850 --> 03:07:00,484
AND TO HIGHLIGHT THE IMPORTANCE

3819
03:07:00,484 --> 03:07:03,988
OF SPECIES THAT ARE USED TO

3820
03:07:03,988 --> 03:07:05,456
SUMMARIZE THE CLINICAL STUDIES

3821
03:07:05,456 --> 03:07:07,491
OF PROBIOTICS AND MAY BE A SHORT

3822
03:07:07,491 --> 03:07:14,298
LOOK AT THE FUTURE.

3823
03:07:14,298 --> 03:07:14,932
>> HERE JUST TO PRESENT
THE DATA

3824
03:07:14,932 --> 03:07:16,901
I WILL BE FOCUSING ON THE HUMAN

3825
03:07:16,901 --> 03:07:21,138
DATA SO THE FIRST IDEA OF

3826
03:07:21,138 --> 03:07:31,649
ENGRAFTMENT ARE THE ORGANISMS

3827
03:07:32,683 --> 03:07:33,184
GETTING IN THERE AND STAYING

3828
03:07:33,184 --> 03:07:33,718
ALIVE SO THIS GOES BACK TO

3829
03:07:33,718 --> 03:07:34,352
STUDIES AT THE VERY BEGINNING OF

3830
03:07:34,352 --> 03:07:35,019
PROBIOTIC USE THE FIRST STUDY IS

3831
03:07:35,019 --> 03:07:35,853
PRESENTED HERE.

3832
03:07:35,853 --> 03:07:46,397
THEY GAVE PROBIOTIC STRAIN FOR 2

3833
03:07:49,333 --> 03:07:49,900
WEEKS AND THEN THEY CULTURE THAT

3834
03:07:49,900 --> 03:07:50,534
ORGANISM FROM THE STOOL AND THEY

3835
03:07:50,534 --> 03:07:51,168
HAD USE VERY SPECIFIC ANAEROBIC

3836
03:07:51,168 --> 03:07:51,769
CULTURES TO GET ACCURATE DATA

3837
03:07:51,769 --> 03:07:57,642
AND FOUND THAT YES LIVE BACTERIA

3838
03:07:57,642 --> 03:07:58,242
ARE IN THERE AND STAY IN THERE

3839
03:07:58,242 --> 03:07:58,876
FOR A LITTLE WHILE BUT THEN THEY

3840
03:07:58,876 --> 03:08:04,849
GRADUALLY DECREASE AFTER THE

3841
03:08:04,849 --> 03:08:05,416
INTRODUCTION OF ANTIBIOTICS.

3842
03:08:05,416 --> 03:08:06,017
WE HAVE ALL MOVED WELL BEYOND

3843
03:08:06,017 --> 03:08:10,087
THE USE OF CULTURES BUT THERE IS

3844
03:08:10,087 --> 03:08:10,721
BIAS IN ANY METHODOLOGY THAT YOU

3845
03:08:10,721 --> 03:08:11,656
HAVE SO FOR THE CULTURE -BASED

3846
03:08:11,656 --> 03:08:17,962
METHODS THOSE VERY OFTEN

3847
03:08:17,962 --> 03:08:18,562
ANAEROBES ARE HARD TO CULTURE

3848
03:08:18,562 --> 03:08:19,163
THEY ARE HARD TO PROCESS SO IT

3849
03:08:19,163 --> 03:08:23,167
IS PRONE TO NOT FINDING THINGS

3850
03:08:23,167 --> 03:08:32,510
AND WITH THE USE OF CULTURE

3851
03:08:32,510 --> 03:08:33,144
INDEPENDENT SEQUENCING THAT ALSO

3852
03:08:33,144 --> 03:08:33,744
HAS SOME BIAS ASSOCIATED 1 OF

3853
03:08:33,744 --> 03:08:34,345
THE QUESTIONS EARLY ON HIS ARE

3854
03:08:34,345 --> 03:08:39,684
WE JUST MEASURING DEAD?

3855
03:08:39,684 --> 03:08:40,317
IS THERE SOMETHING REALLY GOING

3856
03:08:40,317 --> 03:08:40,484
ON?

3857
03:08:40,484 --> 03:08:41,118
I THINK OVER TIME GIVEN THE FACT

3858
03:08:41,118 --> 03:08:48,292
WE SEE SUCH AN IMPACT ON BOTH

3859
03:08:48,292 --> 03:08:48,926
COMMUNITY STRUCTURE AND FUNCTION

3860
03:08:48,926 --> 03:08:49,493
AND THE ENGRAFTMENT THAT HAS

3861
03:08:49,493 --> 03:08:50,961
BEEN SHOWN TO CONTINUE ON PAST

3862
03:08:50,961 --> 03:08:54,065
THE USE OF ANTIBIOTICS WITH THE

3863
03:08:54,065 --> 03:08:57,768
ORGANISM YOU ARE USING CAN STAY

3864
03:08:57,768 --> 03:09:02,139
BEYOND THE STATE FOR MANY

3865
03:09:02,139 --> 03:09:02,373
MONTHS.

3866
03:09:02,373 --> 03:09:03,007
SO I WOULD SAY IN SUMMARY THEY

3867
03:09:03,007 --> 03:09:04,975
ARE ALIVE AND KICKING AND

3868
03:09:04,975 --> 03:09:15,286
STICKING IN THERE.

3869
03:09:16,821 --> 03:09:17,188
WHAT ARE THEY DOING?

3870
03:09:17,188 --> 03:09:17,688
HOW DO THEY IMPACT THIS

3871
03:09:17,688 --> 03:09:18,322
TRAJECTORY AND THIS PATTERN THAT

3872
03:09:18,322 --> 03:09:18,923
WE JUST HEARD PHIL TALK ABOUT?

3873
03:09:18,923 --> 03:09:19,457
THERE IS A LITTLE BIT OF

3874
03:09:19,457 --> 03:09:20,124
VARIATION IN THE DATA AND NOW IN

3875
03:09:20,124 --> 03:09:27,932
THE LAST FEW YEARS, AGAIN IT MAY

3876
03:09:27,932 --> 03:09:28,532
VARY DEPENDING ON THE ORGANISM

3877
03:09:28,532 --> 03:09:29,166
YOU ARE LOOKING AT THAT THERE IS

3878
03:09:29,166 --> 03:09:30,601
A THEME THAT YOU HEAR THROUG 

3879
03:09:30,601 --> 03:09:30,901
THROUGHOUT.

3880
03:09:30,901 --> 03:09:33,704
BUT OVERWHELMINGLY THE DATA

3881
03:09:33,704 --> 03:09:37,108
SHOWS THAT IT DOES ADVANCE

3882
03:09:37,108 --> 03:09:45,583
MATURATION.

3883
03:09:45,583 --> 03:09:46,183
THEY TEND TO BE THE DRIVERS OF

3884
03:09:46,183 --> 03:09:46,817
THAT AND ACCELERATE PROGRESSION

3885
03:09:46,817 --> 03:09:47,418
OF THE MATURATION OF THE GUT

3886
03:09:47,418 --> 03:09:50,654
MICRO BIOME.

3887
03:09:50,654 --> 03:09:59,296
THERE IS SOME DATA THAT SAYS IT

3888
03:09:59,296 --> 03:09:59,897
DOES NOT ADVANCE MATURATION IT

3889
03:09:59,897 --> 03:10:00,531
MOVES THINGS AROUND AND CHANGES

3890
03:10:00,531 --> 03:10:01,065
SPECIFIC BACTERIA BUT THAT

3891
03:10:01,065 --> 03:10:02,600
PATTERN OF PROGRESSION CONTIN 

3892
03:10:02,600 --> 03:10:02,867
CONTINUES.

3893
03:10:02,867 --> 03:10:05,703
I WILL GIVE YOU 1 EXAMPLE.

3894
03:10:05,703 --> 03:10:08,839
IT'S BUSY BUT IT IS AN EXAMPLE

3895
03:10:08,839 --> 03:10:19,283
OF THE MATURATION AFFECT.

3896
03:10:19,750 --> 03:10:20,317
CHRISTOPHER STEWART'S GROUP OUT

3897
03:10:20,317 --> 03:10:20,818
OF THE UK JUST RECENTLY

3898
03:10:20,818 --> 03:10:21,485
PUBLISHED AND THEY TOOK 123 VERY

3899
03:10:21,485 --> 03:10:22,553
LOW BIRTH WEIGHT BABIES WITH NO

3900
03:10:22,553 --> 03:10:25,022
PATHOLOGY.

3901
03:10:25,022 --> 03:10:25,656
IN FACT THEY WERE STUDYING OVER

3902
03:10:25,656 --> 03:10:26,257
A 10 YEAR PERIOD ALL BABIES IN

3903
03:10:26,257 --> 03:10:26,624
THE NICU.

3904
03:10:26,624 --> 03:10:36,167
FROM THAT GROUP PULLING 123

3905
03:10:36,167 --> 03:10:36,767
CASES OF SEPSIS TOOK ADVANTAGE

3906
03:10:36,767 --> 03:10:37,401
OF A NATURAL EXPERIMENT GOING ON

3907
03:10:37,401 --> 03:10:38,769
AT THE TIME.

3908
03:10:38,769 --> 03:10:41,405
THROUGH 2011 AND 2013 THEY DID

3909
03:10:41,405 --> 03:10:42,273
NOT USE ANY ANTIBIOTIC -- -- IN

3910
03:10:42,273 --> 03:10:45,276
A BIOTICS 2014 THROUGH 16 THEY

3911
03:10:45,276 --> 03:10:53,217
INTRODUCED TO ORGANISMS AND THEN

3912
03:10:53,217 --> 03:10:53,851
WHEN THAT PRODUCT WAS NO LONGER

3913
03:10:53,851 --> 03:10:54,318
AVAILABLE THEY MOVE TO

3914
03:10:54,318 --> 03:10:57,121
ADDITIONAL PRODUCT AND ADDED ON

3915
03:10:57,121 --> 03:11:07,631
THE SAME TO BASIS BUT THEN THE

3916
03:11:13,704 --> 03:11:14,171
FINAL PRODUCT ADDED A VERY

3917
03:11:14,171 --> 03:11:14,772
SPECIFIC ADDITIONAL SPECIES TO

3918
03:11:14,772 --> 03:11:15,372
WHAT THEY WERE SEEING SO THEN

3919
03:11:15,372 --> 03:11:15,973
THEY FOLLOWED THE INFANTS OVER

3920
03:11:15,973 --> 03:11:16,574
THE COURSE OVER THE FIRST 69

3921
03:11:16,574 --> 03:11:24,548
DAYS 0 THROUGH 69 COLLECTING

3922
03:11:24,548 --> 03:11:24,882
STOOL SAMPLES.

3923
03:11:24,882 --> 03:11:25,516
THEY FIRST TOOK ALL OF THE STOOL

3924
03:11:25,516 --> 03:11:26,851
SAMPLES AND WERE ABLE TO

3925
03:11:26,851 --> 03:11:30,421
CLASSIFY THE COMMUNITY TYPES

3926
03:11:30,421 --> 03:11:31,455
INTO 5 DISTINCT COMMUNITY

3927
03:11:31,455 --> 03:11:32,857
TYPES.

3928
03:11:32,857 --> 03:11:35,492
AND THEN THEY LOOKED AT THE

3929
03:11:35,492 --> 03:11:46,003
INFANTS AND HOW OVER TIME THEY

3930
03:11:46,770 --> 03:11:47,271
DEVELOP THEIR GUT MICROBIAL

3931
03:11:47,271 --> 03:11:47,838
COMMUNITY ACROSS ALL OF THE

3932
03:11:47,838 --> 03:11:48,439
DIFFERENT TIME COMPONENTS THE

3933
03:11:48,439 --> 03:11:52,109
INFANT STARTED OUT WITH THE

3934
03:11:52,109 --> 03:11:52,676
COMMUNITY TYPE I AND THAT IS

3935
03:11:52,676 --> 03:11:54,645
WHAT WE SAW THAT PHIL TALKED

3936
03:11:54,645 --> 03:11:58,315
ABOUT A LOT OF THE GRAM-POSITIVE

3937
03:11:58,315 --> 03:12:00,050
BACILLI WITH THE STAFF SPECIES

3938
03:12:00,050 --> 03:12:08,325
THAT WERE PRESENT AND IN THE

3939
03:12:08,325 --> 03:12:08,959
KNOW PROBIOTIC AREA THE INSTANCE

3940
03:12:08,959 --> 03:12:14,298
MATURED INTO A COMMUNITY TYPE

3941
03:12:14,298 --> 03:12:16,834
THAT IS DOMINATED BY GAMMA

3942
03:12:16,834 --> 03:12:27,011
BACTERIA.

3943
03:12:28,245 --> 03:12:28,779
AND THEN THEY INTRODUCED INTO

3944
03:12:28,779 --> 03:12:29,313
THE POPULATION THE USE OF

3945
03:12:29,313 --> 03:12:29,914
PROBIOTICS YOU CAN SEE A SHIFT

3946
03:12:29,914 --> 03:12:30,547
OF HOW THE INFANTS MOVE THROUGH

3947
03:12:30,547 --> 03:12:31,181
COMMUNITY MEMBERSHIP TOWARD THE

3948
03:12:31,181 --> 03:12:33,484
COMMUNITY TYPE 5 AND THIS IS

3949
03:12:33,484 --> 03:12:37,922
DISCRIMINATED BY THE PRESENCE OF

3950
03:12:37,922 --> 03:12:40,391
BACTERIA THAT WAS NOT EVEN

3951
03:12:40,391 --> 03:12:42,960
PRESENT IN THE PRODUCT THAT THEY

3952
03:12:42,960 --> 03:12:45,162
USE THEY TRY TO CULTURE THAT OUT

3953
03:12:45,162 --> 03:12:47,665
BUT IT'S NOW PRESENT AS WELL AS

3954
03:12:47,665 --> 03:12:50,734
INTO CAUCUS AND BYRON ELLA NOW A

3955
03:12:50,734 --> 03:12:57,374
LITTLE BIT CLOSER TO THE TERM

3956
03:12:57,374 --> 03:12:57,975
BREAST-FED BABY STOOL AND THEN

3957
03:12:57,975 --> 03:12:58,542
THEY FINALLY INTRODUCED THE

3958
03:12:58,542 --> 03:13:03,347
THIRD PRODUCT, THE COMMUNITY

3959
03:13:03,347 --> 03:13:05,649
PROFILE MOVED TOWARD A MORE

3960
03:13:05,649 --> 03:13:07,952
DOMINANT TYPE WHICH IS MUCH

3961
03:13:07,952 --> 03:13:17,795
GREATER DIVERSITY OF BACTERIA

3962
03:13:17,795 --> 03:13:18,429
AND LACTOBACILLI WHICH WAS MUCH

3963
03:13:18,429 --> 03:13:19,029
CLOSER STATISTICALLY TO A TERM

3964
03:13:19,029 --> 03:13:26,236
INFANT BEING FED BREASTMILK.

3965
03:13:26,236 --> 03:13:26,737
I THINK YOU CAN SAY THE

3966
03:13:26,737 --> 03:13:27,338
EVOLUTION OF THE GUT MICROBIAL

3967
03:13:27,338 --> 03:13:27,972
COMMUNITY VARIES BY THE PRODUCT

3968
03:13:27,972 --> 03:13:33,444
YOU ARE USING NOT ONLY GENUS BUT

3969
03:13:33,444 --> 03:13:33,978
SPECIES AND STRAIN IS VERY

3970
03:13:33,978 --> 03:13:38,382
IMPORTANT IN THE PROCESS AND IT

3971
03:13:38,382 --> 03:13:39,016
ACCELERATED MATURATION CLOSER TO

3972
03:13:39,016 --> 03:13:44,788
A TERM PROFILE.

3973
03:13:44,788 --> 03:13:45,389
SO REALLY WE ARE TALKING ABOUT

3974
03:13:45,389 --> 03:13:47,624
THIS TERRIBLE DISEASE

3975
03:13:47,624 --> 03:13:48,258
NECROTIZING ENTEROCOLITIS WHAT

3976
03:13:48,258 --> 03:13:53,197
DOES THAT HAVE TO DO WITH NEC?

3977
03:13:53,197 --> 03:13:54,264
I WILL GO BACK TO THE EARLIER

3978
03:13:54,264 --> 03:13:58,268
INFORMATION THAT WAS MENTIONED

3979
03:13:58,268 --> 03:13:58,902
ABOUT THE DIFFERENT SURVEYS AND

3980
03:13:58,902 --> 03:14:01,438
A COUPLE OF PEOPLE HAVE TALKED

3981
03:14:01,438 --> 03:14:09,546
ABOUT THE SURVEYS AS WELL.

3982
03:14:09,546 --> 03:14:10,080
THIS IS FROM 2023 A LOT OF

3983
03:14:10,080 --> 03:14:10,714
DIFFERENT PRODUCTS HE SAW WERE

3984
03:14:10,714 --> 03:14:14,918
BEING USED SO ON THE X AXIS IS A

3985
03:14:14,918 --> 03:14:15,853
DIFFERENT PRODUCT AND THEN THE

3986
03:14:15,853 --> 03:14:17,921
NUMBER OF NICU.

3987
03:14:17,921 --> 03:14:24,328
A LOT OF VARIATION AS TO WHAT

3988
03:14:24,328 --> 03:14:24,828
PRODUCTS ARE BEING USED.

3989
03:14:24,828 --> 03:14:29,566
LOOK AT THE TOP 3 TAKE A CLOSER

3990
03:14:29,566 --> 03:14:30,100
LOOK THE MOST COMMON IS A

3991
03:14:30,100 --> 03:14:40,544
COMBINATION OF FACTORS THE

3992
03:14:52,122 --> 03:14:52,556
SECOND THE VARIATIONS IN

3993
03:14:52,556 --> 03:14:53,090
ADDITION TO VARIATIONS OF

3994
03:14:53,090 --> 03:14:54,658
PRODUCTS LOTS OF VARIATION IN

3995
03:14:54,658 --> 03:14:55,025
ADMINISTRATION.

3996
03:14:55,025 --> 03:14:57,995
SOME OF THE NIC GAVE IT TO ALL

3997
03:14:57,995 --> 03:14:58,595
BABIES UNDER 35 WEEKS YOU CAN

3998
03:14:58,595 --> 03:15:04,001
SEE THE DISTRIBUTION BY WEEKS

3999
03:15:04,001 --> 03:15:05,569
SUMMIT 34, 33, 32 LOTS OF

4000
03:15:05,569 --> 03:15:06,837
VARIATIONS.

4001
03:15:06,837 --> 03:15:12,142
THE DIFFERENCES IN TERMS OF THE

4002
03:15:12,142 --> 03:15:13,510
FEEDING TYPE SOME GAVE IT TO

4003
03:15:13,510 --> 03:15:15,045
EVERYBODY SOME WAS JUST

4004
03:15:15,045 --> 03:15:20,851
BREASTMILK OR FORMULA AND SOME

4005
03:15:20,851 --> 03:15:24,922
PLACES GAVE IT AND PO ALSO

4006
03:15:24,922 --> 03:15:28,492
DIFFERENCES OF TIMING.

4007
03:15:28,492 --> 03:15:35,199
WHEN YOU TAKE THE TOP 3 LOOK AT

4008
03:15:35,199 --> 03:15:37,534
THE DATA FOR THE INDIVIDUAL

4009
03:15:37,534 --> 03:15:42,206
SPECIES THOSE INDIVIDUAL

4010
03:15:42,206 --> 03:15:42,840
PRODUCTS AND WE ARE LOOKING NOW

4011
03:15:42,840 --> 03:15:46,643
AT CLINICAL DATA AND LOOKING FOR

4012
03:15:46,643 --> 03:15:48,712
RANDOMIZED CONTROL TRIALS AND

4013
03:15:48,712 --> 03:15:59,256
GOOD EPIDEMIOLOGIC STUDIES THAT

4014
03:16:01,625 --> 03:16:02,192
DATA IS LESS ROBUST THAN WE WILL

4015
03:16:02,192 --> 03:16:02,659
SEE AND META-ANALYSIS.

4016
03:16:02,659 --> 03:16:03,260
IT DOES NOT MEAN THERE IS NOT

4017
03:16:03,260 --> 03:16:06,230
ADDITIONAL SAFETY DATA OUT THERE

4018
03:16:06,230 --> 03:16:06,897
OR ENGRAFTMENT DATA BUT THIS IS

4019
03:16:06,897 --> 03:16:07,464
PARTICULARLY FOCUSED ON THE

4020
03:16:07,464 --> 03:16:11,034
CLINICAL TRIALS.

4021
03:16:11,034 --> 03:16:11,635
SO IN THE FIRST CATEGORY THE

4022
03:16:11,635 --> 03:16:16,206
MOST COMMONLY USED THE LARGEST

4023
03:16:16,206 --> 03:16:18,142
RANDOMIZED CONTROLLED TRIALS FOR

4024
03:16:18,142 --> 03:16:23,914
THE USE OF PROBIOTICS IS OVER

4025
03:16:23,914 --> 03:16:24,948
1000 BABIES AND IT SHOWED A

4026
03:16:24,948 --> 03:16:28,418
54 PERCENT REDUCTION OF THE NEC

4027
03:16:28,418 --> 03:16:29,453
GREAT A VERY LOW BIRTH WEIGHT

4028
03:16:29,453 --> 03:16:30,988
BABIES.

4029
03:16:30,988 --> 03:16:38,962
IN THE SECOND TYPICALLY IT WAS

4030
03:16:38,962 --> 03:16:39,530
USED IN COMBINATION WITH 57

4031
03:16:39,530 --> 03:16:40,297
STUDIES USED IN VARIOUS

4032
03:16:40,297 --> 03:16:44,234
COMBINATIONS AND THERE IS A

4033
03:16:44,234 --> 03:16:47,137
STUDY A RETROSPECTIVE ANALYSIS

4034
03:16:47,137 --> 03:16:50,641
FROM 2014 WHICH HAD A HIGH

4035
03:16:50,641 --> 03:16:53,076
NUMBER OF BABIES ALMOST 500 THAT

4036
03:16:53,076 --> 03:16:56,413
SHOWED A DECREASE OF NEC ALONG

4037
03:16:56,413 --> 03:17:04,488
-- -- AMONG THE VLBW GROUP.

4038
03:17:04,488 --> 03:17:05,088
I KNOW 1 OF THOSE AUTHORS ARE

4039
03:17:05,088 --> 03:17:05,722
HERE SO THAT MAY COME UP LATER.

4040
03:17:05,722 --> 03:17:07,324
THEN THE THIRD MOST COMMON IS A

4041
03:17:07,324 --> 03:17:11,461
COMBINATION OF VARIOUS

4042
03:17:11,461 --> 03:17:17,301
COMBINATION OF CLINICAL STUDIES

4043
03:17:17,301 --> 03:17:17,868
THERE WAS 1 RANDOMIZED

4044
03:17:17,868 --> 03:17:21,872
CONTROLLED TRIAL IN 2022 WHICH

4045
03:17:21,872 --> 03:17:22,906
IS A VERY HIGH RISK RATIO BUT

4046
03:17:22,906 --> 03:17:25,642
VERY LARGE CONFIDENCE

4047
03:17:25,642 --> 03:17:26,743
INTERVALS.

4048
03:17:26,743 --> 03:17:28,779
ALSO ADDITIONAL STUDIES THAT

4049
03:17:28,779 --> 03:17:38,055
SHOW DECREASES OF RATES.

4050
03:17:38,055 --> 03:17:38,622
SO THE DATA IS VARIABLE ON A

4051
03:17:38,622 --> 03:17:39,256
SPECIFIC FORMULATION SO 1 OF THE

4052
03:17:39,256 --> 03:17:39,856
THINGS THAT WE DO IN THAT CASE

4053
03:17:39,856 --> 03:17:48,465
IS TRIED TO PULL THE DATA AND

4054
03:17:48,465 --> 03:17:48,966
LUMP IT TOGETHER TO GET

4055
03:17:48,966 --> 03:17:49,466
ADDITIONAL INFORMATION.

4056
03:17:49,466 --> 03:17:50,033
SO LOOKING AT THE SYSTEMATIC

4057
03:17:50,033 --> 03:17:55,439
REVIEWS OF META-ANALYSIS MANY

4058
03:17:55,439 --> 03:17:56,006
HAVE BEEN DONE AS THIS GRAPH

4059
03:17:56,006 --> 03:17:57,507
DEMONSTRATES AND THERE ARE LOTS

4060
03:17:57,507 --> 03:18:04,248
OF VERY GOOD STUDIES THROUGH

4061
03:18:04,248 --> 03:18:04,815
THIS ANALYSIS OVER THE YEARS

4062
03:18:04,815 --> 03:18:05,349
PARTICULARLY THE LAST FEW

4063
03:18:05,349 --> 03:18:12,823
YEARS.

4064
03:18:12,823 --> 03:18:13,457
I WANT TO USE OUR PLATFORM THAT

4065
03:18:13,457 --> 03:18:13,991
IS RELATIVELY CURRENT AND

4066
03:18:13,991 --> 03:18:14,691
INCLUSIVE OF ALL THE DIFFERENT

4067
03:18:14,691 --> 03:18:16,526
VARIOUS PROBIOTIC COMPONENTS

4068
03:18:16,526 --> 03:18:24,234
THAT EVALUATED FOR BIAS AND ALSO

4069
03:18:24,234 --> 03:18:24,868
INCLUDED A SENSITIVITY ANALYSIS

4070
03:18:24,868 --> 03:18:25,435
PULLING OUT JUST THE HIGHEST

4071
03:18:25,435 --> 03:18:35,712
QUALITY STUDIES.

4072
03:18:36,647 --> 03:18:37,214
SO I WILL USE THE REVIEW AS THE

4073
03:18:37,214 --> 03:18:37,781
BASE TO GET THROUGH SOME OF

4074
03:18:37,781 --> 03:18:38,248
THESE CLINICAL TRIALS.

4075
03:18:38,248 --> 03:18:38,849
JUST PUBLISHED 2023 IT MET ALL

4076
03:18:38,849 --> 03:18:43,553
MY CRITERIA AND VERY

4077
03:18:43,553 --> 03:18:44,187
SPECIFICALLY LOOKED AT ISSUES OF

4078
03:18:44,187 --> 03:18:44,688
DESIGN QUALITY AND STUDY

4079
03:18:44,688 --> 03:18:45,322
MUTATIONS USING THE 6 DIFFERENT

4080
03:18:45,322 --> 03:18:47,324
COMPONENTS SELECTION AND

4081
03:18:47,324 --> 03:18:55,032
NUTRITION BIAS AND IT INCLUDES

4082
03:18:55,032 --> 03:18:55,565
60 TRIALS WITH OVER 11000

4083
03:18:55,565 --> 03:18:55,799
BABIES.

4084
03:18:55,799 --> 03:19:00,637
A LOT OF BABIES.

4085
03:19:00,637 --> 03:19:01,271
I THINK WE HAVE SEEN THE SUMMARY

4086
03:19:01,271 --> 03:19:09,946
SLIDE EARLIER.

4087
03:19:09,946 --> 03:19:10,547
LOOKING AT NEC MORTALITY LATE

4088
03:19:10,547 --> 03:19:11,081
ONSET INFECTIONS AND FIRST

4089
03:19:11,081 --> 03:19:11,648
DESCRIBES IT IN TERMS OF THE

4090
03:19:11,648 --> 03:19:22,159
ABSOLUTE EFFECT SO 60 PER 1000

4091
03:19:27,731 --> 03:19:28,265
IS A RISK OF 6 PERCENT VERSUS

4092
03:19:28,265 --> 03:19:28,732
THE PROBIOTIC GROUP OF

4093
03:19:28,732 --> 03:19:29,266
3.3 PERCENT SO IN TERMS OF

4094
03:19:29,266 --> 03:19:29,833
GETTING AN IDEA OF WHAT THAT

4095
03:19:29,833 --> 03:19:30,334
RISK DIFFERENCES IN THE

4096
03:19:30,334 --> 03:19:30,967
MAGNITUDE OF THAT SOMETIMES THAT

4097
03:19:30,967 --> 03:19:31,535
IS HARD TO TELL IN THE RISK

4098
03:19:31,535 --> 03:19:31,802
RATIO.

4099
03:19:31,802 --> 03:19:32,436
IT IS 2.7 PERCENT WHICH WHEN THE

4100
03:19:32,436 --> 03:19:42,512
NUMBERS ARE FAIRLY LOW OVERA

4101
03:19:42,512 --> 03:19:43,013
OVERALL, CAN BE A FAIRLY

4102
03:19:43,013 --> 03:19:43,447
SIGNIFICANT IMPACT.

4103
03:19:43,447 --> 03:19:43,947
SHOWING A RISK RATIO OF

4104
03:19:43,947 --> 03:19:45,649
0.5436 PERCENT REDUCTION IN THE

4105
03:19:45,649 --> 03:19:50,287
RATE OF NEC FOR ALL CAUSE

4106
03:19:50,287 --> 03:19:52,823
MORTALITY AND THEN ON THE FAR

4107
03:19:52,823 --> 03:19:56,093
LEFT THAT RISK DIFFERENCES

4108
03:19:56,093 --> 03:20:06,603
1.5 PERCENT AND IT IS ABOUT 12

4109
03:20:07,037 --> 03:20:07,571
OR 23 PERCENT DECREASE IN RATE

4110
03:20:07,571 --> 03:20:08,205
AND AGAIN MUCH LOWER ONCE AGAIN

4111
03:20:08,205 --> 03:20:13,143
FOR LATE ONSET SEPSIS.

4112
03:20:13,143 --> 03:20:13,744
QUALITY OF THE EVIDENCE VARIED

4113
03:20:13,744 --> 03:20:14,778
AND THE OFFICE CONCLUSION IS

4114
03:20:14,778 --> 03:20:18,215
THAT PROBIOTICS MAY REDUCE THE

4115
03:20:18,215 --> 03:20:21,218
RISK OF NEC WITH LOW CERTAINTY.

4116
03:20:21,218 --> 03:20:31,428
IT PROBABLY REDUCES THE OVERALL

4117
03:20:31,428 --> 03:20:31,928
MORTALITY WITH MODERATE

4118
03:20:31,928 --> 03:20:32,529
CERTAINTY AND IT PROBABLY HAS

4119
03:20:32,529 --> 03:20:33,163
LITTLE OR NO EFFECT ON THE RISK

4120
03:20:33,163 --> 03:20:39,136
OF LATE ONSET SEPSIS WITH

4121
03:20:39,136 --> 03:20:39,569
MODERATE CERTAINTY.

4122
03:20:39,569 --> 03:20:41,671
SO HOW COULD IT BE WE HAVE 11000

4123
03:20:41,671 --> 03:20:44,274
BABIES ENROLLED IN THE STUDIES

4124
03:20:44,274 --> 03:20:45,475
AND WE HAVE ONLY HAVE THAT

4125
03:20:45,475 --> 03:20:52,516
CERTAINTY IN TERMS OF THE EFF 

4126
03:20:52,516 --> 03:20:52,749
EFFECT?

4127
03:20:52,749 --> 03:20:53,350
ONE OF THE CONCERNS RAISED WAS

4128
03:20:53,350 --> 03:20:55,018
THE CONCERN AROUND PUBLICATION

4129
03:20:55,018 --> 03:21:00,791
BIAS AND THE BOTTOM LINE IS IT

4130
03:21:00,791 --> 03:21:01,525
IS SUPPOSED TO BE SYMMETRIC IF

4131
03:21:01,525 --> 03:21:01,992
THERE'S NO EVIDENCE OF

4132
03:21:01,992 --> 03:21:11,802
PUBLICATION BIAS IT DOES HAVE A

4133
03:21:11,802 --> 03:21:12,436
SYMMETRY FAVORING PUBLICATION OF

4134
03:21:12,436 --> 03:21:13,069
POSITIVE STUDIES THAT SHOWED THE

4135
03:21:13,069 --> 03:21:13,703
TREATMENT EFFECT COMPARED TO THE

4136
03:21:13,703 --> 03:21:13,970
CONTROLS.

4137
03:21:13,970 --> 03:21:14,638
YOU CAN DO STATISTICAL ANALYSIS

4138
03:21:14,638 --> 03:21:20,043
AND THAT WAS SIGNIFICANT.

4139
03:21:20,043 --> 03:21:20,677
SO NOW LET'S TAKE A LOOK AT THE

4140
03:21:20,677 --> 03:21:31,054
LUMPING OF THESE DIFFERENT

4141
03:21:31,054 --> 03:21:31,621
PRODUCTS BY A GENUS LEVELS.

4142
03:21:31,621 --> 03:21:32,222
SO I WILL FOCUS ON THE 3 MOST

4143
03:21:32,222 --> 03:21:32,823
COMMONLY USED AND WHAT I HAVE

4144
03:21:32,823 --> 03:21:33,423
DONE AT THE TOP I JUST MADE IT

4145
03:21:33,423 --> 03:21:43,934
EASIER FOR ALL OF US TO SHOW A

4146
03:21:46,770 --> 03:21:47,337
COMPARISON BETWEEN THE PROBIOTIC

4147
03:21:47,337 --> 03:21:47,938
AND THE CONTROL THE NUMBERS OF

4148
03:21:47,938 --> 03:21:48,505
NEC CASES AND THE NUMBER OF

4149
03:21:48,505 --> 03:21:54,344
BABIES AND THE FINAL COMPILED

4150
03:21:54,344 --> 03:21:54,978
RISK RATIO AND FOR A COMBINATION

4151
03:21:54,978 --> 03:21:59,416
OF BACTERIA SPECIES THE RISK

4152
03:21:59,416 --> 03:22:00,417
RATIO WAS 0.36 WHICH WAS

4153
03:22:00,417 --> 03:22:04,554
SIGNIFICANT AND INCLUDED THIS

4154
03:22:04,554 --> 03:22:05,121
OTHER TRIAL AND WE WILL TALK

4155
03:22:05,121 --> 03:22:08,592
ABOUT THAT IN MORE DETAIL THE

4156
03:22:08,592 --> 03:22:11,228
SECOND MOST IS THE BACTERIA

4157
03:22:11,228 --> 03:22:15,031
SPECIES IN ISOLATION AS A SINGLE

4158
03:22:15,031 --> 03:22:17,367
ORGANISM PROBABLY DOUBLE THE

4159
03:22:17,367 --> 03:22:22,506
NUMBER OF SUBJECTS AND SHOWED

4160
03:22:22,506 --> 03:22:23,373
ALMOST 30 PERCENT DECREASE OF

4161
03:22:23,373 --> 03:22:33,750
NEC RISK AND STILL WAS

4162
03:22:34,518 --> 03:22:35,085
SIGNIFICANT AND IT CONTAINS THIS

4163
03:22:35,085 --> 03:22:35,685
PIPS TRIAL SO I POINT OUT THE

4164
03:22:35,685 --> 03:22:36,319
TRIALS PRIMARILY BECAUSE OF THE

4165
03:22:36,319 --> 03:22:38,455
QUALITY THEY PROVIDED THEY WERE

4166
03:22:38,455 --> 03:22:41,791
THE HIGHEST CASE NUMBERS OVER

4167
03:22:41,791 --> 03:22:50,267
1000 IN EACH SO IF YOU ARE ALL

4168
03:22:50,267 --> 03:22:50,767
GREEN YOU DON'T HAVE ANY

4169
03:22:50,767 --> 03:22:51,368
IDENTIFIED BIAS IN YOUR STUDY

4170
03:22:51,368 --> 03:22:55,372
YELLOW IS NOT SO GREAT AND

4171
03:22:55,372 --> 03:22:55,972
YELLOW IS PRETTY BAD THERE ARE

4172
03:22:55,972 --> 03:22:56,573
SOME SMALLER STUDIES THAT ARE

4173
03:22:56,573 --> 03:23:00,944
PRETTY GREEN BUT MUCH SMALLER

4174
03:23:00,944 --> 03:23:01,511
COMPARED TO THESE 2 SO LET'S

4175
03:23:01,511 --> 03:23:04,314
TAKE A CLOSER LOOK SO THIS IS

4176
03:23:04,314 --> 03:23:08,985
FROM THE UK USING DIFFERENT

4177
03:23:08,985 --> 03:23:11,054
BACTERIA 1 WAS IN AUSTRALIA AND

4178
03:23:11,054 --> 03:23:21,097
NEW ZEALAND USING A COMBINATION

4179
03:23:21,097 --> 03:23:21,798
THE PRIMARY OUTCOME OF PIPS WAS

4180
03:23:21,798 --> 03:23:22,432
FOCUSED ON A COMPOSITE OUTCOME

4181
03:23:22,432 --> 03:23:30,707
WHERE AS THOSE THAT WERE LOOKING

4182
03:23:30,707 --> 03:23:31,274
AT LATE ONSET SEPSIS WAS THE

4183
03:23:31,274 --> 03:23:31,875
PRIMARY OUTCOME THE PIPS TRIAL

4184
03:23:31,875 --> 03:23:32,475
FOUND NO DIFFERENCE EITHER IN

4185
03:23:32,475 --> 03:23:39,683
THE PRIMARY OUTCOME OR NEC THERE

4186
03:23:39,683 --> 03:23:40,317
WAS NO DIFFERENCE OF LATE ONSET

4187
03:23:40,317 --> 03:23:40,951
SEPSIS OR MORTALITY BUT THEY DID

4188
03:23:40,951 --> 03:23:43,420
FIND A DECREASE OF NEC YOU CAN

4189
03:23:43,420 --> 03:23:44,387
SEE THAT FOR VERY LOW BIRTH

4190
03:23:44,387 --> 03:23:46,856
WEIGHT BABIES AGAIN IT WAS SEEN

4191
03:23:46,856 --> 03:23:51,595
WITH THE META-ANALYSIS AND FOR

4192
03:23:51,595 --> 03:23:52,529
THE EXTREME LOW BIRTH WEIGHT

4193
03:23:52,529 --> 03:23:56,600
BABIES THEY WERE ABLE TO HAVE NO

4194
03:23:56,600 --> 03:23:58,468
SIGNIFICANT DIFFERENCE WITH

4195
03:23:58,468 --> 03:24:04,074
ENCOMPASSING AND THEY HAD OVER

4196
03:24:04,074 --> 03:24:04,674
500 BABIES ARE NEARLY 500 AND

4197
03:24:04,674 --> 03:24:11,781
EACH OF THE STUDIES.

4198
03:24:11,781 --> 03:24:12,315
1 OF THE THINGS WE HEARD A

4199
03:24:12,315 --> 03:24:12,949
LITTLE BIT ABOUT EARLIER IN THE

4200
03:24:12,949 --> 03:24:13,550
DAY IS CROSSOVER THAT WHEN YOU

4201
03:24:13,550 --> 03:24:14,684
GIVE THE PROBIOTIC NOT ONLY

4202
03:24:14,684 --> 03:24:20,256
OTHER TREATED GROUPS GOING TO

4203
03:24:20,256 --> 03:24:20,857
HAVE A BIT YOU WILL HAVE IT IN

4204
03:24:20,857 --> 03:24:21,491
THE CONTROLS AS WELL AND IN THE

4205
03:24:21,491 --> 03:24:24,728
PIPS STUDY 35 PERCENT OF THE

4206
03:24:24,728 --> 03:24:30,100
CONTROLS WERE COLONIZED WITH THE

4207
03:24:30,100 --> 03:24:30,367
ORGANISM.

4208
03:24:30,367 --> 03:24:30,967
THIS IS THE ONLY STUDY I FOUND

4209
03:24:30,967 --> 03:24:34,371
THAT ACTUALLY TRIED TO ADDRESS

4210
03:24:34,371 --> 03:24:36,940
THIS ISSUE AND WE CATEGORIZE THE

4211
03:24:36,940 --> 03:24:40,844
CHILDREN BY THEIR COLONIZATION

4212
03:24:40,844 --> 03:24:44,547
STATUS.

4213
03:24:44,547 --> 03:24:45,181
AND THEY FOUND NO DIFFERENCE IN

4214
03:24:45,181 --> 03:24:47,684
THE RISK OF NEC.

4215
03:24:47,684 --> 03:24:52,589
SO THEN THE LAST CATEGORY OF

4216
03:24:52,589 --> 03:24:56,259
ORGANISMS COMBINED WITH

4217
03:24:56,259 --> 03:24:57,060
LACTOBACILLUS SHOWS A

4218
03:24:57,060 --> 03:25:02,732
SIGNIFICANT DECREASE FOR NEC.

4219
03:25:02,732 --> 03:25:03,299
NO EFFECTS ON THE REMAINING

4220
03:25:03,299 --> 03:25:08,004
ORGANISMS UP ON THE SLIDE IF YOU

4221
03:25:08,004 --> 03:25:08,605
TAKE THE STUDIES AND PUT THEM

4222
03:25:08,605 --> 03:25:10,573
TOGETHER FOR VERY LOW BIRTH

4223
03:25:10,573 --> 03:25:14,911
WEIGHT BABIES THOSE WITH ALMOST

4224
03:25:14,911 --> 03:25:15,912
A 50 PERCENT RISK OF AN EC THEN

4225
03:25:15,912 --> 03:25:25,855
YOU CAN SEE THOSE INTERVALS AND

4226
03:25:25,855 --> 03:25:26,456
IT IS SOMEWHAT REASSURING THAT

4227
03:25:26,456 --> 03:25:27,090
THE OVERALL AVERAGE RATE OF NEC

4228
03:25:27,090 --> 03:25:27,691
WAS 16 WHAT ARE THE CRITICISMS

4229
03:25:27,691 --> 03:25:28,291
IS THAT THE CONTROL GROUP HAS

4230
03:25:28,291 --> 03:25:28,958
SUCH A HIGH RATE OF NEC - - OF

4231
03:25:28,958 --> 03:25:31,094
NEC THEY WERE NOT MEASURING IT

4232
03:25:31,094 --> 03:25:32,162
CORRECTLY BUT AT LEAST IN THIS

4233
03:25:32,162 --> 03:25:35,398
COMBINED ANALYSIS IT IS SIMILAR

4234
03:25:35,398 --> 03:25:45,575
TO WHAT WE WOULD HAVE EXPECTED.

4235
03:25:45,575 --> 03:25:46,209
SO NOW THEY PULLED OUT ALL THE

4236
03:25:46,209 --> 03:25:46,743
STUDIES THAT WERE HIGHEST

4237
03:25:46,743 --> 03:25:47,377
QUALITY AND THEY LOOKED AT THOSE

4238
03:25:47,377 --> 03:25:50,146
AND NOW THEY ARE COMBINING ALL

4239
03:25:50,146 --> 03:25:55,752
THE DIFFERENT PROBIOTICS AND THE

4240
03:25:55,752 --> 03:25:56,419
IMPACT DROPS BUT IT DOES REMAIN

4241
03:25:56,419 --> 03:25:57,053
SIGNIFICANT WITH THE RISK RATIO

4242
03:25:57,053 --> 03:26:01,558
OF 0.7.

4243
03:26:01,558 --> 03:26:02,092
AND FOR MORTALITY OVERALL

4244
03:26:02,092 --> 03:26:09,966
MORTALITY VERY LOW BIRTH WEIGHT

4245
03:26:09,966 --> 03:26:10,600
I DID HAVE A 23 PERCENT DECREASE

4246
03:26:10,600 --> 03:26:11,201
WHICH WAS LOST IN SENSITIVITY

4247
03:26:11,201 --> 03:26:14,671
ANALYSIS AND NOT EVIDENT WITH

4248
03:26:14,671 --> 03:26:15,305
LOW BIRTH WEIGHT BUT LATE ONSET

4249
03:26:15,305 --> 03:26:19,075
SEPSIS NO SINGLE 1 GROUP SHOWING

4250
03:26:19,075 --> 03:26:20,009
AND AFFECT THE OVERALL DECREASE

4251
03:26:20,009 --> 03:26:26,249
WAS 11 PERCENT LOSS TO THE

4252
03:26:26,249 --> 03:26:26,883
SENSITIVITY ANALYSIS NOT EVIDENT

4253
03:26:26,883 --> 03:26:27,417
IN THE EXTREMELY LOW BIRTH

4254
03:26:27,417 --> 03:26:28,752
WEIGHT AND IN THIS GROUP OF

4255
03:26:28,752 --> 03:26:29,953
STUDIES NO ADVERSE EVENTS WERE

4256
03:26:29,953 --> 03:26:34,290
REPORTED.

4257
03:26:34,290 --> 03:26:34,924
LET'S PULL OUT THE EXTREMELY LOW

4258
03:26:34,924 --> 03:26:39,629
BIRTH WEIGHT BABIES BECAUSE WHO

4259
03:26:39,629 --> 03:26:40,930
GETS NEC UNDER 1000 GRAMS THEY

4260
03:26:40,930 --> 03:26:44,033
HAVE THE HIGHEST RATE NOT JUST

4261
03:26:44,033 --> 03:26:50,106
HAVING NEC BUT THE HIGHEST RATE

4262
03:26:50,106 --> 03:26:50,440
OF MORTALITY.

4263
03:26:50,440 --> 03:26:51,074
WHEN YOU LOOK AT THE STUDIES AT

4264
03:26:51,074 --> 03:26:55,311
EACH GENUS EVALUATED THERE WAS

4265
03:26:55,311 --> 03:26:55,945
NO SIGNIFICANT IMPACT ON NEC AND

4266
03:26:55,945 --> 03:26:57,781
WHEN YOU PUT THEM TOGETHER THE

4267
03:26:57,781 --> 03:27:08,258
RISK RATIO IS 0.92 WITH THE

4268
03:27:09,225 --> 03:27:09,793
CONFIDENCE INTERVAL OF 1 SO FOR

4269
03:27:09,793 --> 03:27:10,326
EXTREMELY LOW BIRTH WEIGHT

4270
03:27:10,326 --> 03:27:10,860
BABIES UNDER 1000 GRAMS NO

4271
03:27:10,860 --> 03:27:11,427
EFFECT LATE ONSET SEPSIS OR

4272
03:27:11,427 --> 03:27:12,262
MORTALITY.

4273
03:27:12,262 --> 03:27:16,866
NOW I WILL GO BACK TO THE REAL

4274
03:27:16,866 --> 03:27:20,203
WORLD OUT OF THESE CONTROL

4275
03:27:20,203 --> 03:27:26,843
TRIALS BACK TO A STUDY PUBLISHED

4276
03:27:26,843 --> 03:27:27,377
OUT OF THE VERMONT OXFORD

4277
03:27:27,377 --> 03:27:28,011
NETWORK OVER 300,000 BABIES AND

4278
03:27:28,011 --> 03:27:35,385
THEY LOOKED AT THE YEAR 2012

4279
03:27:35,385 --> 03:27:35,919
THROUGH 2019 AND THEY WERE

4280
03:27:35,919 --> 03:27:36,553
COMPARING ESTIMATES OF CHANGE OF

4281
03:27:36,553 --> 03:27:40,723
ANY SEE OUTCOME BY YEAR IN

4282
03:27:40,723 --> 03:27:41,191
HOSPITALS THAT ADOPTED

4283
03:27:41,191 --> 03:27:43,126
PROBIOTICS AND THOSE THAT DID

4284
03:27:43,126 --> 03:27:45,895
NOT.

4285
03:27:45,895 --> 03:27:55,605
AND OF THE OUTCOMES NEC

4286
03:27:55,605 --> 03:27:56,206
MORTALITY IN LATE ONSET SEPSIS

4287
03:27:56,206 --> 03:27:56,773
THE ONLY 1 THAT YOU CAN SEE

4288
03:27:56,773 --> 03:27:57,407
GRAPHICALLY IS A DECREASE OF NEC

4289
03:27:57,407 --> 03:28:01,845
RATES AND 18 PERCENT AND EACH OF

4290
03:28:01,845 --> 03:28:05,582
THESE ARE REGRESSION

4291
03:28:05,582 --> 03:28:06,416
COEFFICIENTS ACCOUNTING FOR 6

4292
03:28:06,416 --> 03:28:09,586
DEFECTS OF HOSPITAL, TIME AND

4293
03:28:09,586 --> 03:28:14,591
THE CHARACTERISTICS THEY DID NOT

4294
03:28:14,591 --> 03:28:18,228
ACCOUNT FOR TEMPORAL CHANGES IN

4295
03:28:18,228 --> 03:28:22,098
HOSPITAL.

4296
03:28:22,098 --> 03:28:22,632
THE ASSUMPTION WAS THAT IF

4297
03:28:22,632 --> 03:28:23,233
PROBIOTICS WERE NOT INTRODUCED

4298
03:28:23,233 --> 03:28:30,907
THEN THEY WOULD HAVE MAINTAINED

4299
03:28:30,907 --> 03:28:31,507
THE SAME TRAJECTORY OVER THAT

4300
03:28:31,507 --> 03:28:31,808
TIME PERIOD.

4301
03:28:31,808 --> 03:28:32,408
WE COULD ARGUE IF THAT IS TRUE

4302
03:28:32,408 --> 03:28:37,981
OR FALSE BUT THEY DID INDICATE

4303
03:28:37,981 --> 03:28:38,548
THESE TRENDS OVER TIME WERE

4304
03:28:38,548 --> 03:28:39,148
RELATIVELY STABLE PRIOR TO THE

4305
03:28:39,148 --> 03:28:45,421
USE OF PROBIOTICS AND THEY FOUND

4306
03:28:45,421 --> 03:28:45,955
THE ODDS RATIO 0.82 AND NO

4307
03:28:45,955 --> 03:28:54,831
IMPACT OF SEPSIS OR MORTALITY.

4308
03:28:54,831 --> 03:28:55,398
TO MAKE IT EASIER TO COMPARE

4309
03:28:55,398 --> 03:28:55,965
THERE IS CONVERSION TO RISK

4310
03:28:55,965 --> 03:28:56,766
RATIO THE NUMBERS ARE A LITTLE

4311
03:28:56,766 --> 03:29:07,277
DIFFERENT AND THE REVIEW RISK

4312
03:29:13,449 --> 03:29:14,017
RATIO FOR VERY LOW BIRTH WEIGHT

4313
03:29:14,017 --> 03:29:14,484
BABIES IS 0.5 FOR THE

4314
03:29:14,484 --> 03:29:15,118
SENSITIVITY ANALYSIS IS 0.7 AND

4315
03:29:15,118 --> 03:29:15,718
AN EXTREMELY LOW BIRTH WEIGHT

4316
03:29:15,718 --> 03:29:16,252
BABIES 0.92 IN THE VERMONT

4317
03:29:16,252 --> 03:29:18,087
OXFORD STUDY THE RISK RATIO WAS

4318
03:29:18,087 --> 03:29:18,588
MORE SIMILAR TO WHAT WAS

4319
03:29:18,588 --> 03:29:20,657
REPORTED ON THE SENSITIVITY

4320
03:29:20,657 --> 03:29:23,259
ANALYSIS AND ON THE COMBINED LOW

4321
03:29:23,259 --> 03:29:26,029
BIRTH WEIGHT OUTCOME ANALYSIS.

4322
03:29:26,029 --> 03:29:29,365
AND AGAIN NO DIFFERENCE FOUND

4323
03:29:29,365 --> 03:29:38,608
FOR EXTREMELY VLBW BABIES SO THE

4324
03:29:38,608 --> 03:29:39,175
BENEFIT WAS SMALLER THAT WAS

4325
03:29:39,175 --> 03:29:39,709
REPORTED IN META-ANALYSIS.

4326
03:29:39,709 --> 03:29:40,243
IT WAS SIMILAR TO WHAT WAS

4327
03:29:40,243 --> 03:29:43,079
EVIDENT IN THE SENSITIVITY

4328
03:29:43,079 --> 03:29:43,346
ANALYSIS.

4329
03:29:43,346 --> 03:29:50,386
BUT THE EVIDENCE FOR EXTREMELY

4330
03:29:50,386 --> 03:29:50,920
VLBW BABIES WAS WE CANNOT

4331
03:29:50,920 --> 03:29:51,220
SIGNIFICANT.

4332
03:29:51,220 --> 03:29:51,821
IT ALSO HIGHLIGHTS THE NEED TO

4333
03:29:51,821 --> 03:29:56,192
MONITOR PROBIOTICS AS THEY MOVE

4334
03:29:56,192 --> 03:29:57,126
OUT OF THESE TIGHTLY CONTROLLED

4335
03:29:57,126 --> 03:29:58,561
CLINICAL TRIALS TO CONTINUE TO

4336
03:29:58,561 --> 03:30:06,502
EVALUATE THEIR EFFICIENCY AND

4337
03:30:06,502 --> 03:30:06,736
EFFECT.

4338
03:30:06,736 --> 03:30:07,203
SO WHAT IS COMING UP?

4339
03:30:07,203 --> 03:30:07,837
WENT TO CLINICAL TRIALS.GOV AND

4340
03:30:07,837 --> 03:30:10,506
I PULLED OUT NOT EVERY SINGLE

4341
03:30:10,506 --> 03:30:11,140
STUDY THAT AT LEAST HAD TO POST

4342
03:30:11,140 --> 03:30:18,481
IN THE LAST 10 YEARS THEY WERE

4343
03:30:18,481 --> 03:30:19,115
RECRUITING ARE NOT YET STARTING

4344
03:30:19,115 --> 03:30:22,819
TO RECRUIT OR RECENTLY COMPLETED

4345
03:30:22,819 --> 03:30:26,622
THESE ARE THE STUDIES THAT WERE

4346
03:30:26,622 --> 03:30:28,825
PRESENT AND THE LARGEST STUDY

4347
03:30:28,825 --> 03:30:34,130
1600 BABIES IS IN THE

4348
03:30:34,130 --> 03:30:34,697
NETHERLANDS AND SPECIFICALLY

4349
03:30:34,697 --> 03:30:36,699
TARGETS BABIES BETWEEN 22 AND 28

4350
03:30:36,699 --> 03:30:42,572
WEEKS THE END DATE IS SLATED

4351
03:30:42,572 --> 03:30:42,939
2026.

4352
03:30:42,939 --> 03:30:45,475
THERE IS AN ADDITIONAL STUDY IN

4353
03:30:45,475 --> 03:30:47,810
PAKISTAN WITH SAFETY AND

4354
03:30:47,810 --> 03:30:51,647
TOLERABILITY STUDY.

4355
03:30:51,647 --> 03:30:54,684
IN ADDITION THERE ARE MANY

4356
03:30:54,684 --> 03:31:00,823
PRIVATE COMPANIES AS WELL AS

4357
03:31:00,823 --> 03:31:01,391
ACADEMIC CENTERS WORKING ON

4358
03:31:01,391 --> 03:31:02,025
ENGINEERING WHICH YOU DON'T HAVE

4359
03:31:02,025 --> 03:31:06,362
TIME TO GO INTO THE POTENTIALLY

4360
03:31:06,362 --> 03:31:13,469
ARE SAFER AND MORE EFFECTIVE.

4361
03:31:13,469 --> 03:31:14,070
I WILL SKIP MY SUMMARY FOR THE

4362
03:31:14,070 --> 03:31:14,404
SAKE OF TIME.

4363
03:31:14,404 --> 03:31:14,871
WE HAVE ALL HEARD IT.

4364
03:31:14,871 --> 03:31:18,741
WEIGH THE RISKS AND BENEFITS SO

4365
03:31:18,741 --> 03:31:19,342
I WILL END WITH THE THANK YOU

4366
03:31:19,342 --> 03:31:20,676
FOR ALL OF THE FAMILIES WHO HAVE

4367
03:31:20,676 --> 03:31:22,678
PARTICIPATED.

4368
03:31:22,678 --> 03:31:25,248
WITHOUT THEM WE WOULD KNOW

4369
03:31:25,248 --> 03:31:30,353
NOTHING AND YOU REALLY DO MAKE

4370
03:31:30,353 --> 03:31:30,820
IT BETTER FOR THE NEXT

4371
03:31:30,820 --> 03:31:31,421
GENERATION OF BABIES TO COME.

4372
03:31:31,421 --> 03:31:31,754
THANK YOU.

4373
03:31:31,754 --> 03:31:41,931
[APPLAUSE]

4374
03:31:43,466 --> 03:31:44,000
>> THANK YOU DOCTOR WARNER
WE

4375
03:31:44,000 --> 03:31:54,544
APPRECIATE YOUR PRESENTATION OF

4376
03:31:56,279 --> 03:31:56,779
NEXT PROFESSOR OF PEDIATRICS

4377
03:31:56,779 --> 03:31:57,380
DIVISION OF INFECTIOUS DISEASE

4378
03:31:57,380 --> 03:31:58,014
AT THE SCHOOL OF MEDICINE AND WE

4379
03:31:58,014 --> 03:31:58,614
WILL TALK ABOUT CLINICAL TRIAL

4380
03:31:58,614 --> 03:31:59,182
DESIGN CONSIDERATIONS IN THE

4381
03:31:59,182 --> 03:32:04,687
NICU.

4382
03:32:04,687 --> 03:32:05,288
>> THANK YOU VERY MUCH AND
TO

4383
03:32:05,288 --> 03:32:05,788
THE ORGANIZERS FOR THIS

4384
03:32:05,788 --> 03:32:06,089
OPPORTUNITY.

4385
03:32:06,089 --> 03:32:10,660
SINCE MY TIME WAS CHANGED I TOOK

4386
03:32:10,660 --> 03:32:11,227
THE LIBERTY OF CHANGING THE

4387
03:32:11,227 --> 03:32:11,427
TITLE.

4388
03:32:11,427 --> 03:32:14,897
HOPEFULLY IN THE NEXT 20 MINUTES

4389
03:32:14,897 --> 03:32:16,532
I CAN CONVINCE YOU OF THE

4390
03:32:16,532 --> 03:32:18,868
CHALLENGES AND MANY OF THEM HAVE

4391
03:32:18,868 --> 03:32:22,672
ALREADY BEEN DISCUSSED AS WELL.

4392
03:32:22,672 --> 03:32:26,509
AS MENTIONED I HAVE THE

4393
03:32:26,509 --> 03:32:29,278
PRIVILEGE OF WORKING WITH

4394
03:32:29,278 --> 03:32:32,982
MR. PATEL FOR MANY YEARS AND

4395
03:32:32,982 --> 03:32:35,551
ALSO 1 OF THE INFECTIOUS DISEASE

4396
03:32:35,551 --> 03:32:38,921
FELLOWS SO WE ARE PROUD OF HIS

4397
03:32:38,921 --> 03:32:49,332
ACCOMPLISHMENTS.

4398
03:32:49,332 --> 03:32:49,866
AND I WILL TALK ABOUT 2 THINGS

4399
03:32:49,866 --> 03:32:50,466
ABOUT DOING CLINICAL TRIALS IN

4400
03:32:50,466 --> 03:32:53,769
THE NICU AND ALSO PREPARING FOR

4401
03:32:53,769 --> 03:32:57,940
JOE'S TALK OF THE CHALLENGES OF

4402
03:32:57,940 --> 03:32:59,809
USING LIVE BIOTHERAPEUTICS AND

4403
03:32:59,809 --> 03:33:04,247
DOING STUDIES WITH THOSE.

4404
03:33:04,247 --> 03:33:06,816
DISCLOSURES RECEIVING TRAVEL

4405
03:33:06,816 --> 03:33:09,585
SUPPORT THE ASSOCIATION FOR

4406
03:33:09,585 --> 03:33:17,627
PROBIOTICS AND PREBIOTIC'S AND

4407
03:33:17,627 --> 03:33:18,227
THAT RELATIONSHIP HAS ENDED AS

4408
03:33:18,227 --> 03:33:18,828
WITH OTHER SPEAKERS THE VIEWS

4409
03:33:18,828 --> 03:33:20,730
EXPRESSED ARE MY OWN AND DO NOT

4410
03:33:20,730 --> 03:33:31,274
REPRESENT THOSE OF MY EMPLOYER.

4411
03:33:33,109 --> 03:33:37,446
AND SO WE HAVE REALLY LEARNED

4412
03:33:37,446 --> 03:33:38,047
WHAT WE REALLY NEED IS TO HELP

4413
03:33:38,047 --> 03:33:41,551
INFORM DECISION-MAKING.

4414
03:33:41,551 --> 03:33:43,186
OFTEN TIMES GETTING THAT CAN BE

4415
03:33:43,186 --> 03:33:51,160
CHALLENGING AND THAT HAS BEEN

4416
03:33:51,160 --> 03:33:58,434
EXPRESSED.

4417
03:33:58,434 --> 03:33:59,068
AND ALSO TO HAVE A STUDY DESIGN

4418
03:33:59,068 --> 03:33:59,669
FLEXIBILITY 1 OF THE MESSAGES

4419
03:33:59,669 --> 03:34:02,471
THEY WANT TO LEAVE YOU WITH.

4420
03:34:02,471 --> 03:34:04,774
AND TO THINK OF THE GOLD

4421
03:34:04,774 --> 03:34:11,380
STANDARD AND DEVELOPING

4422
03:34:11,380 --> 03:34:17,420
INFORMATION AND IT IS EXCITING

4423
03:34:17,420 --> 03:34:18,020
WITH NEW LIFE BIOTHERAPEUTICS

4424
03:34:18,020 --> 03:34:18,588
PRODUCTS ALSO ABOUT NEW AND

4425
03:34:18,588 --> 03:34:20,056
CHALLENGING WAYS OF DOING

4426
03:34:20,056 --> 03:34:22,425
STUDIES.

4427
03:34:22,425 --> 03:34:23,693
OFTEN TIMES ENROLLMENTS ARE TIME

4428
03:34:23,693 --> 03:34:30,866
SENSITIVE UNFORTUNATELY YOU HAVE

4429
03:34:30,866 --> 03:34:31,500
A VERY COMPLEX INFORMED CONSENT

4430
03:34:31,500 --> 03:34:32,001
PROCESS THAT CAN BE VERY

4431
03:34:32,001 --> 03:34:33,869
CHALLENGING FOR FAMILIES AS

4432
03:34:33,869 --> 03:34:41,844
WELL.

4433
03:34:41,844 --> 03:34:44,447
AND THEN WE DO HAVE THE

4434
03:34:44,447 --> 03:34:45,081
PRIVILEGE OF FOLLOWING BABIES

4435
03:34:45,081 --> 03:34:51,454
FOR A LONG PERIOD OF TIME SO WE

4436
03:34:51,454 --> 03:34:52,688
COULD LOSE TOUCH AFTER THEY ARE

4437
03:34:52,688 --> 03:34:54,023
TRANSFERRED FROM CENTER TO

4438
03:34:54,023 --> 03:34:56,058
CENTER THAT ALSO RELATES TO

4439
03:34:56,058 --> 03:35:01,464
LONG-TERM FOLLOW-UP.

4440
03:35:01,464 --> 03:35:11,807
AND WITH THE ENDPOINTS.

4441
03:35:11,807 --> 03:35:12,308
AND THOSE STATISTICS ARE

4442
03:35:12,308 --> 03:35:12,875
CHALLENGING AND THEN ANOTHER

4443
03:35:12,875 --> 03:35:13,476
HUGE CHALLENGES ADVERSE EVENT

4444
03:35:13,476 --> 03:35:16,112
ADJUDICATION.

4445
03:35:16,112 --> 03:35:17,680
AND SOMETHING THAT TRANSPIRES AS

4446
03:35:17,680 --> 03:35:20,650
THE ADVERSE EVENT OR IS IT

4447
03:35:20,650 --> 03:35:22,451
SOMETHING THAT IS RELATED TO THE

4448
03:35:22,451 --> 03:35:26,522
UNDERLYING POST?

4449
03:35:26,522 --> 03:35:27,123
WE SPENT A LOT OF TIME TALKING

4450
03:35:27,123 --> 03:35:31,460
ABOUT DEFINITIONS SO WHEN WE ARE

4451
03:35:31,460 --> 03:35:32,995
CONDUCTING STUDIES IT'S

4452
03:35:32,995 --> 03:35:39,001
IMPORTANT TO KNOW THE IMPORTANCE

4453
03:35:39,001 --> 03:35:45,808
OF USING THERAPEUTIC THAT HAS

4454
03:35:45,808 --> 03:35:56,118
DIFFERENT IMPACTS.

4455
03:35:57,186 --> 03:35:57,653
AND WITH THE MEASUREMENT

4456
03:35:57,653 --> 03:35:58,220
APPROACHES IN TERMS OF

4457
03:35:58,220 --> 03:36:06,696
OUTCOMES.

4458
03:36:06,696 --> 03:36:07,330
AND THEN WHAT WE WANT TO SHOW IS

4459
03:36:07,330 --> 03:36:16,439
A THERAPEUTIC BENEFIT AND THAT

4460
03:36:16,439 --> 03:36:26,949
REQUIRES INVALIDATED EFFICACY.

4461
03:36:29,885 --> 03:36:30,453
AND THERE IS SOME HOPE SO I WANT

4462
03:36:30,453 --> 03:36:31,087
TO MENTION SPECIFICALLY RELATED

4463
03:36:31,087 --> 03:36:31,754
TO ADVERSE EVENTS WHICH SEEMS TO

4464
03:36:31,754 --> 03:36:37,860
BE AN IMPORTANT CHALLENGE AND

4465
03:36:37,860 --> 03:36:39,295
THE ADVERSE EVENTS WAS DEVELOPED

4466
03:36:39,295 --> 03:36:41,864
IN 2019 BY THE INTERNATIONAL

4467
03:36:41,864 --> 03:36:46,669
NADEL CONSORTIUM AND BASICALLY

4468
03:36:46,669 --> 03:36:51,907
IT WAS A SCALE DEVELOPED WITH

4469
03:36:51,907 --> 03:36:53,109
THE VALIDATION AND BASICALLY TO

4470
03:36:53,109 --> 03:36:57,380
ASSESS THE IMPACT OF VARIABILITY

4471
03:36:57,380 --> 03:37:02,585
AND WHAT THEY DID WAS DEVELOP

4472
03:37:02,585 --> 03:37:13,129
THIS TO ASSESS RELIABILITY THAT

4473
03:37:13,396 --> 03:37:14,463
IS SHOWN WITH THE NICU

4474
03:37:14,463 --> 03:37:17,500
INTERNATIONALLY.

4475
03:37:17,500 --> 03:37:20,836
AND WITH THE TRIAL PROTOCOLS BUT

4476
03:37:20,836 --> 03:37:25,808
IT'S NOT COMPLETE THE PLANS TO

4477
03:37:25,808 --> 03:37:27,610
FURTHER REFINE AND STANDARDIZE

4478
03:37:27,610 --> 03:37:30,946
WITH ADDITIONAL COVERAGE.

4479
03:37:30,946 --> 03:37:32,515
THIS SLIDE YOU SHOWS A

4480
03:37:32,515 --> 03:37:39,722
SCREENSHOT TO HAVE A DEFINITION

4481
03:37:39,722 --> 03:37:40,389
OF NECROTIZING ENTEROCOLITIS FOR

4482
03:37:40,389 --> 03:37:46,629
ADVERSE EVENTS SO THIS IS FROM

4483
03:37:46,629 --> 03:37:47,263
THE ORIGINAL PUBLICATION IN 2019

4484
03:37:47,263 --> 03:37:49,098
BUT THERE IS AN EVOLUTION GOING

4485
03:37:49,098 --> 03:37:51,167
ON MORE AND MORE ADVERSE EVENTS

4486
03:37:51,167 --> 03:37:56,672
ARE BEING ADDED.

4487
03:37:56,672 --> 03:37:57,673
WITH THE STRUCTURE OF

4488
03:37:57,673 --> 03:38:01,577
REPORTING.

4489
03:38:01,577 --> 03:38:08,250
AND MEASURING EFFICACIES SO WITH

4490
03:38:08,250 --> 03:38:08,818
THE CHARACTERISTICS OF THE

4491
03:38:08,818 --> 03:38:09,785
POPULATION THERE IS LOTS OF

4492
03:38:09,785 --> 03:38:15,357
VARIABILITY AND THAT IS

4493
03:38:15,357 --> 03:38:25,901
DEVELOPING BETTER CARE AND WHEN

4494
03:38:27,903 --> 03:38:28,471
YOU HAVE TO ACCOUNT FOR SOME OF

4495
03:38:28,471 --> 03:38:29,071
THOSE CHANGES IN DOING STUDIES

4496
03:38:29,071 --> 03:38:29,672
AND DOING ANALYSIS AND CHANGES

4497
03:38:29,672 --> 03:38:30,206
OF REFERENCE AND HOW DO WE

4498
03:38:30,206 --> 03:38:30,806
MEASURE A MEANINGFUL CLINICAL

4499
03:38:30,806 --> 03:38:31,040
BENEFIT?

4500
03:38:31,040 --> 03:38:34,477
AND IT FEELS FUNCTIONS AND THEN

4501
03:38:34,477 --> 03:38:40,216
NEONATAL POPULATION WE DO HAVE

4502
03:38:40,216 --> 03:38:40,783
SOME OPPORTUNITIES TO ASSESS

4503
03:38:40,783 --> 03:38:42,585
FUNCTION AND SURVIVAL AND THEN

4504
03:38:42,585 --> 03:38:44,987
MORTALITY AND MORBIDITY OUTCOMES

4505
03:38:44,987 --> 03:38:51,727
ARE FREQUENTLY LOOKED AT BUT

4506
03:38:51,727 --> 03:38:52,361
HOPEFULLY THAT IS OVER A PERIOD

4507
03:38:52,361 --> 03:38:52,962
OF TIME SO 1 OF THE THINGS WE

4508
03:38:52,962 --> 03:38:57,233
CAN DO AND THINKING ABOUT IT

4509
03:38:57,233 --> 03:38:57,833
CLINICIANS AND FAMILY MEMBERS

4510
03:38:57,833 --> 03:39:02,838
AND OTHER STAKEHOLDERS THAT ARE

4511
03:39:02,838 --> 03:39:05,708
CLINICALLY RELEVANT.

4512
03:39:05,708 --> 03:39:12,214
LOOKING AT COMPOSITE OUTCOMES.

4513
03:39:12,214 --> 03:39:13,616
AND THEN TO ADDRESS THE

4514
03:39:13,616 --> 03:39:21,490
OUTCOMES.

4515
03:39:21,490 --> 03:39:22,091
AND LOOKING AT THE NET BENEFIT

4516
03:39:22,091 --> 03:39:22,992
OF THERAPY AND ANOTHER BENEFIT

4517
03:39:22,992 --> 03:39:32,201
STATISTICALLY ESPECIALLY WITH

4518
03:39:32,201 --> 03:39:32,735
MISSING DATA OR INDIVIDUAL

4519
03:39:32,735 --> 03:39:38,707
COMPONENTS SO IF YOU EQUALLY

4520
03:39:38,707 --> 03:39:43,212
WAGE THE COMPONENTS BUT THE

4521
03:39:43,212 --> 03:39:46,682
EQUAL WEIGHTING YOU NEED TO

4522
03:39:46,682 --> 03:39:57,059
CONSIDER THAT AS WELL.

4523
03:39:57,059 --> 03:39:58,160
AND THEN THOSE ARE MUCH MORE

4524
03:39:58,160 --> 03:40:02,898
CHALLENGING.

4525
03:40:02,898 --> 03:40:05,568
WHAT CAN WE DO TO OPTIMIZE

4526
03:40:05,568 --> 03:40:07,736
EFFICIENCY?

4527
03:40:07,736 --> 03:40:14,543
THIS IS GETTING US AWAY AND THEN

4528
03:40:14,543 --> 03:40:18,213
HOW WE CAN DESIGN TRIALS TO

4529
03:40:18,213 --> 03:40:18,714
PRESENT WITH MEANINGFUL

4530
03:40:18,714 --> 03:40:18,981
BENEFITS.

4531
03:40:18,981 --> 03:40:22,851
CAN WE ADOPT MONSTER PROTOCOLS

4532
03:40:22,851 --> 03:40:31,694
TO REINVENT THE WHEEL TO ADAPT

4533
03:40:31,694 --> 03:40:32,895
PROTOCOLS THAT HAVE BEEN

4534
03:40:32,895 --> 03:40:33,162
RELEASED.

4535
03:40:33,162 --> 03:40:36,966
CENTRALIZING IRB A NUMBER OF

4536
03:40:36,966 --> 03:40:37,766
LOCATIONS AND ACTUALLY FEDERAL

4537
03:40:37,766 --> 03:40:44,206
RESPONSIVE STUDIES AND THEN

4538
03:40:44,206 --> 03:40:46,575
USING REAL-WORLD DATA TO

4539
03:40:46,575 --> 03:40:49,678
GENERATE REAL-WORLD EVIDENCE.

4540
03:40:49,678 --> 03:40:55,150
SOME TRIAL DESIGN STRATEGIES

4541
03:40:55,150 --> 03:41:01,056
THAT ARE NOT NEW ANY MORE

4542
03:41:01,056 --> 03:41:01,690
SOMETHING THAT HAS BEEN LOOKED

4543
03:41:01,690 --> 03:41:03,726
AT VERY CLOSELY BUT THAT IS THE

4544
03:41:03,726 --> 03:41:14,269
APPROACH OF PRIOR PROBABILITIES

4545
03:41:14,637 --> 03:41:15,170
THAT THE EVENT WILL OCCUR AND

4546
03:41:15,170 --> 03:41:15,638
THE ADVANTAGE OF USING

4547
03:41:15,638 --> 03:41:16,271
STATISTICS THAT YOU CAN FORMALLY

4548
03:41:16,271 --> 03:41:16,872
INCORPORATE RESULTS THAT HAVE

4549
03:41:16,872 --> 03:41:17,473
BEEN DONE ON OTHER STUDIES AND

4550
03:41:17,473 --> 03:41:21,043
YOU CAN ACTUALLY UPDATE AS THE

4551
03:41:21,043 --> 03:41:24,146
EVIDENCE ACCRUES AND THAT HELPS

4552
03:41:24,146 --> 03:41:25,514
YOU WITH THE WEIGHTS OF BENEFITS

4553
03:41:25,514 --> 03:41:29,518
AND HARMS THAT IS WHAT WE

4554
03:41:29,518 --> 03:41:32,388
TRADITIONALLY THINK ABOUT AND 1

4555
03:41:32,388 --> 03:41:40,562
OF THE CHALLENGES WITH THIS

4556
03:41:40,562 --> 03:41:41,096
APPROACH AND THERE IS SOME

4557
03:41:41,096 --> 03:41:41,697
ARBITRARY THRESHOLDS THAT HAVE

4558
03:41:41,697 --> 03:41:45,234
TO BE DECIDED UPON AT THE

4559
03:41:45,234 --> 03:41:47,036
TRIAL.

4560
03:41:47,036 --> 03:41:53,642
I CANNOT EMPHASIZE THIS ENOUGH.

4561
03:41:53,642 --> 03:41:57,346
TO ENGAGE STAKEHOLDERS AND

4562
03:41:57,346 --> 03:41:58,681
PARENTS AND CAREGIVERS AND

4563
03:41:58,681 --> 03:42:01,483
ADVOCACY GROUPS ARE CRITICAL

4564
03:42:01,483 --> 03:42:05,587
THIS IS SOMETHING WE WANT TO DO

4565
03:42:05,587 --> 03:42:07,056
AT THE TIME TO THINK ABOUT

4566
03:42:07,056 --> 03:42:14,430
ENGAGING NURSES OR PSYCHOLOGISTS

4567
03:42:14,430 --> 03:42:15,064
IT COURSE THE REGULATORY FUNDING

4568
03:42:15,064 --> 03:42:15,531
AGENCIES AND INDUSTRY

4569
03:42:15,531 --> 03:42:16,031
PARTNERSHIPS WHICH IS SO

4570
03:42:16,031 --> 03:42:18,934
CRITICAL.

4571
03:42:18,934 --> 03:42:19,501
WAS STATISTICIANS NEED TO BE

4572
03:42:19,501 --> 03:42:24,673
INVOLVED FROM THE BEGINNING AND

4573
03:42:24,673 --> 03:42:29,812
INCLUDING THE MAD ASSIST WITH A

4574
03:42:29,812 --> 03:42:30,579
TREMENDOUS AMOUNT OF DATA TO PUT

4575
03:42:30,579 --> 03:42:33,882
TOGETHER IN SOME MEANINGFUL WAY

4576
03:42:33,882 --> 03:42:34,583
WHETHER THE USE OF ARTIFICIAL

4577
03:42:34,583 --> 03:42:35,851
INTELLIGENCE OR OTHER MACHINE

4578
03:42:35,851 --> 03:42:42,991
LEARNING REALLY INVOLVING TO BE

4579
03:42:42,991 --> 03:42:43,358
VERY BENEFICIAL.

4580
03:42:43,358 --> 03:42:43,992
ALL OF THIS ENGAGEMENT HELPS TO

4581
03:42:43,992 --> 03:42:50,599
INFORM TRIAL DESIGN WITH

4582
03:42:50,599 --> 03:42:51,133
MEANINGFUL AND POINTS WITH

4583
03:42:51,133 --> 03:42:51,734
ENGAGEMENT IN RECRUITMENT AND

4584
03:42:51,734 --> 03:42:53,235
THEN ALSO HOPEFULLY WILL HELP US

4585
03:42:53,235 --> 03:42:55,104
PREDICT BARRIERS TO OVERCOME IN

4586
03:42:55,104 --> 03:43:03,512
ADVANCE OF IMPLEMENTING THE

4587
03:43:03,512 --> 03:43:03,946
TRIAL AND RESOURCES.

4588
03:43:03,946 --> 03:43:05,180
>> I JUST WANT TO
HIGHLIGHT THE

4589
03:43:05,180 --> 03:43:06,682
INTERVENTION WHICH I THINK IS

4590
03:43:06,682 --> 03:43:14,256
INTERESTING.

4591
03:43:14,256 --> 03:43:15,290
AND THIS WAS AN INTERVENTION

4592
03:43:15,290 --> 03:43:20,129
MAPPING.

4593
03:43:20,129 --> 03:43:21,430
BUT THE SYSTEMATIC PROCESS TO

4594
03:43:21,430 --> 03:43:30,572
LOOK AT A PROTOCOL AND THEN THE

4595
03:43:30,572 --> 03:43:31,106
KEY POINT ABOUT THIS BRIEF

4596
03:43:31,106 --> 03:43:35,511
INTERVENTION WITH RESEARCH TEAM

4597
03:43:35,511 --> 03:43:37,746
MEMBERS TO GET FEEDBACK AND THE

4598
03:43:37,746 --> 03:43:39,882
APPROACH INCLUDING FEEDBACK FROM

4599
03:43:39,882 --> 03:43:44,186
FAMILY MEMBERS ABOUT THE UTILITY

4600
03:43:44,186 --> 03:43:47,723
OF VARIOUS COMPONENTS TO BE

4601
03:43:47,723 --> 03:43:58,400
PERCEIVED AND OPTIMIZE AND IT IS

4602
03:43:58,400 --> 03:43:58,967
OUTSIDE OF THE REALM OF WHAT WE

4603
03:43:58,967 --> 03:44:02,337
TRADITIONALLY THINK ABOUT AND

4604
03:44:02,337 --> 03:44:05,440
THAT CAN BE REALLY HELPFUL

4605
03:44:05,440 --> 03:44:07,042
ESPECIALLY IF THERE ARE

4606
03:44:07,042 --> 03:44:13,482
CHALLENGES IN THE MOMENT.

4607
03:44:13,482 --> 03:44:17,519
TAKE ADVANTAGE AND LEVERAGING

4608
03:44:17,519 --> 03:44:26,628
THE NEONATAL NETWORKS AND THERE

4609
03:44:26,628 --> 03:44:33,135
ARE MANY MORE AND AND THEN

4610
03:44:33,135 --> 03:44:35,470
ACROSS THE GLOBAL BORDERS AND

4611
03:44:35,470 --> 03:44:39,074
SOME OF THESE GROUPS IN THE

4612
03:44:39,074 --> 03:44:41,743
RESEARCH NETWORKS COULD BE

4613
03:44:41,743 --> 03:44:45,981
EXTREMELY BENEFICIAL HOPING TO

4614
03:44:45,981 --> 03:44:46,949
WORK THROUGH INFRASTRUCTURE

4615
03:44:46,949 --> 03:44:57,092
ISSUES.

4616
03:44:58,694 --> 03:44:59,194
AND WITH THOSE CHALLENGES OF

4617
03:44:59,194 --> 03:44:59,795
CLINICAL DESIGN THERE IS A LOT

4618
03:44:59,795 --> 03:45:03,432
OF VARIABILITY AND REPORTING OF

4619
03:45:03,432 --> 03:45:07,536
OUTCOMES AND THEN DESCRIBE THAT

4620
03:45:07,536 --> 03:45:12,841
WITH THAT META-ANALYSIS WITH A

4621
03:45:12,841 --> 03:45:13,375
HAS BEEN DEVELOPED IS THE

4622
03:45:13,375 --> 03:45:17,279
NEONATAL OUTCOMES THAT AND

4623
03:45:17,279 --> 03:45:18,580
BASICALLY THIS IS A SET OF

4624
03:45:18,580 --> 03:45:23,118
OUTCOMES AGREED-UPON FOR OTHER

4625
03:45:23,118 --> 03:45:26,622
INDIVIDUALS CLINICALLY IMPORTANT

4626
03:45:26,622 --> 03:45:27,256
THAT SHOULD BE ASSESSED AND THEN

4627
03:45:27,256 --> 03:45:29,691
NEONATAL TRIALS.

4628
03:45:29,691 --> 03:45:31,260
IN THE SEPTEMBER EDITION OF

4629
03:45:31,260 --> 03:45:35,230
PEDIATRICS THAT RELATE TO THE

4630
03:45:35,230 --> 03:45:38,967
NEONATAL OUTCOME AND HOW THEY

4631
03:45:38,967 --> 03:45:41,203
CAN BE USED AND 1 OF THE

4632
03:45:41,203 --> 03:45:42,971
MANUSCRIPTS TOOK 36 NEONATAL

4633
03:45:42,971 --> 03:45:47,643
TRIALS OR THE 100 PARTICIPANTS

4634
03:45:47,643 --> 03:45:49,478
FROM 2015 THROUGH 2020 AND THEY

4635
03:45:49,478 --> 03:45:58,220
APPLIED THE CONSORT OF THE

4636
03:45:58,220 --> 03:45:58,854
OUTCOMES AND GUIDANCE TO EACH 1

4637
03:45:58,854 --> 03:45:59,421
OF THE TRIALS AND SUBDIVIDED

4638
03:45:59,421 --> 03:45:59,988
THEM INTO DIFFERENT OUTCOME

4639
03:45:59,988 --> 03:46:02,824
CATEGORIES SHORT-TERM NEONATAL

4640
03:46:02,824 --> 03:46:10,933
COMPLICATIONS AND THEN WHAT THE

4641
03:46:10,933 --> 03:46:12,367
MANUSCRIPT DOES IS EMPHASIZE

4642
03:46:12,367 --> 03:46:14,836
WHICH STUDIES HAVE DONE THIS AND

4643
03:46:14,836 --> 03:46:17,973
HOW THEY MANAGE SO ONCE AGAIN

4644
03:46:17,973 --> 03:46:18,540
THIS IS ANOTHER TOOL IN THE

4645
03:46:18,540 --> 03:46:21,143
TOOLBOX WE CAN USE TO HELP

4646
03:46:21,143 --> 03:46:29,818
STANDARDIZED OUTCOMES.

4647
03:46:29,818 --> 03:46:34,589
AND WITH THOSE TRIALS THERE ARE

4648
03:46:34,589 --> 03:46:39,428
MANY CHALLENGES SO JUST IN

4649
03:46:39,428 --> 03:46:42,998
GENERAL WITH HUMAN CLINICAL

4650
03:46:42,998 --> 03:46:44,967
TRIALS AND TO TALK ABOUT THE

4651
03:46:44,967 --> 03:46:48,503
DIFFERENT COMPARISON GROUPS THE

4652
03:46:48,503 --> 03:46:53,108
SAMPLE SIZE DIFFERENCES AND SOME

4653
03:46:53,108 --> 03:46:55,978
OF THIS HAS PROGRESSED OVER THE

4654
03:46:55,978 --> 03:47:01,083
LAST DECADE AND THOSE THAT

4655
03:47:01,083 --> 03:47:05,887
REMAIN AND WHAT IS NEEDED AND

4656
03:47:05,887 --> 03:47:09,958
WHEN DO WE NEED TO STRATIFY?

4657
03:47:09,958 --> 03:47:10,592
IT IS IMPORTANT TO DO THAT IF WE

4658
03:47:10,592 --> 03:47:16,832
HAVE DIFFERENCE JUST TO GO

4659
03:47:16,832 --> 03:47:17,332
BETWEEN THE 2 GROUPS AT

4660
03:47:17,332 --> 03:47:17,666
BASELINE.

4661
03:47:17,666 --> 03:47:26,708
ENDPOINT SELECTION.

4662
03:47:26,708 --> 03:47:27,376
WE REFER TO THAT CAN WE USE THE

4663
03:47:27,376 --> 03:47:27,976
ENDPOINT ON THE GOOD ONES WITH

4664
03:47:27,976 --> 03:47:29,511
GOOD PREDICTIVE VALUE AND HOW DO

4665
03:47:29,511 --> 03:47:32,681
THEY REMAIN IN THINKING THROUGH

4666
03:47:32,681 --> 03:47:38,820
THAT CAN USE AS AN EARLY

4667
03:47:38,820 --> 03:47:39,454
INDICATOR OF DYSFUNCTION AND IF

4668
03:47:39,454 --> 03:47:41,623
YOU DO USE LABORATORY FOR WHAT

4669
03:47:41,623 --> 03:47:42,591
IS NORMAL AND WHAT IS THE

4670
03:47:42,591 --> 03:47:48,563
REFERENCE.

4671
03:47:48,563 --> 03:47:50,165
FOR THE CHALLENGES AND BENEFITS

4672
03:47:50,165 --> 03:47:55,003
AS WELL.

4673
03:47:55,003 --> 03:47:56,371
SO THE OTHER POINT I ALSO WANT

4674
03:47:56,371 --> 03:47:59,074
TO EMPHASIZE THAT WE TALKED

4675
03:47:59,074 --> 03:48:02,110
ABOUT IS STANDARDIZATION OF

4676
03:48:02,110 --> 03:48:06,681
INTERVENTION WITH LBP AND IT IS

4677
03:48:06,681 --> 03:48:11,019
SPECIFIC OF THE STRAIN THAT HAS

4678
03:48:11,019 --> 03:48:12,220
BEEN USED IN DESCRIBING THE

4679
03:48:12,220 --> 03:48:16,992
NOMENCLATURE SO EVERYONE IS

4680
03:48:16,992 --> 03:48:19,428
AWARE OF THE PRODUCT THAT HAS

4681
03:48:19,428 --> 03:48:26,835
BEEN USED AND THEN THE SCHEMATIC

4682
03:48:26,835 --> 03:48:27,469
THAT WAS PUBLISHED QUITE A WHILE

4683
03:48:27,469 --> 03:48:31,039
AGO BUT RANGES TRUE TODAY THAT I

4684
03:48:31,039 --> 03:48:32,908
THINKING ABOUT THE PRODUCT WHAT

4685
03:48:32,908 --> 03:48:34,009
IS HAPPENING TO THE PRODUCT AS

4686
03:48:34,009 --> 03:48:38,313
IT GOES TO THE HOST AS IT IS

4687
03:48:38,313 --> 03:48:40,749
STORED AND ADMINISTERED AND EVEN

4688
03:48:40,749 --> 03:48:41,817
GOING BACK TO ACTUAL

4689
03:48:41,817 --> 03:48:49,357
PRODUCTION.

4690
03:48:49,357 --> 03:48:49,958
THESE ARE ALL KEY ISSUES THAT

4691
03:48:49,958 --> 03:48:50,926
NEED TO BE SPECIFIED

4692
03:48:50,926 --> 03:48:54,496
SPECIFICALLY WHEN CONDUCTING A

4693
03:48:54,496 --> 03:48:55,497
TRIAL SO THERE IS AN

4694
03:48:55,497 --> 03:49:01,069
UNDERSTANDING.

4695
03:49:01,069 --> 03:49:01,670
AND THEN ADHERENCE WHICH IS

4696
03:49:01,670 --> 03:49:06,908
ALWAYS A CHALLENGE.

4697
03:49:06,908 --> 03:49:14,483
SO WITH NEONATES THAT MAY NOT

4698
03:49:14,483 --> 03:49:17,752
ALWAYS BE POSSIBLE SO IS THERE A

4699
03:49:17,752 --> 03:49:23,291
WAY OR OTHER WAYS TO MIMIC

4700
03:49:23,291 --> 03:49:23,725
DIRECTLY IN THE NON-

4701
03:49:23,725 --> 03:49:24,359
HOSPITALIZED INDIVIDUAL AND THE

4702
03:49:24,359 --> 03:49:28,463
STOOL ASSESSMENTS ELECTRONIC

4703
03:49:28,463 --> 03:49:32,467
MONITORING AND THEN THE VALUE OF

4704
03:49:32,467 --> 03:49:35,036
SELF-MONITORING AS WELL ARE WAYS

4705
03:49:35,036 --> 03:49:38,640
WE CAN ASSESS ADHERENCE AND SO

4706
03:49:38,640 --> 03:49:43,979
THEN WE GET A COMPOSITE IDEA OF

4707
03:49:43,979 --> 03:49:44,379
WHAT ADHERENCE IS.

4708
03:49:44,379 --> 03:49:54,789
SAFETY ASSESSMENT REALLY

4709
03:49:56,491 --> 03:49:57,058
REPORTING IN A STANDARDIZED WAY

4710
03:49:57,058 --> 03:49:57,692
TO PRE- SPECIFY WHAT SEVERITY IS

4711
03:49:57,692 --> 03:49:58,326
WITHOUT ASSOCIATION MANY STUDIES

4712
03:49:58,326 --> 03:49:59,027
UNFORTUNATELY SAY NO SAFETY

4713
03:49:59,027 --> 03:50:00,729
EVENTS WERE OBSERVED IN THAT CAN

4714
03:50:00,729 --> 03:50:03,865
BE VERY CHALLENGING BECAUSE HOW

4715
03:50:03,865 --> 03:50:06,301
YOU DEFINE THE SAFETY EVENT AND

4716
03:50:06,301 --> 03:50:11,006
WHAT IS THE OBSERVATION?

4717
03:50:11,006 --> 03:50:11,573
SO TO BE VERY INTENTIONAL OF

4718
03:50:11,573 --> 03:50:12,007
SAFETY ASSESSMENTS.

4719
03:50:12,007 --> 03:50:19,214
1 OF THE APPLICATION THAT I

4720
03:50:19,214 --> 03:50:20,448
DESCRIBED WHEN WE ARE THINKING

4721
03:50:20,448 --> 03:50:29,791
ABOUT SAFETY EVENTS FOR LBP.

4722
03:50:29,791 --> 03:50:30,392
AND FINALLY I JUST WANT TO AND

4723
03:50:30,392 --> 03:50:30,926
WITH SOME OPPORTUNITIES I

4724
03:50:30,926 --> 03:50:35,497
PRESENTED A LOT OF CHALLENGES.

4725
03:50:35,497 --> 03:50:38,133
ALTHOUGH THERE ARE TOOLS IN THE

4726
03:50:38,133 --> 03:50:40,769
TOOLBOX SO THINKING PROACTIVELY

4727
03:50:40,769 --> 03:50:41,970
WHEN WE ARE DESIGNING TRIALS TO

4728
03:50:41,970 --> 03:50:44,573
BE VERY INTENTIONAL.

4729
03:50:44,573 --> 03:50:47,142
THINKING OF HOW WE CAN BE

4730
03:50:47,142 --> 03:50:50,345
ADAPTIVE AS WE DESIGN STUDIES

4731
03:50:50,345 --> 03:50:52,914
AND HOW WE CAN HAVE A RIGOROUS

4732
03:50:52,914 --> 03:50:55,750
STUDY WITH REAL-WORLD

4733
03:50:55,750 --> 03:50:59,688
APPLICATIONS AND I CANNOT

4734
03:50:59,688 --> 03:51:03,491
EMPHASIZE THE IMPORTANCE OF THAT

4735
03:51:03,491 --> 03:51:09,197
AND I HAVE COME TO VALUE THE

4736
03:51:09,197 --> 03:51:09,664
GUIDANCE FROM NOT ONLY

4737
03:51:09,664 --> 03:51:13,134
PARTICIPANTS AND FAMILY MEMBERS

4738
03:51:13,134 --> 03:51:14,169
AS WELL AS THINKING ABOUT

4739
03:51:14,169 --> 03:51:17,906
LONGER-TERM OUTCOMES THINKING

4740
03:51:17,906 --> 03:51:19,140
ABOUT BEHAVIORAL PSYCHOLOGY AND

4741
03:51:19,140 --> 03:51:21,643
SOCIAL WORKERS TO BE ENGAGED IN

4742
03:51:21,643 --> 03:51:27,115
MANY STUDIES AND THAT IS AN

4743
03:51:27,115 --> 03:51:28,083
EXAMPLE VERY WELL OF ENGAGING

4744
03:51:28,083 --> 03:51:38,326
THE COMMUNITY.

4745
03:51:42,130 --> 03:51:42,631
AND EFFICIENTLY AS POSSIBLE

4746
03:51:42,631 --> 03:51:43,131
RELATED TO OPERATIONS TO

4747
03:51:43,131 --> 03:51:43,632
OPTIMIZE OUR SCIENTIFIC

4748
03:51:43,632 --> 03:51:43,898
DISCOVERY.

4749
03:51:43,898 --> 03:51:44,532
UNFORTUNATELY WE ARE CHALLENGED

4750
03:51:44,532 --> 03:51:47,002
BY THE OPERATIONAL LIMITATION.

4751
03:51:47,002 --> 03:51:47,569
IF WE CAN GET BEYOND THAT TO

4752
03:51:47,569 --> 03:51:48,136
THINK ABOUT FOCUSING ON THE

4753
03:51:48,136 --> 03:51:52,307
SCIENTIFIC DISCOVERY THAT WOULD

4754
03:51:52,307 --> 03:51:53,275
HELP WITH THE COLLECTION AND THE

4755
03:51:53,275 --> 03:51:54,309
ANALYSIS.

4756
03:51:54,309 --> 03:51:58,580
AND THEN FINALLY WITH PRODUCT

4757
03:51:58,580 --> 03:52:01,549
DEFINITIONS AND COMPOSITIONS AND

4758
03:52:01,549 --> 03:52:07,656
REGULATORY GUIDANCE.

4759
03:52:07,656 --> 03:52:09,424
THANK YOU VERY MUCH FOR YOUR

4760
03:52:09,424 --> 03:52:09,724
ENGAGEMENT.

4761
03:52:09,724 --> 03:52:19,901
[APPLAUSE]

4762
03:52:24,572 --> 03:52:31,046
>> WE HAVE 15 MINUTES FOR
Q&A

4763
03:52:31,046 --> 03:52:31,713
AND PLENTY OF TIME TO UNPACK

4764
03:52:31,713 --> 03:52:36,651
WHAT WAS SAID ALWAYS TO

4765
03:52:36,651 --> 03:52:38,787
ENCOURAGE THE ONLINE

4766
03:52:38,787 --> 03:52:39,421
PARTICIPANTS WITH THE QUESTIONS

4767
03:52:39,421 --> 03:52:49,631
IN THE CHAT.

4768
03:52:57,038 --> 03:53:01,710
>> FOR DOCTOR WARNER THANK
YOU

4769
03:53:01,710 --> 03:53:02,243
FOR YOUR PRESENTATION VERY

4770
03:53:02,243 --> 03:53:02,544
INTERESTING.

4771
03:53:02,544 --> 03:53:08,683
I WAS WONDERING ISN'T BREASTMILK

4772
03:53:08,683 --> 03:53:09,284
A PROBIOTIC AND ITSELF AND HOW

4773
03:53:09,284 --> 03:53:12,587
DOES THAT COMPARE TO YOUR MICRO

4774
03:53:12,587 --> 03:53:17,225
COMMUNITIES AND WHERE THOSE KIDS

4775
03:53:17,225 --> 03:53:17,659
BREAST-FED ARE NOT?

4776
03:53:17,659 --> 03:53:19,427
AS WE ARE HEARING THAT SEEMS TO

4777
03:53:19,427 --> 03:53:20,829
HAVE SOME EFFECTIVENESS OF

4778
03:53:20,829 --> 03:53:25,800
TREATING NEC.

4779
03:53:25,800 --> 03:53:27,035
>> BREASTMILK HAS ITS OWN

4780
03:53:27,035 --> 03:53:31,806
MICROBIAL COMMUNITY AND IT

4781
03:53:31,806 --> 03:53:34,542
INTERFACES WITH THE GOT

4782
03:53:34,542 --> 03:53:39,280
MICROBIAL COMPONENTS THAT

4783
03:53:39,280 --> 03:53:40,715
DEVELOPS THERE AS WELL SO BY

4784
03:53:40,715 --> 03:53:46,621
DEFINITION PERHAPS IT IS A

4785
03:53:46,621 --> 03:53:47,255
PROBIOTIC THAT IS INDIVIDUALIZED

4786
03:53:47,255 --> 03:53:50,425
FOR EACH BABY MOTHER NATURE IS

4787
03:53:50,425 --> 03:53:52,660
PRETTY SMART.

4788
03:53:52,660 --> 03:53:56,364
BUT THE QUESTION PERHAPS IS HOW

4789
03:53:56,364 --> 03:53:59,300
DOES THAT INTERFACE SUBSEQUENT

4790
03:53:59,300 --> 03:54:09,677
EFFECTS THAT YOU SEE?

4791
03:54:09,878 --> 03:54:10,278
THAT IS THE QUESTION.

4792
03:54:10,278 --> 03:54:10,712
IT DEFINITELY DOES.

4793
03:54:10,712 --> 03:54:11,279
WE ARE JUST STARTING TO PAY

4794
03:54:11,279 --> 03:54:11,679
ATTENTION TO THAT.

4795
03:54:11,679 --> 03:54:21,089
AND I DO WONDER WHY ARE WE

4796
03:54:21,089 --> 03:54:21,656
SEEING SUCH AN EFFECT UNDER

4797
03:54:21,656 --> 03:54:21,956
1000 GRAMS?

4798
03:54:21,956 --> 03:54:22,557
IS IT BECAUSE OF THE MICROBIAL

4799
03:54:22,557 --> 03:54:27,061
COMMUNITY THAT IS PRESENT IN ANY

4800
03:54:27,061 --> 03:54:29,597
1 PARTICULAR MICROBE OR HOW THAT

4801
03:54:29,597 --> 03:54:33,935
WORKS SO THE MATERNAL ACT WILL

4802
03:54:33,935 --> 03:54:35,103
IMPACT THE OUTCOMES OF THE

4803
03:54:35,103 --> 03:54:38,072
STUDY.

4804
03:54:38,072 --> 03:54:46,815
>> THINKING ABOUT IT AS A

4805
03:54:46,815 --> 03:54:52,220
PRODUCT OR A DRUG WOULD IT BE

4806
03:54:52,220 --> 03:54:54,789
SOMETHING YOU WOULD WANT TO KNOW

4807
03:54:54,789 --> 03:54:56,991
MORE ABOUT?

4808
03:54:56,991 --> 03:54:59,561
TAKING THAT AS PART OF THE

4809
03:54:59,561 --> 03:55:04,065
TRIAL?

4810
03:55:04,065 --> 03:55:05,166
>> WE KNOW THAT MICROBE

4811
03:55:05,166 --> 03:55:07,802
INTERACTIONS AND THOSE

4812
03:55:07,802 --> 03:55:08,436
COMMUNITIES DO NOT ALWAYS PLAY

4813
03:55:08,436 --> 03:55:14,142
WELL TOGETHER IN THE SANDBOX

4814
03:55:14,142 --> 03:55:14,809
WITH THOSE DRUG INTERACTIONS IN

4815
03:55:14,809 --> 03:55:15,076
A TRIAL.

4816
03:55:15,076 --> 03:55:21,015
>> ABSOLUTELY I WOULD GO
BACK TO

4817
03:55:21,015 --> 03:55:21,649
SOME OF THE CHALLENGES OF DOING

4818
03:55:21,649 --> 03:55:22,150
THE STUDIES IN THE NICU.

4819
03:55:22,150 --> 03:55:31,860
PARTICULARLY EARLY ON.

4820
03:55:31,860 --> 03:55:32,560
YOU WANT TO CAPTURE EVERY SINGLE

4821
03:55:32,560 --> 03:55:33,027
THING AND PULL THAT UP

4822
03:55:33,027 --> 03:55:35,396
AT.1 MICROLITERS CC TO GIVE ORAL

4823
03:55:35,396 --> 03:55:35,730
IMMUNOTHERAPY.

4824
03:55:35,730 --> 03:55:46,207
THAT'S 1 OF THE CHALLENGES.

4825
03:55:47,976 --> 03:55:48,543
I'M NOT A BIG BREASTMILK FAN BUT

4826
03:55:48,543 --> 03:55:49,143
THE CHALLENGE IS TO OBTAIN THE

4827
03:55:49,143 --> 03:55:49,544
PRODUCT OVER TIME.

4828
03:55:49,544 --> 03:55:50,178
IT CAN BE DONE FROM A PRAGMATIC

4829
03:55:50,178 --> 03:55:52,780
STANDPOINT AND ADDS TO THE COST

4830
03:55:52,780 --> 03:55:53,348
IT'S NOT NECESSARILY EASY TO

4831
03:55:53,348 --> 03:56:00,455
ANALYZE THE COMPONENTS.

4832
03:56:00,455 --> 03:56:01,022
THERE IS A LOT OF FAT IN IT

4833
03:56:01,022 --> 03:56:01,489
THOSE ARE CHALLENGES.

4834
03:56:01,489 --> 03:56:05,426
BUT I WOULD AGREE IDEALLY WITH

4835
03:56:05,426 --> 03:56:09,831
THEM A TABLEAU - - A TABLEAU X

4836
03:56:09,831 --> 03:56:10,798
STUDY 1 OF THE COMPONENTS TO

4837
03:56:10,798 --> 03:56:18,840
LOOK AT.

4838
03:56:18,840 --> 03:56:24,145
>> AS A FOLLOW-UP
QUESTION, IN

4839
03:56:24,145 --> 03:56:25,179
TERMS OF THE VARIATION OF THE

4840
03:56:25,179 --> 03:56:28,716
PROBIOTIC USED WHAT IS KNOWN

4841
03:56:28,716 --> 03:56:31,920
SPECIFICALLY QUANTITATIVELY OF

4842
03:56:31,920 --> 03:56:39,694
THE PRODUCT OVER TIME AND WITH

4843
03:56:39,694 --> 03:56:40,194
THAT CONSISTENCY IN THE

4844
03:56:40,194 --> 03:56:40,828
COMPOSITION AND STABILITY IN THE

4845
03:56:40,828 --> 03:56:44,165
STUDIES THAT YOU DESCRIBE.

4846
03:56:44,165 --> 03:56:45,266
>> CERTAINLY IN SOME OF
THE

4847
03:56:45,266 --> 03:56:47,569
EARLIER STUDIES UNFORTUNATELY IT

4848
03:56:47,569 --> 03:56:57,111
SHOWED VERY LITTLE PRODUCT FROM

4849
03:56:57,111 --> 03:56:58,212
WHAT WAS PRESENT I THINK THAT

4850
03:56:58,212 --> 03:56:58,813
HAS CHANGED AND IN PARTICULAR

4851
03:56:58,813 --> 03:56:59,380
SOME MANUFACTURERS THEY ARE

4852
03:56:59,380 --> 03:57:02,183
FAIRLY STRINGENT IN WHAT IS

4853
03:57:02,183 --> 03:57:10,058
PRODUCED.

4854
03:57:10,058 --> 03:57:10,692
I AM CERTAINLY NOT A PRODUCTION

4855
03:57:10,692 --> 03:57:11,192
SPECIALIST TO THINK THE

4856
03:57:11,192 --> 03:57:11,726
PHARMACEUTICALS WOULD KNOW

4857
03:57:11,726 --> 03:57:12,293
BETTER INFORMATION HOW THEY

4858
03:57:12,293 --> 03:57:16,197
APPROACH THAT BUT THERE IS THAT

4859
03:57:16,197 --> 03:57:18,499
VARIATION EVEN IN BETWEEN THE

4860
03:57:18,499 --> 03:57:20,501
PRODUCTS WITH THE SAME PRODUCT

4861
03:57:20,501 --> 03:57:21,135
OVER TIME I THINK WE ARE GETTING

4862
03:57:21,135 --> 03:57:25,573
BETTER BUT THAT'S MORE OF THE

4863
03:57:25,573 --> 03:57:26,074
CHALLENGES THAT WE FACE.

4864
03:57:26,074 --> 03:57:33,815
HOW DO YOU ACCOUNT FOR THAT?

4865
03:57:33,815 --> 03:57:34,983
>> SO WITH THE IDEA OF
BEING A

4866
03:57:34,983 --> 03:57:43,691
LIVING ORGANISM AND WHAT HAPPENS

4867
03:57:43,691 --> 03:57:44,325
TO THE PRODUCT AFTER IT IS GIVEN

4868
03:57:44,325 --> 03:57:44,926
AND HAS THE POTENTIAL TO CROSS

4869
03:57:44,926 --> 03:57:45,426
CONTAMINATE OR AT LEAST

4870
03:57:45,426 --> 03:57:48,529
INTERFACE WITH CONTROLS SO JUST

4871
03:57:48,529 --> 03:57:53,635
THINKING ABOUT HOW THIS HAS

4872
03:57:53,635 --> 03:58:04,112
TAKEN AS WELL AS VERIFYING.

4873
03:58:05,046 --> 03:58:09,784
>> A LARGE TRIAL AFTER
BEING

4874
03:58:09,784 --> 03:58:14,055
ADMINISTERED BY THE STATE WE

4875
03:58:14,055 --> 03:58:17,525
TEST EVERY 6 MONTHS THE THIRD

4876
03:58:17,525 --> 03:58:21,362
BATCH WE EFFECTIVELY HAD IT

4877
03:58:21,362 --> 03:58:26,034
ANALYZED 2 WAYS AT THE OUTCOME

4878
03:58:26,034 --> 03:58:33,808
AND BETWEEN THEM COUNTRYWIDE OR

4879
03:58:33,808 --> 03:58:34,442
THEY DIDN'T UNFORTUNATELY IT DID

4880
03:58:34,442 --> 03:58:35,043
NOT MAKE A DIFFERENCE BUT YOU

4881
03:58:35,043 --> 03:58:37,578
HAVE TO HAVE GOOD MICROBES IN

4882
03:58:37,578 --> 03:58:41,416
MOST INTERVENTIONS YOU AUTHORIZE

4883
03:58:41,416 --> 03:58:42,784
DO NOT REPLICATE OR STOP

4884
03:58:42,784 --> 03:58:47,055
REPLICATING.

4885
03:58:47,055 --> 03:58:51,359
>> MAYBE THAT'S WHERE WE
GET

4886
03:58:51,359 --> 03:58:54,562
HELP FROM GOVERNMENT

4887
03:58:54,562 --> 03:59:03,271
COLLEAGUES.

4888
03:59:03,271 --> 03:59:03,604
>> THANK YOU.

4889
03:59:03,604 --> 03:59:05,006
INFORMATION ABOUT THE TRIALS AND

4890
03:59:05,006 --> 03:59:07,675
IDEALS IS TERRIFIC.

4891
03:59:07,675 --> 03:59:15,516
BUT HOW DO WE GET THERE?

4892
03:59:15,516 --> 03:59:16,117
DOES IT TAKE INVESTIGATORS OR

4893
03:59:16,117 --> 03:59:16,751
COMPANIES TO PROPOSE THESE NEXT

4894
03:59:16,751 --> 03:59:23,758
STEPS OR IS IT SOMETHING YOU

4895
03:59:23,758 --> 03:59:24,358
HAVE TO ASK THE CDC TO SAY WE

4896
03:59:24,358 --> 03:59:24,992
NEED A BETTER TRIAL IN THIS AREA

4897
03:59:24,992 --> 03:59:35,136
WITH MULTIPLE FOLKS INVOLVED?

4898
03:59:35,136 --> 03:59:35,703
>> THAT'S A GREAT
QUESTION.

4899
03:59:35,703 --> 03:59:36,337
1 OF THE THINGS IS

4900
03:59:36,337 --> 03:59:41,209
COLLABORATION.

4901
03:59:41,209 --> 03:59:41,809
THAT IS IMPORTANT ALSO DEPENDS

4902
03:59:41,809 --> 03:59:43,911
ON WHAT WE WILL USE THE TRIAL TO

4903
03:59:43,911 --> 03:59:53,788
DETERMINE IF IT'S THE APPROVAL

4904
03:59:53,788 --> 03:59:54,388
OF A PRODUCT THEN YOU NEED TO

4905
03:59:54,388 --> 03:59:54,989
INVOLVE REGULATORY INDUSTRY AS

4906
03:59:54,989 --> 03:59:55,456
WELL BUT THEN THINKING

4907
03:59:55,456 --> 03:59:56,090
CREATIVELY WHAT WE CAN CONSIDER

4908
03:59:56,090 --> 03:59:58,392
AS APPROPRIATE EVIDENCE.

4909
03:59:58,392 --> 04:00:00,661
AND TRIALS ARE 1 EXAMPLE BUT

4910
04:00:00,661 --> 04:00:06,300
THANKFULLY NOW THERE ARE SOME

4911
04:00:06,300 --> 04:00:06,934
IMPORTANT INFORMATION ON THE FDA

4912
04:00:06,934 --> 04:00:09,771
WEBSITE HOW TO USE THE STUDIES

4913
04:00:09,771 --> 04:00:12,240
AND SET THEM UP FOR VARIOUS

4914
04:00:12,240 --> 04:00:13,608
PRODUCTS.

4915
04:00:13,608 --> 04:00:14,876
ONCE AGAIN IT IS COMMUNICATION

4916
04:00:14,876 --> 04:00:21,215
AND CORROBORATION SO I THINK 1

4917
04:00:21,215 --> 04:00:22,717
OF THE CHALLENGES IS IT SEEMS

4918
04:00:22,717 --> 04:00:25,186
OVERWHELMING YOU AS AN

4919
04:00:25,186 --> 04:00:26,087
INVESTIGATOR ARE TRYING TO START

4920
04:00:26,087 --> 04:00:36,531
SOMETHING NEW AND FOR THE

4921
04:00:39,300 --> 04:00:39,834
NETWORK AS AN EXAMPLE FINDING

4922
04:00:39,834 --> 04:00:40,434
OUT WHAT HAS ALREADY BEEN DONE

4923
04:00:40,434 --> 04:00:41,068
AND SOME OF THE OTHER NETWORKS I

4924
04:00:41,068 --> 04:00:41,536
LISTED AS WELL OR THE

4925
04:00:41,536 --> 04:00:42,570
OPPORTUNITY TO WORK TOGETHER AND

4926
04:00:42,570 --> 04:00:45,139
COLLABORATE.

4927
04:00:45,139 --> 04:00:54,982
>> AS A -- -- I WAS
THINKING AS

4928
04:00:54,982 --> 04:00:55,616
YOU WERE SPEAKING THAT JOURNALS

4929
04:00:55,616 --> 04:00:56,150
THEMSELVES HAVE BECOME SO

4930
04:00:56,150 --> 04:00:56,751
STRINGENT AS YOU WRITE UP THE

4931
04:00:56,751 --> 04:01:03,090
STUDY TO MEET THE CRITERIA MAYBE

4932
04:01:03,090 --> 04:01:03,691
THEY COULD REQUIRE THAT FOR A

4933
04:01:03,691 --> 04:01:04,592
PUBLICATION THAT COULD BE

4934
04:01:04,592 --> 04:01:15,136
MOTIVATION TO BRING IT FORWARD.

4935
04:01:25,713 --> 04:01:26,280
>> THAT WAS ACTUALLY
SOMETHING I

4936
04:01:26,280 --> 04:01:26,914
WAS TRYING TO BRING OUT WITH THE

4937
04:01:26,914 --> 04:01:27,381
RECENT PUBLICATION AND

4938
04:01:27,381 --> 04:01:27,982
PEDIATRICS WHERE THEY TOOK THE

4939
04:01:27,982 --> 04:01:28,616
STUDIES AND PUT THEM UP AGAINST

4940
04:01:28,616 --> 04:01:29,217
THE 2 GUIDELINES SO WHICH ONES

4941
04:01:29,217 --> 04:01:35,590
ADHERED AND EMPHASIZED THE

4942
04:01:35,590 --> 04:01:36,224
ASPECTS OF THE GUIDANCE THAT ARE

4943
04:01:36,224 --> 04:01:36,858
POSITIVE AND THAT WE WOULD LIKE

4944
04:01:36,858 --> 04:01:37,391
TO SEE MORE OF AND TO SEE

4945
04:01:37,391 --> 04:01:47,835
INTERPRETING THE RESULTS.

4946
04:01:50,538 --> 04:01:50,938
>> I HAVE 2 QUESTIONS.

4947
04:01:50,938 --> 04:01:53,074
GIVEN EVERYTHING WE HAVE HEARD

4948
04:01:53,074 --> 04:01:58,980
TODAY AND THE POTENTIAL SPREAD

4949
04:01:58,980 --> 04:02:01,148
DO WE THINK AN INDIVIDUAL

4950
04:02:01,148 --> 04:02:06,053
PATIENT CONSENTED RANDOMIZED

4951
04:02:06,053 --> 04:02:08,256
STUDY CAN BE DONE VERSUS A

4952
04:02:08,256 --> 04:02:18,065
CENTER CROSSOVER?

4953
04:02:18,065 --> 04:02:18,633
THE OTHER QUESTION WHICH IS

4954
04:02:18,633 --> 04:02:22,036
PROMPTED BY THE PRESENTATION IS

4955
04:02:22,036 --> 04:02:22,737
GIVEN AND WHAT YOU HAVE LEARNED

4956
04:02:22,737 --> 04:02:28,776
ABOUT THE CHANGES OVER TIM

4957
04:02:28,776 --> 04:02:29,410
TIME, WHAT IS THE TIMING OF THE

4958
04:02:29,410 --> 04:02:30,044
INTERVENTION AND SHOULD THAT BE

4959
04:02:30,044 --> 04:02:34,615
FROM BIRTH OR OTHER TRIGGERS FOR

4960
04:02:34,615 --> 04:02:41,422
THE INTERVENTION?

4961
04:02:41,422 --> 04:02:47,194
>> THAT IS INTERESTING
BECAUSE

4962
04:02:47,194 --> 04:02:47,828
IF YOU WENT TO TARGET THE GROUP

4963
04:02:47,828 --> 04:02:48,462
AT THE HIGHEST INCIDENTS AND THE

4964
04:02:48,462 --> 04:02:51,032
WORST OUTCOME YOU SHOULD

4965
04:02:51,032 --> 04:02:51,933
PROBABLY WAIT A FEW WEEKS AND

4966
04:02:51,933 --> 04:03:00,675
THEN RANDOMIZE INTERESTINGLY THE

4967
04:03:00,675 --> 04:03:02,777
ORAL NOT ABSORBABLE ANTIBIOTICS

4968
04:03:02,777 --> 04:03:05,346
TRIALS WHAT START GIVING THEM AT

4969
04:03:05,346 --> 04:03:08,449
BIRTH GIVING THEM FOR A COUPLE

4970
04:03:08,449 --> 04:03:10,418
WEEKS RIGHT BEFORE CHILDREN

4971
04:03:10,418 --> 04:03:14,288
WOULD DEVELOP NEC.

4972
04:03:14,288 --> 04:03:14,889
SO THERE ARE ISSUES WHICHEVER

4973
04:03:14,889 --> 04:03:18,059
WAY YOU CHOOSE I WOULD LIKE TO

4974
04:03:18,059 --> 04:03:24,231
ASK INDUSTRY IN THE ROOM I HEARD

4975
04:03:24,231 --> 04:03:24,699
FROM SOMEBODY WHO WAS

4976
04:03:24,699 --> 04:03:25,299
CONSIDERING A NEW MOLECULE TO

4977
04:03:25,299 --> 04:03:31,839
PREVENT NEC AND WAS ENCOUNTERING

4978
04:03:31,839 --> 04:03:32,473
A LOT OF OPPOSITION IN THE NICU

4979
04:03:32,473 --> 04:03:39,814
AND GOVERNMENT TO RANDOMIZING

4980
04:03:39,814 --> 04:03:40,481
BECAUSE MOST OF THEM WANT TO GET

4981
04:03:40,481 --> 04:03:40,982
THAT CAN THEY ARE SUCH A

4982
04:03:40,982 --> 04:03:51,525
VULNERABLE POPULATION AND IT IS

4983
04:03:55,629 --> 04:03:56,063
SUCH A NEW DRUG IS THERE

4984
04:03:56,063 --> 04:03:56,497
PROFOUND A VERSION?

4985
04:03:56,497 --> 04:03:57,164
ABOUT 100 PEOPLE IN THIS ROOM AT

4986
04:03:57,164 --> 04:03:57,765
5 OF US WERE GOING TO HAVE IN

4987
04:03:57,765 --> 04:03:58,399
THE NEXT 60 DAYS A CATASTROPHIC

4988
04:03:58,399 --> 04:03:59,033
ABDOMINAL EVENT WE WOULD ALL BE

4989
04:03:59,033 --> 04:04:04,472
LINING UP TO BE RANDOMIZED.

4990
04:04:04,472 --> 04:04:05,006
BUT THERE SEEMS TO BE THE

4991
04:04:05,006 --> 04:04:05,573
APPROACH AVOIDANCE TO DOING

4992
04:04:05,573 --> 04:04:06,007
TRIALS WITH INFANTS?

4993
04:04:06,007 --> 04:04:13,814
AM I PERCEIVING THIS CORRECTLY?

4994
04:04:13,814 --> 04:04:14,582
>> I WOULD SAY DEPENDING
ON THE

4995
04:04:14,582 --> 04:04:17,351
RISK PROFILE OF THE PRODUCT.

4996
04:04:17,351 --> 04:04:24,959
IF THERE'S NOT A LOT OF RISK

4997
04:04:24,959 --> 04:04:25,426
THEN YOU COULD DO IT.

4998
04:04:25,426 --> 04:04:25,893
IT REALLY GOES BACK TO

4999
04:04:25,893 --> 04:04:27,194
EVERYTHING YOU DO IN NEONATOLOGY

5000
04:04:27,194 --> 04:04:37,538
WITH THE RISK RATIO.

5001
04:04:46,347 --> 04:04:46,914
>> YOU RAISE AN EXCELLENT
POINT

5002
04:04:46,914 --> 04:04:47,581
AND 1 OF THE THINGS I DO FOR FUN

5003
04:04:47,581 --> 04:04:48,215
IS INFECTION PREVENTION SO I AM

5004
04:04:48,215 --> 04:04:48,783
ACUTELY AWARE OF SOME OF THE

5005
04:04:48,783 --> 04:04:49,316
CHALLENGES OF INADVERTENT

5006
04:04:49,316 --> 04:04:53,120
COLONIZATION AND TRANSMISSION

5007
04:04:53,120 --> 04:04:53,721
AND IN SOME WAYS WE COULD USE

5008
04:04:53,721 --> 04:04:54,288
THAT TO OUR BENEFIT BUT I DO

5009
04:04:54,288 --> 04:04:57,091
THINK THAT HAVING RANDOMIZED

5010
04:04:57,091 --> 04:05:01,028
STUDIES IS SOMETHING WE SHOULD

5011
04:05:01,028 --> 04:05:01,996
LOOK MORE TOWARDS IT HELPS US

5012
04:05:01,996 --> 04:05:05,699
WITH NUMBERS.

5013
04:05:05,699 --> 04:05:06,767
BUT THE CHALLENGE IS WITH INBORN

5014
04:05:06,767 --> 04:05:13,274
AND OUTBOARD MAKE SURE YOU HAVE

5015
04:05:13,274 --> 04:05:13,841
A GOOD STATISTICIAN ON SPEED

5016
04:05:13,841 --> 04:05:16,243
DIAL TO HELP YOU THINKING

5017
04:05:16,243 --> 04:05:25,453
THROUGH THOSE ISSUES BUT SOME OF

5018
04:05:25,453 --> 04:05:26,053
THE STUDIES THAT SHOW THERE IS

5019
04:05:26,053 --> 04:05:26,654
COLONIZATION OF A PRODUCT WHEN

5020
04:05:26,654 --> 04:05:28,055
THAT WAS NOT ADMINISTERED IS

5021
04:05:28,055 --> 04:05:30,224
IMPORTANT AND SHOWS US WHAT IS

5022
04:05:30,224 --> 04:05:32,560
POSSIBLY REALLY HAPPENING WITH

5023
04:05:32,560 --> 04:05:36,764
HYGIENE IN THE NICU.

5024
04:05:36,764 --> 04:05:37,965
>> THERE ARE SOME
QUESTIONS IN

5025
04:05:37,965 --> 04:05:44,338
THE CHAT.

5026
04:05:44,338 --> 04:05:45,272
DID ANY OF THE RCT SHOW A CASE

5027
04:05:45,272 --> 04:05:50,778
THE PROBIOTIC SEPSIS TO

5028
04:05:50,778 --> 04:06:00,955
CALCULATE?

5029
04:06:05,326 --> 04:06:06,360
AND THEN THE NUMBER NEEDED TO

5030
04:06:06,360 --> 04:06:13,701
TREAT EFFICACY BEFORE THERE IS A

5031
04:06:13,701 --> 04:06:19,273
CASE OF SEPSIS.

5032
04:06:19,273 --> 04:06:20,307
I WILL JUST MENTIONED THIS WE

5033
04:06:20,307 --> 04:06:23,077
TALKED ABOUT THIS WE HAVE

5034
04:06:23,077 --> 04:06:29,750
CULTURE NEGATIVE SEPSIS.

5035
04:06:29,750 --> 04:06:30,351
WITH THE ANAEROBES THEY ARE

5036
04:06:30,351 --> 04:06:33,120
DIFFICULT TO GROW.

5037
04:06:33,120 --> 04:06:36,323
YOU GET ANAEROBIC AND AEROBIC

5038
04:06:36,323 --> 04:06:38,492
CULTURES.

5039
04:06:38,492 --> 04:06:39,126
BUT THAT WOULD NOT BE A PROBLEM

5040
04:06:39,126 --> 04:06:42,897
FROM A LABORATORY STANDPOINT I

5041
04:06:42,897 --> 04:06:48,435
AM GUESSING IT WOULD BE IN THE

5042
04:06:48,435 --> 04:06:50,971
HUNDREDS.

5043
04:06:50,971 --> 04:06:52,540
>> BASED ON VERY LITTLE

5044
04:06:52,540 --> 04:06:59,547
STATISTICS.

5045
04:06:59,547 --> 04:07:00,147
>> SO YOU MENTIONED THE
TRIAL

5046
04:07:00,147 --> 04:07:03,584
DESIGNS AND APPROACHES THAT

5047
04:07:03,584 --> 04:07:06,086
ALLOWS YOU TO CONSIDER PRIOR

5048
04:07:06,086 --> 04:07:08,222
EVIDENCE WITH THAT TREATMENT

5049
04:07:08,222 --> 04:07:12,493
EFFECT AND THE OUTCOME SO THERE

5050
04:07:12,493 --> 04:07:19,266
IS PRIOR EVIDENCE GOING DOWN

5051
04:07:19,266 --> 04:07:19,833
VERY SPECIFIC FOR A PRODUCT

5052
04:07:19,833 --> 04:07:21,769
BEING STUDY BUT YOU HAVE

5053
04:07:21,769 --> 04:07:24,605
THOUGHTS ON WHAT IS AVAILABLE TO

5054
04:07:24,605 --> 04:07:26,774
BE CONSIDERED IN TERMS OF USE OF

5055
04:07:26,774 --> 04:07:30,511
TRIAL DESIGNS GOING FORWARD AS

5056
04:07:30,511 --> 04:07:33,447
IT RELATES TO THE APPROACH IN

5057
04:07:33,447 --> 04:07:37,151
TERMS OF CONSIDERING?

5058
04:07:37,151 --> 04:07:42,122
>> AT LEAST AREA LOOK AT
THE

5059
04:07:42,122 --> 04:07:46,493
PRIOR EVIDENCE TO SEE WHAT I CAN

5060
04:07:46,493 --> 04:07:51,365
ESTIMATE TO DO ANALYSIS.

5061
04:07:51,365 --> 04:07:57,271
I WILL ASK FOR HELP ON THIS 1.

5062
04:07:57,271 --> 04:07:59,873
I THINK MORE INFORMATION IS

5063
04:07:59,873 --> 04:08:01,542
BETTER.

5064
04:08:01,542 --> 04:08:05,846
I WILL SAY FOR SOME POPULATIONS

5065
04:08:05,846 --> 04:08:12,319
NOW GOING DOWN AT 2022, 23, I

5066
04:08:12,319 --> 04:08:12,920
DON'T THINK THERE IS ANY PRIOR

5067
04:08:12,920 --> 04:08:15,556
EVIDENCE FOR THOSE POPULATIONS

5068
04:08:15,556 --> 04:08:17,191
WHO ARE THE HIGHEST POPULATIONS

5069
04:08:17,191 --> 04:08:22,396
AT RISK.

5070
04:08:22,396 --> 04:08:22,997
>> I'M NOT SURE I WILL
ANSWER

5071
04:08:22,997 --> 04:08:24,932
YOUR QUESTION BUT THE OTHER

5072
04:08:24,932 --> 04:08:26,934
ADVANTAGE IS AS YOU ARE GOING

5073
04:08:26,934 --> 04:08:30,437
THROUGH YOU CAN MAKE CHANGES

5074
04:08:30,437 --> 04:08:35,709
WITH THE DATA YOU ARE ACCRUING

5075
04:08:35,709 --> 04:08:36,844
SO IT MIGHT NOT HELP IN EVERY

5076
04:08:36,844 --> 04:08:42,750
SITUATION BUT WE NEED TO TAKE A

5077
04:08:42,750 --> 04:08:43,384
LOOK AT WHAT WE HAVE AND ASSESS

5078
04:08:43,384 --> 04:08:44,685
THAT AND APPLY IT IS MUCH AS

5079
04:08:44,685 --> 04:08:55,162
POSSIBLE TO MOVING FORWARD.

5080
04:08:55,362 --> 04:08:58,666
>> THIS WAS RELATED HOW
HAS THE

5081
04:08:58,666 --> 04:09:03,137
FDA APPROACHED STATISTICS AND

5082
04:09:03,137 --> 04:09:13,547
DESIGNS FOR DRUG TRIALS?

5083
04:09:15,249 --> 04:09:25,726
>> AND THAT HAS BEEN
APPROACHED.

5084
04:09:26,960 --> 04:09:27,494
>> I COULDN'T REALLY HEAR
THE

5085
04:09:27,494 --> 04:09:28,128
ENTIRE QUESTION BUT THE GIST OF

5086
04:09:28,128 --> 04:09:34,268
IT WAS FDA USING STATISTICS AND

5087
04:09:34,268 --> 04:09:34,902
THE APPROVAL OF OTHER PRODUCTS?

5088
04:09:34,902 --> 04:09:37,371
THE ANSWER IS YES AND IN FACT

5089
04:09:37,371 --> 04:09:41,108
YOU CAN FIND THAT IN 1 OF THE

5090
04:09:41,108 --> 04:09:48,449
FNT PRODUCTS

5091
04:09:48,449 --> 04:09:52,986
STATISTICS TO HELP WITH THE

5092
04:09:52,986 --> 04:09:57,191
EFFICACY ANALYSIS.

5093
04:09:57,191 --> 04:09:57,691
LOOK AT THE PRESCRIBING

5094
04:09:57,691 --> 04:09:58,292
INFORMATION OF SECTION 14 WILL

5095
04:09:58,292 --> 04:10:00,794
FIND THE DISCUSSION.

5096
04:10:00,794 --> 04:10:01,295
>> THERE WAS ADDITIONAL

5097
04:10:01,295 --> 04:10:05,199
LEARNINGS AND IT AS WELL.

5098
04:10:05,199 --> 04:10:10,571
SO WE WILL TAKE A BREAK THERE IS

5099
04:10:10,571 --> 04:10:14,441
A 10 MINUTE BREAK AT 2:40 P.M.

5100
04:10:14,441 --> 04:10:15,509
THANK YOU FOR YOUR

5101
04:10:15,509 --> 04:10:22,741
PARTICIPATION.

5102
04:10:24,327 --> 04:10:24,494
OKAY.

5103
04:10:24,494 --> 04:10:25,094
WILL COME BACK FROM THE BREAK.

5104
04:10:25,094 --> 04:10:32,235
WE HAVE 2 MORE PRESENTATIONS.

5105
04:10:32,235 --> 04:10:33,269
AND THEN WE WILL WRAP UP WITH

5106
04:10:33,269 --> 04:10:37,407
THE Q&A AND WE WILL HAVE
SOME

5107
04:10:37,407 --> 04:10:40,076
CLOSING REMARKS THE FIRST TALK

5108
04:10:40,076 --> 04:10:45,815
IS FROM DOCTOR JOSEPH NEU

5109
04:10:45,815 --> 04:10:46,382
TALKING ABOUT CHALLENGES AND

5110
04:10:46,382 --> 04:10:47,016
OPPORTUNITIES OF CONDUCTING THE

5111
04:10:47,016 --> 04:10:49,419
CLINICAL TRIAL WITH THE LDV WE

5112
04:10:49,419 --> 04:10:51,087
HAVE HEARD ABOUT THAT IN THE

5113
04:10:51,087 --> 04:11:01,330
PAST SESSION.

5114
04:11:03,399 --> 04:11:04,701
>> JUST TO START I WANT TO
THANK

5115
04:11:04,701 --> 04:11:06,803
ANDY FOR SETTING THE STAGE FOR

5116
04:11:06,803 --> 04:11:17,246
THIS FANTASTIC JOB OF THE

5117
04:11:18,681 --> 04:11:19,115
POTENTIAL CHALLENGES AND

5118
04:11:19,115 --> 04:11:19,682
OPPORTUNITIES SO HERE I WILL

5119
04:11:19,682 --> 04:11:20,249
TALK ABOUT AND ACTUAL TRIAL

5120
04:11:20,249 --> 04:11:20,850
WHERE WE WENT THROUGH SOME OF

5121
04:11:20,850 --> 04:11:21,284
THESE CHALLENGES AND

5122
04:11:21,284 --> 04:11:24,320
OPPORTUNITIES I WILL GET MY

5123
04:11:24,320 --> 04:11:33,329
DISCLOSURE SLIDE THE NAME OF THE

5124
04:11:33,329 --> 04:11:33,930
TRIAL IS CALLED THE CONNECTION

5125
04:11:33,930 --> 04:11:34,564
TRIAL I JUST WANT TO GIVE YOU A

5126
04:11:34,564 --> 04:11:35,164
HISTORICAL PERSPECTIVE WITH A

5127
04:11:35,164 --> 04:11:35,565
CONNECTION TRIAL.

5128
04:11:35,565 --> 04:11:36,632
THIS WAS INITIATED 12 YEARS

5129
04:11:36,632 --> 04:11:45,508
AGO.

5130
04:11:45,508 --> 04:11:46,175
SOME OF THE BASIS OR REASONS FOR

5131
04:11:46,175 --> 04:11:46,809
THIS WAS THE DATA THAT WE HAD AT

5132
04:11:46,809 --> 04:11:48,277
THE TIME WAS UNCLEAR WITH

5133
04:11:48,277 --> 04:11:51,547
SEVERAL ANALYSIS THAT WAS

5134
04:11:51,547 --> 04:11:52,982
PUBLISHED IN PEDIATRICS IN 2010

5135
04:11:52,982 --> 04:12:02,125
WHICH REALLY RAISED A LOT OF

5136
04:12:02,125 --> 04:12:02,725
INTEREST AND IN FACT IT WAS A

5137
04:12:02,725 --> 04:12:03,359
COMMENTARY ASSOCIATED WITH THAT

5138
04:12:03,359 --> 04:12:05,194
THAT SAID IF IT IS NOT UNETHICAL

5139
04:12:05,194 --> 04:12:07,330
IF WE DO NOT USE PROBIOTICS.

5140
04:12:07,330 --> 04:12:10,833
THAT WAS 2010.

5141
04:12:10,833 --> 04:12:21,344
SO IN 2013 OUR COLLEAGUES FROM

5142
04:12:24,280 --> 04:12:24,814
IBT HAD SOME DISCUSSIONS WITH

5143
04:12:24,814 --> 04:12:25,448
THE FDA AND INITIATION OF PHASE

5144
04:12:25,448 --> 04:12:35,925
2 TRIAL STARTED UNDER IMD 8

5145
04:12:50,039 --> 04:12:50,239
YEARS AGO.

5146
04:12:50,239 --> 04:12:50,773
THERE WERE A LOT OF SAFETY

5147
04:12:50,773 --> 04:12:51,407
CONCERNS ABOUT OTHER AGENTS AND

5148
04:12:51,407 --> 04:12:52,041
YOU HAVE HEARD THIS AND SEVERAL

5149
04:12:52,041 --> 04:12:52,675
LECTURES THE SAFETY CONCERNS AND

5150
04:12:52,675 --> 04:12:53,176
THE TRANSLOCATION OF THE

5151
04:12:53,176 --> 04:12:53,676
BACTERIA AND SOME BABIES

5152
04:12:53,676 --> 04:12:54,243
ACTUALLY DYING OF ASSOCIATED

5153
04:12:54,243 --> 04:12:54,844
WITH THE PROBIOTICS AND ALSO

5154
04:12:54,844 --> 04:12:55,411
SOME OF THE PRODUCTS BEING

5155
04:12:55,411 --> 04:13:00,149
CONTAMINATED AND MICRO- SIS WAS

5156
04:13:00,149 --> 04:13:00,650
1 OF THESE AND THEN MOST

5157
04:13:00,650 --> 04:13:01,250
RECENTLY FDA WARNINGS AFTER

5158
04:13:01,250 --> 04:13:08,324
SEPSIS AND DEATH.

5159
04:13:08,324 --> 04:13:08,958
STARTING ENROLLMENT PHASE III

5160
04:13:08,958 --> 04:13:09,458
SEVERAL YEARS AGO.

5161
04:13:09,458 --> 04:13:14,530
AND NOW THIS IS COMPLETED IN

5162
04:13:14,530 --> 04:13:22,138
AUGUST 2024.

5163
04:13:22,138 --> 04:13:22,772
I WILL SHOW YOU A LITTLE BIT OF

5164
04:13:22,772 --> 04:13:23,105
DATA ON THIS.

5165
04:13:23,105 --> 04:13:27,276
THE OBJECTIVES WAS TO EVALUATE

5166
04:13:27,276 --> 04:13:31,013
WHICH IS A LACTOBACILLUS SCREEN

5167
04:13:31,013 --> 04:13:34,517
VERSUS STERILE WATER PLACEBO IN

5168
04:13:34,517 --> 04:13:36,752
VLBW INFANTS.

5169
04:13:36,752 --> 04:13:37,720
WE LOOKED AT SAFETY AND

5170
04:13:37,720 --> 04:13:41,057
PREVENTION OF NECROTIZING

5171
04:13:41,057 --> 04:13:44,727
ENTEROCOLITIS, IMPROVED

5172
04:13:44,727 --> 04:13:48,464
SUSTAINED FEEDING INTOLERAN

5173
04:13:48,464 --> 04:13:49,098
INTOLERANCE, DECREASE OF

5174
04:13:49,098 --> 04:13:52,301
SEVERITY IN NEC AND REDUCTION OF

5175
04:13:52,301 --> 04:13:56,105
DEATH DUE TO ANY CAUSES AND

5176
04:13:56,105 --> 04:13:56,672
LENGTH OF HOSPITALIZATION OR

5177
04:13:56,672 --> 04:14:00,443
GROWTH OR OTHER MORBIDITIES.

5178
04:14:00,443 --> 04:14:01,744
NOW THE 2 PRIMARY OUTCOMES WERE

5179
04:14:01,744 --> 04:14:12,255
PREVENTION OF NEC AND IMPROVED

5180
04:14:15,358 --> 04:14:15,925
SUSTAINED FEEDING TOLERANCE AND

5181
04:14:15,925 --> 04:14:16,559
WE ADDED THE IMPROVED SUSTAINED

5182
04:14:16,559 --> 04:14:17,159
FEEDING TOLERANCE A FEW YEARS

5183
04:14:17,159 --> 04:14:17,793
BACK AFTER DISCUSSING THIS WITH

5184
04:14:17,793 --> 04:14:18,394
FDA AND WE DECIDED TO ADD THE

5185
04:14:18,394 --> 04:14:27,637
SECOND PRIMARY OUTCOME.

5186
04:14:27,637 --> 04:14:28,271
HERE IS THE PATIENT ENROLLMENT

5187
04:14:28,271 --> 04:14:28,871
IT IS A LARGE STUDY ALMOST 100

5188
04:14:28,871 --> 04:14:29,472
DIFFERENT INTENSIVE CARE UNITS

5189
04:14:29,472 --> 04:14:31,774
IN 10 DIFFERENT COUNTRIES 2186

5190
04:14:31,774 --> 04:14:42,285
BABIES SCREENED AND THEN THERE

5191
04:14:47,089 --> 04:14:47,657
WERE SOME EXCLUSIONS AND WE CAN

5192
04:14:47,657 --> 04:14:48,291
JUST GO THROUGH THE REASONS FOR

5193
04:14:48,291 --> 04:14:48,824
NOT BEING TREATED WITH THE

5194
04:14:48,824 --> 04:14:49,458
DISCONTINUATION OF TREATMENT AND

5195
04:14:49,458 --> 04:14:50,059
THEN WHEN YOU GET DOWN TO THE

5196
04:14:50,059 --> 04:14:52,762
BOTTOM YOU HAVE 925 BABIES

5197
04:14:52,762 --> 04:14:57,400
COMPLETED AND 892 IN THE PLAC 

5198
04:14:57,400 --> 04:15:04,974
PLACEBO.

5199
04:15:04,974 --> 04:15:05,441
SO OPERATIONALLY IT IS

5200
04:15:05,441 --> 04:15:05,741
CHALLENGING.

5201
04:15:05,741 --> 04:15:09,211
A SHORT TIME WINDOW TO OBTAIN

5202
04:15:09,211 --> 04:15:19,522
INFORMED CONSENT.

5203
04:15:21,924 --> 04:15:22,158
48 HOURS.

5204
04:15:22,158 --> 04:15:22,692
A LOT OF BABIES WERE BEING

5205
04:15:22,692 --> 04:15:23,326
TRANSFERRED AND WERE TRANSFERRED

5206
04:15:23,326 --> 04:15:23,926
OUT OF THE ORIGINAL INTENSIVE

5207
04:15:23,926 --> 04:15:24,226
CARE UNITS.

5208
04:15:24,226 --> 04:15:27,563
THERE WERE HETEROGENEOUS WAYS OF

5209
04:15:27,563 --> 04:15:28,097
WORKING AND CARE PRACTICES

5210
04:15:28,097 --> 04:15:32,568
BETWEEN COUNTRIES AND UNITS SO

5211
04:15:32,568 --> 04:15:33,269
JUST TO GIVE YOU AN EXAMPLE FOR

5212
04:15:33,269 --> 04:15:35,705
SUSTAINED FEEDING TOLERANCE WE

5213
04:15:35,705 --> 04:15:41,043
PROVIDED ALL OF THE UNITS WITH

5214
04:15:41,043 --> 04:15:44,246
THE RECOMMENDATIONS AND FEEDING

5215
04:15:44,246 --> 04:15:53,856
GUIDELINES.

5216
04:15:53,856 --> 04:15:54,490
IT WAS VERY INTERESTING HOW THE

5217
04:15:54,490 --> 04:15:55,024
DOGMA AND TRADITION OF THE

5218
04:15:55,024 --> 04:15:56,592
VARIOUS NEONATAL INTENSIVE CARE

5219
04:15:56,592 --> 04:15:58,060
UNITS WERE OVERWRITING THOSE

5220
04:15:58,060 --> 04:16:00,396
RECOMMENDATIONS.

5221
04:16:00,396 --> 04:16:05,735
IN ENROLLMENT OF PRETERM INFANTS

5222
04:16:05,735 --> 04:16:06,335
IN A VERY STRESSFUL SITUATION

5223
04:16:06,335 --> 04:16:09,438
AND ESPECIALLY WHEN YOU GET TO

5224
04:16:09,438 --> 04:16:12,608
THE INFANTS YOU HAVE FREQUENT

5225
04:16:12,608 --> 04:16:16,445
SERIOUS EVENTS AND THEY ARE

5226
04:16:16,445 --> 04:16:26,989
DIFFICULT TO SEPARATE FROM WHAT

5227
04:16:28,224 --> 04:16:28,791
IS USUALLY THERE IN THE FRAGILE

5228
04:16:28,791 --> 04:16:29,325
POPULATION OR IF THERE IS

5229
04:16:29,325 --> 04:16:29,925
ACTUALLY SOMETHING OR A SIGNAL

5230
04:16:29,925 --> 04:16:31,360
FROM THE AGENT.

5231
04:16:31,360 --> 04:16:38,501
SO ELIGIBILITY AGAIN BODY WEIGHT

5232
04:16:38,501 --> 04:16:39,035
BETWEEN 550 AND 100 GRAMS

5233
04:16:39,035 --> 04:16:43,105
GESTATIONAL AGE OF 22 THROUGH 23

5234
04:16:43,105 --> 04:16:43,672
WEEKS STARTING LESS THAN 48

5235
04:16:43,672 --> 04:16:48,978
HOURS OF AGE AND WE ALSO HAVE

5236
04:16:48,978 --> 04:16:49,678
PRETERM BIRTH WITHOUT IMMINENT

5237
04:16:49,678 --> 04:16:53,182
RISK OF DEATH TO WHOM ONLY

5238
04:16:53,182 --> 04:16:55,451
COMFORT CARE IS GIVEN.

5239
04:16:55,451 --> 04:17:02,925
EARLY SEPSIS ONLY INCLUDING

5240
04:17:02,925 --> 04:17:03,559
THOSE WITH BACTERIA IN THE BLOOD

5241
04:17:03,559 --> 04:17:04,660
OR MOTHERS WITH HIV CHROMOSOMAL

5242
04:17:04,660 --> 04:17:09,765
ABERRATIONS PLANNED

5243
04:17:09,765 --> 04:17:11,767
ADMINISTRATION OF OTHER

5244
04:17:11,767 --> 04:17:12,835
BACTERIAL PRODUCTS OR

5245
04:17:12,835 --> 04:17:17,506
PROBIOTICS.

5246
04:17:17,506 --> 04:17:23,546
JUST A LITTLE BIT OF INFORMATION

5247
04:17:23,546 --> 04:17:24,980
ABOUT LACTOBACILLUS A SINGLE

5248
04:17:24,980 --> 04:17:32,388
DOSE WAS GIVEN WITHIN 48 HOURS

5249
04:17:32,388 --> 04:17:33,022
OF BIRTH FROM POST MENSTRUAL AGE

5250
04:17:33,022 --> 04:17:39,628
OF 34 WEEKS PLUS 6 DAYS WITH 9

5251
04:17:39,628 --> 04:17:40,262
DAYS OF DOSING WITH A FOLLOW-UP

5252
04:17:40,262 --> 04:17:42,198
AT 40 WEEKS.

5253
04:17:42,198 --> 04:17:44,066
EACH DOSE WAS GIVEN THROUGH

5254
04:17:44,066 --> 04:17:49,271
GASTROINTESTINAL TUBE RANDOMIZED

5255
04:17:49,271 --> 04:17:51,006
TREATMENT AGAINST A STERILE

5256
04:17:51,006 --> 04:17:56,178
WATER PLACEBO AND DOUBLE-BLIND

5257
04:17:56,178 --> 04:17:59,615
NEITHER INTENSIVE CARE STAFF NOR

5258
04:17:59,615 --> 04:18:01,150
SPONSOR WAS INFORMED OF WHO GETS

5259
04:18:01,150 --> 04:18:10,960
WHAT AND WHO GOT WHAT WAS AFTER

5260
04:18:10,960 --> 04:18:11,594
THE LAST PATIENT WAS AFTER THEY

5261
04:18:11,594 --> 04:18:12,228
LEFT THE STUDY WE DID NOT DO THE

5262
04:18:12,228 --> 04:18:22,771
UNWINDING AND TELL LAST AUGUST.

5263
04:18:29,345 --> 04:18:29,845
BUT WE ENDED UP HAVING 551

5264
04:18:29,845 --> 04:18:32,114
INFANTS BETWEEN 50749 GRAMS 1351

5265
04:18:32,114 --> 04:18:34,884
INFANTS 750 THROUGH 1000 GRAMS

5266
04:18:34,884 --> 04:18:44,126
AND 215 FEMALES 50 PERCENT

5267
04:18:44,126 --> 04:18:44,693
CAUCASIANS 50 PERCENT BLACK

5268
04:18:44,693 --> 04:18:46,762
AFRICAN AMERICANS 27 PERCENT

5269
04:18:46,762 --> 04:18:49,165
C-SECTION 77 PERCENT.

5270
04:18:49,165 --> 04:18:53,702
AND THE GROUPS WERE WELL

5271
04:18:53,702 --> 04:19:03,879
BALANCED.

5272
04:19:04,680 --> 04:19:05,214
AND WITH THE OUTCOMES THIS IS

5273
04:19:05,214 --> 04:19:05,848
SOMETHING I JUST WANT TO MENTION

5274
04:19:05,848 --> 04:19:07,316
VERY BRIEFLY THE OUTCOMES HAVE

5275
04:19:07,316 --> 04:19:10,186
NOT BEEN YET SUBJECTED TO PEER

5276
04:19:10,186 --> 04:19:10,419
REVIEW.

5277
04:19:10,419 --> 04:19:12,454
HOPEFULLY WE WILL GET THIS

5278
04:19:12,454 --> 04:19:13,155
SUBMITTED AND YOU ARE SEEING

5279
04:19:13,155 --> 04:19:14,123
SOME OF THESE RESULTS FOR THE

5280
04:19:14,123 --> 04:19:17,092
FIRST TIME.

5281
04:19:17,092 --> 04:19:21,197
NO DIFFERENCE IN TERMS OF SAFETY

5282
04:19:21,197 --> 04:19:27,436
BETWEEN PLACEBO AND SEPSIS

5283
04:19:27,436 --> 04:19:27,937
ABDOMINAL DISTENTION AND

5284
04:19:27,937 --> 04:19:28,437
RESPIRATORY FAILURE AND

5285
04:19:28,437 --> 04:19:30,839
METABOLIC GOAL BALANCES.

5286
04:19:30,839 --> 04:19:34,210
HYPER OR HYPOGLYCEMIA, PULMONARY

5287
04:19:34,210 --> 04:19:41,217
HEMORRHAGE.

5288
04:19:41,217 --> 04:19:46,222
THIS IS THE INTENTION TO TREAT.

5289
04:19:46,222 --> 04:19:48,791
YOU CAN SEE THE AGENT VERSUS THE

5290
04:19:48,791 --> 04:19:55,097
PLACEBO.

5291
04:19:55,097 --> 04:19:56,298
THE P VALUE 0.248 THAT IS

5292
04:19:56,298 --> 04:20:00,636
SIGNIFICANT.

5293
04:20:00,636 --> 04:20:07,009
NEC DIAGNOSED AFTER 14 DAY

5294
04:20:07,009 --> 04:20:16,418
DAYS.7 PERCENT WITH THE P VALUE.

5295
04:20:16,418 --> 04:20:16,986
FROM THE PERSPECTIVE OF WHAT

5296
04:20:16,986 --> 04:20:21,056
HAPPENS IS FIRST COUPLE OF WEEKS

5297
04:20:21,056 --> 04:20:25,261
NUMBER 1 ONLY STARTING TO GIVE

5298
04:20:25,261 --> 04:20:26,228
THE AGENT IN THE FIRST COUPLE OF

5299
04:20:26,228 --> 04:20:30,299
WEEKS.

5300
04:20:30,299 --> 04:20:31,600
PLUS THE OTHER PROBLEM IS YOU

5301
04:20:31,600 --> 04:20:34,403
HAVE A LOT OF BABIES WITH

5302
04:20:34,403 --> 04:20:36,038
SPONTANEOUS INTESTINAL

5303
04:20:36,038 --> 04:20:41,176
PERFORATION THE NEW AGE OF

5304
04:20:41,176 --> 04:20:42,745
SPONTANEOUS INTESTINAL

5305
04:20:42,745 --> 04:20:44,747
PERFORATION AND FREQUENTLY THAT

5306
04:20:44,747 --> 04:20:52,187
IS DIAGNOSED AS NEC SO WHEN WE

5307
04:20:52,187 --> 04:20:53,422
TAKE THOSE BABIES OUT AND LOOK

5308
04:20:53,422 --> 04:20:53,922
AT THE 14 DAYS WE SEE A

5309
04:20:53,922 --> 04:20:58,294
DIFFERENCE TO LOOK AT THE BABIES

5310
04:20:58,294 --> 04:21:00,262
DIAGNOSED AS HAVING NEC BY X-RAY

5311
04:21:00,262 --> 04:21:08,203
WE SEE NO DIFFERENCE NOW HERE

5312
04:21:08,203 --> 04:21:15,044
ARE SOME SUB GROUPINGS I WILL

5313
04:21:15,044 --> 04:21:15,678
REPEAT A LITTLE OF WHAT I SAID.

5314
04:21:15,678 --> 04:21:16,445
FORCED -- -- POST 14 DAYS OR

5315
04:21:16,445 --> 04:21:17,046
SEEMS TO BE A DIFFERENCE FROM

5316
04:21:17,046 --> 04:21:20,616
THE ENTIRE GROUP.

5317
04:21:20,616 --> 04:21:23,252
LOOK AT X-RAY POST 14 DAYS.

5318
04:21:23,252 --> 04:21:25,821
REALLY NO DIFFERENCE.

5319
04:21:25,821 --> 04:21:28,991
THEN LOOK AT SURGICAL NEC.

5320
04:21:28,991 --> 04:21:34,997
THOSE WHO HAD TO GO TO SURGERY.

5321
04:21:34,997 --> 04:21:36,799
YOU SEE A SLIGHT SUGGESTION OF

5322
04:21:36,799 --> 04:21:42,538
THE P VALUE OF 1.2 6 PERCENT

5323
04:21:42,538 --> 04:21:48,544
POST 14 YOU SEE A VALUE OF 0.46

5324
04:21:48,544 --> 04:21:52,581
FAVORING THE SUBJECTS.

5325
04:21:52,581 --> 04:21:55,351
IF YOU LOOK AT NEC SURGERY OR

5326
04:21:55,351 --> 04:22:03,625
NEC DEATH OR POST 14 DAYS, WE

5327
04:22:03,625 --> 04:22:04,927
SEE A STATISTICAL

5328
04:22:04,927 --> 04:22:15,237
SIGNIFICANCE.018.

5329
04:22:15,637 --> 04:22:16,205
SAY FEEDING TOLERANCE SO WHAT IS

5330
04:22:16,205 --> 04:22:16,672
THE SUSTAINED FEEDING

5331
04:22:16,672 --> 04:22:16,939
TOLERANCE?

5332
04:22:16,939 --> 04:22:17,873
THERE IS SO MANY DEFINITIONS WE

5333
04:22:17,873 --> 04:22:21,276
ENDED UP MAKING OUR OWN

5334
04:22:21,276 --> 04:22:23,479
DEFINITION BUT WE MADE A VERY

5335
04:22:23,479 --> 04:22:26,115
STRICT DEFINITION MAY BE TOO

5336
04:22:26,115 --> 04:22:33,622
STRICT.

5337
04:22:33,622 --> 04:22:34,256
SO THE WAY WE DEFINED SUSTAINED

5338
04:22:34,256 --> 04:22:34,890
FEEDING TOLERANCE IS THE DEFINED

5339
04:22:34,890 --> 04:22:35,557
TIME FROM THE FIRST PERIOD OF 10

5340
04:22:35,557 --> 04:22:38,427
CONSECUTIVE DAYS WITH ENTERAL

5341
04:22:38,427 --> 04:22:40,195
FEEDINGS GREATER THAN

5342
04:22:40,195 --> 04:22:47,269
120 MILLILITERS WITH NO

5343
04:22:47,269 --> 04:22:47,870
NUTRITION AND 100-GRAM BODY

5344
04:22:47,870 --> 04:22:48,370
WEIGHT INCREASE.

5345
04:22:48,370 --> 04:22:58,814
AND THE ASTERISKS HERE THE

5346
04:23:06,355 --> 04:23:06,855
STATISTICIANS WANTED TO MAKE

5347
04:23:06,855 --> 04:23:07,389
SURE THAT WE PUT THIS INTO

5348
04:23:07,389 --> 04:23:07,923
CONTEXT OF COMPETING RISK

5349
04:23:07,923 --> 04:23:08,524
ANALYSIS TO UNEQUAL NUMBERS OF

5350
04:23:08,524 --> 04:23:09,024
DEATHS PRIOR TO REACHING

5351
04:23:09,024 --> 04:23:09,658
SUSTAINED FEEDING TOLERANCE AND

5352
04:23:09,658 --> 04:23:10,292
I WILL SHOW YOU ABOUT THE DEATH

5353
04:23:10,292 --> 04:23:10,526
SHORTLY.

5354
04:23:10,526 --> 04:23:11,026
BUT WHEN YOU LOOK AT THE

5355
04:23:11,026 --> 04:23:13,195
SUSTAINED FEEDING TOLERANCE IN

5356
04:23:13,195 --> 04:23:17,399
THE ENTIRE GROUP THERE IS A

5357
04:23:17,399 --> 04:23:20,569
DIFFERENCE OF ABOUT 2 DAYS WITH

5358
04:23:20,569 --> 04:23:27,910
A P VALUE 2076 WITH LESS THAN

5359
04:23:27,910 --> 04:23:38,420
750 GRAMS THE P VALUE.035 WITH

5360
04:23:39,555 --> 04:23:40,088
THE GROUP AND THEN THE OTHER 2

5361
04:23:40,088 --> 04:23:42,024
GROUPS 750 THROUGH 999 AND

5362
04:23:42,024 --> 04:23:43,559
1500 GRAMS NOT STATISTICALLY

5363
04:23:43,559 --> 04:23:46,929
SIGNIFICANTLY DIFFERENT.

5364
04:23:46,929 --> 04:23:54,503
MORTALITY.

5365
04:23:54,503 --> 04:23:55,103
THIS IS A CURVE THAT SHOWS THE

5366
04:23:55,103 --> 04:23:55,704
MORTALITY DIFFERENCES THE BLUE

5367
04:23:55,704 --> 04:24:03,178
WAS THE TREATMENT THE SINGLE IS

5368
04:24:03,178 --> 04:24:03,812
THE RED AND IN THE FIRST 2 WEEKS

5369
04:24:03,812 --> 04:24:05,781
WE SEE VERY LITTLE DIFFERENCE

5370
04:24:05,781 --> 04:24:07,583
BUT THEN WE START TO SEE

5371
04:24:07,583 --> 04:24:09,818
DIVERGENCE IT ENDS UP BEING

5372
04:24:09,818 --> 04:24:13,155
27 PERCENT DIFFERENCE IN

5373
04:24:13,155 --> 04:24:13,789
MORTALITY WITH -- -- BETWEEN THE

5374
04:24:13,789 --> 04:24:23,966
2 GROUPS.

5375
04:24:25,767 --> 04:24:26,301
SO WHAT MIGHT BE DRIVING THIS

5376
04:24:26,301 --> 04:24:26,568
MORTALITY?

5377
04:24:26,568 --> 04:24:27,135
WE ARE STILL NOT SURE BUT WE

5378
04:24:27,135 --> 04:24:27,936
HAVE BEEN DOING SOME SPECULATION

5379
04:24:27,936 --> 04:24:31,473
AND HERE WHEN WE LOOK AT THE

5380
04:24:31,473 --> 04:24:35,511
INTESTINAL PERFORATION'S WE SEE

5381
04:24:35,511 --> 04:24:39,114
6 IN THE IBP GROUP.

5382
04:24:39,114 --> 04:24:44,620
THIS IS NECROTIZING

5383
04:24:44,620 --> 04:24:45,220
ENTEROCOLITIS WITH INTESTINAL

5384
04:24:45,220 --> 04:24:45,754
PERFORATION AND 18 AND THE

5385
04:24:45,754 --> 04:24:54,463
PLACEBO GROUP.

5386
04:24:54,463 --> 04:24:55,097
SO THERE IS MORE IN THE PLACEBO

5387
04:24:55,097 --> 04:24:55,697
GROUP ALMOST TWICE AS MORE AND

5388
04:24:55,697 --> 04:24:56,331
CHOICES MANY HERE WHEN WE LOOK

5389
04:24:56,331 --> 04:24:57,666
AT CARDIORESPIRATORY PROBLEMS

5390
04:24:57,666 --> 04:25:03,505
SUCH AS DYSPLASIA WE SEE LESS

5391
04:25:03,505 --> 04:25:04,640
DYSPLASIA OF THE IBP GROUP THAN

5392
04:25:04,640 --> 04:25:09,278
THE PLACEBO GROUP.

5393
04:25:09,278 --> 04:25:11,780
INTRACRANIAL HEMORRHAGE IS NOT

5394
04:25:11,780 --> 04:25:13,749
DIFFERENT PULMONARY EMBOLI AND

5395
04:25:13,749 --> 04:25:16,919
AMMONIA THESE ARE NOT DIFFERENT

5396
04:25:16,919 --> 04:25:20,155
BUT IT IS OF INTEREST THAT THE

5397
04:25:20,155 --> 04:25:21,356
DYSPLASIA OF THE SEVERE

5398
04:25:21,356 --> 04:25:23,659
INTESTINAL INJURIES ARE

5399
04:25:23,659 --> 04:25:29,965
DIFFERENT AND SUGGESTING PERHAPS

5400
04:25:29,965 --> 04:25:31,233
A ROLE OF THE IBP SYSTEMIC

5401
04:25:31,233 --> 04:25:36,605
INFLAMMATORY RESPONSE OF THE

5402
04:25:36,605 --> 04:25:37,272
GASTROINTESTINAL TRACK AND THE

5403
04:25:37,272 --> 04:25:39,708
G.I. TRACT.

5404
04:25:39,708 --> 04:25:40,342
I WOULD LIKE TO CONCLUDE THIS IS

5405
04:25:40,342 --> 04:25:42,911
THE LARGEST STUDY EVER OF THE

5406
04:25:42,911 --> 04:25:46,715
LIFE BIO THERAPEUTIC PRODUCT IN

5407
04:25:46,715 --> 04:25:54,122
PREMATURE INFANTS.

5408
04:25:54,122 --> 04:25:54,623
IT IS TO BENEFIT NEC AND

5409
04:25:54,623 --> 04:25:55,324
SUSTAINED FEEDING TOLERANCE.

5410
04:25:55,324 --> 04:25:59,428
BUT REMEMBER IT IS AN AMBIGUOUS

5411
04:25:59,428 --> 04:26:06,401
CLINICAL DIAGNOSIS AND LESS A

5412
04:26:06,401 --> 04:26:06,935
LAPAROTOMY OR AUTOPSY ARE

5413
04:26:06,935 --> 04:26:07,202
PERFORMED.

5414
04:26:07,202 --> 04:26:08,003
THE SUSTAINED FEEDING TOLERANCE

5415
04:26:08,003 --> 04:26:10,572
WERE HAMPERED TO ADVOCATED AND

5416
04:26:10,572 --> 04:26:16,211
FEEDING PROTOCOLS A SIGNIFICANT

5417
04:26:16,211 --> 04:26:21,650
REDUCTION OF THE RISK OF DEATH

5418
04:26:21,650 --> 04:26:22,017
FROM ANY CAUSE.

5419
04:26:22,017 --> 04:26:22,584
AT THIS JUNCTURE WE HAVE NO

5420
04:26:22,584 --> 04:26:28,090
CONCERNS AS TO SAFETY.

5421
04:26:28,090 --> 04:26:30,659
AND LACTOBACILLUS WAS NEVER

5422
04:26:30,659 --> 04:26:36,264
FOUND IN CLINICAL SUSPICION FOR

5423
04:26:36,264 --> 04:26:36,832
SEPSIS SO WE KNOW THERE IS A

5424
04:26:36,832 --> 04:26:40,802
POSITIVE BENEFIT TO RISK FOR

5425
04:26:40,802 --> 04:26:41,403
PREMATURE INFANTS BORN WITH A

5426
04:26:41,403 --> 04:26:41,870
VERY LOW BIRTH WEIGHT.

5427
04:26:41,870 --> 04:26:46,408
THANK YOU FOR YOUR ATTENTION.

5428
04:26:46,408 --> 04:26:56,585
[APPLAUSE]

5429
04:26:58,320 --> 04:26:58,654
>> WHAT A POWERFUL

5430
04:26:58,654 --> 04:26:58,987
PRESENTATION.

5431
04:26:58,987 --> 04:27:05,894
THANK YOU THE NEXT PRESENTATION

5432
04:27:05,894 --> 04:27:11,967
IS BY DOCTOR STEFFAN STROMBERG.

5433
04:27:11,967 --> 04:27:13,268
HE WILL TALK TO US ABOUT

5434
04:27:13,268 --> 04:27:13,735
HIGHLIGHTS IN PRODUCT

5435
04:27:13,735 --> 04:27:17,272
DEVELOPMENT AND DIFFERENTIATING

5436
04:27:17,272 --> 04:27:17,906
FROM DRUGS AND DIETARY

5437
04:27:17,906 --> 04:27:22,444
SUPPLEMENTS.

5438
04:27:22,444 --> 04:27:27,315
>> THANK YOU.

5439
04:27:27,315 --> 04:27:28,817
I AM THE TENTH SPEAKER ON FRIDAY

5440
04:27:28,817 --> 04:27:30,786
AFTERNOON.

5441
04:27:30,786 --> 04:27:32,354
I WILL TELL YOU ABOUT WHY I AM

5442
04:27:32,354 --> 04:27:32,988
HERE.

5443
04:27:32,988 --> 04:27:41,797
I REPRESENT THE COMPANY.

5444
04:27:41,797 --> 04:27:42,431
THE FIRST THING YOU SHOULD KNOW

5445
04:27:42,431 --> 04:27:46,768
IS WE ARE A COMPANY CALLED IBT

5446
04:27:46,768 --> 04:27:48,603
AND WHEN WE STARTED THE COMPANY

5447
04:27:48,603 --> 04:27:51,773
IN 2013.

5448
04:27:51,773 --> 04:27:54,276
WE DID THAT BECAUSE WE WANTED TO

5449
04:27:54,276 --> 04:27:57,546
DEVELOP LIVE LBP.

5450
04:27:57,546 --> 04:28:05,087
I WAS WORKING FOR A COMPANY TO

5451
04:28:05,087 --> 04:28:09,024
DO DIETARY SUPPLEMENTS.

5452
04:28:09,024 --> 04:28:18,667
SO THEN WE CAN WORK THERE.

5453
04:28:18,667 --> 04:28:19,935
SINCE 2016 WE'VE BEEN ON THE

5454
04:28:19,935 --> 04:28:30,312
NASDAQ STOCK EXCHANGE.

5455
04:28:32,748 --> 04:28:33,181
IT ALL STARTED WITH THE

5456
04:28:33,181 --> 04:28:33,648
PUBLICATION FROM 2012.

5457
04:28:33,648 --> 04:28:34,249
HE HAD CONDUCTED A STUDY WITH

5458
04:28:34,249 --> 04:28:37,853
PLACEBO AND ACTED THERE'S

5459
04:28:37,853 --> 04:28:38,720
5 PERCENT NEC IN THE PLACEBO AND

5460
04:28:38,720 --> 04:28:45,427
THEN A 3 PERCENT SO THEN READING

5461
04:28:45,427 --> 04:28:50,665
A LITTLE BIT ALSO 2012 AND THIS

5462
04:28:50,665 --> 04:28:54,569
IS A HISTORIC CONTROLLED TRIAL

5463
04:28:54,569 --> 04:28:57,973
HERE WE SAW 15 PERCENT NEC AND

5464
04:28:57,973 --> 04:29:07,215
THEN THEY INTRODUCED AND THEN A

5465
04:29:07,215 --> 04:29:09,684
2 PERCENT NEC SO THEN I ASK

5466
04:29:09,684 --> 04:29:12,654
MYSELF WHAT IT IS NEC AND WHAT

5467
04:29:12,654 --> 04:29:14,890
IS PRETERM?

5468
04:29:14,890 --> 04:29:16,458
REMEMBER I AM THE ONLY 1 AND I'M

5469
04:29:16,458 --> 04:29:22,164
NOT AN MD.

5470
04:29:22,164 --> 04:29:24,399
SO THEN I SAW PICTURES OF NEC

5471
04:29:24,399 --> 04:29:29,004
AND PRETERM INFANTS AND I SAID

5472
04:29:29,004 --> 04:29:31,406
THIS LOOKS SEVERE SO I TOOK AN

5473
04:29:31,406 --> 04:29:38,413
AIRPLANE FOR THE FIRST TIME IN

5474
04:29:38,413 --> 04:29:41,817
2012 AND I ASKED EVERYTHING I

5475
04:29:41,817 --> 04:29:43,952
COULD ABOUT NECROTIZING

5476
04:29:43,952 --> 04:29:47,255
ENTEROCOLITIS.

5477
04:29:47,255 --> 04:29:48,356
AND THEN I CONTINUED TO READ

5478
04:29:48,356 --> 04:29:57,866
MORE AND AT THE END OF SAID FROM

5479
04:29:57,866 --> 04:29:58,767
NEC AND A TELL YOU BECAUSE YOU

5480
04:29:58,767 --> 04:30:01,169
ARE THE EXPERTS.

5481
04:30:01,169 --> 04:30:06,842
SO I CONCLUDE MY FINDINGS IN THE

5482
04:30:06,842 --> 04:30:07,642
TEXT AND I'M SAYING PRETERM

5483
04:30:07,642 --> 04:30:14,883
INFANTS NEED HELP AND ALSO THAT

5484
04:30:14,883 --> 04:30:15,483
THEY DON'T NEED MORE PROBLEMS.

5485
04:30:15,483 --> 04:30:16,017
THANK YOU AGREE WITH THAT.

5486
04:30:16,017 --> 04:30:17,552
I HOPE WE DO.

5487
04:30:17,552 --> 04:30:19,788
AND THAT MADE ME INTRIGUED TO GO

5488
04:30:19,788 --> 04:30:24,593
ON.

5489
04:30:24,593 --> 04:30:25,193
I THEN WAS THINKING ABOUT THE

5490
04:30:25,193 --> 04:30:31,633
CAUSE OF DEATH AND HERE YOU SEE

5491
04:30:31,633 --> 04:30:35,570
COLORS AND HOW THEY ARE CHANG 

5492
04:30:35,570 --> 04:30:35,837
CHANGING.

5493
04:30:35,837 --> 04:30:37,873
IN THE BEGINNING OF LIFE ON THE

5494
04:30:37,873 --> 04:30:41,977
LEFT YOU CAN SEE THE BABIES ARE

5495
04:30:41,977 --> 04:30:42,410
DYING EARLY IN LIFE.

5496
04:30:42,410 --> 04:30:44,145
THE FIRST 12 HOURS IN THE FIRST

5497
04:30:44,145 --> 04:30:47,315
WEEK IT IS BLUE.

5498
04:30:47,315 --> 04:30:49,251
THEN LATELY YOU SEE OTHER COLORS

5499
04:30:49,251 --> 04:30:54,990
INCLUDING PURPLE FOR NEC.

5500
04:30:54,990 --> 04:30:55,624
THAT I AM THINKING OKAY THERE IS

5501
04:30:55,624 --> 04:30:58,260
SOMETHING IN THE BEGINNING AND

5502
04:30:58,260 --> 04:30:59,794
THEN SOMETHING AFTER THE FIRST

5503
04:30:59,794 --> 04:31:06,101
WEEK AND THEN BLUE.

5504
04:31:06,101 --> 04:31:06,568
BLUE BABIES THEY NEED

5505
04:31:06,568 --> 04:31:07,669
CIRCULATION AND OXYGEN IN THE

5506
04:31:07,669 --> 04:31:09,471
BEGINNING OF LIFE.

5507
04:31:09,471 --> 04:31:12,107
ONCE THEY HAVE ESTABLISHED THAT

5508
04:31:12,107 --> 04:31:14,109
THEN THEY NEED

5509
04:31:14,109 --> 04:31:15,143
ENERGY, NUTRITION, THEY NEED TO

5510
04:31:15,143 --> 04:31:17,913
BE FED.

5511
04:31:17,913 --> 04:31:19,314
SO THE COMPLICATIONS AND THE

5512
04:31:19,314 --> 04:31:21,449
REASONS WHY SHIFTED AFTER A WEEK

5513
04:31:21,449 --> 04:31:24,286
OR 2.

5514
04:31:24,286 --> 04:31:34,829
I KEPT READING A LITTLE BIT AND

5515
04:31:39,968 --> 04:31:40,735
SINCE KENNEDY AND THE SIXTIES

5516
04:31:40,735 --> 04:31:41,269
AND TELL TODAY AND SEEING

5517
04:31:41,269 --> 04:31:42,203
SEVERAL BREAKTHROUGHS WITH THE

5518
04:31:42,203 --> 04:31:45,440
INCUBATOR AND BREAST-FEEDING

5519
04:31:45,440 --> 04:31:47,709
SURFACTANTS AND OTHER FACTORS

5520
04:31:47,709 --> 04:31:57,285
HAVE BEEN ADDED BUT I WAS

5521
04:31:57,285 --> 04:31:57,919
SITTING DOWN AND THINKING MAYBE

5522
04:31:57,919 --> 04:32:08,430
IT IS TIME TO ACTUALLY PRODUCE

5523
04:32:09,764 --> 04:32:09,965
IBP 9414.

5524
04:32:09,965 --> 04:32:10,498
AND HAVE AN EFFECT ON GUT

5525
04:32:10,498 --> 04:32:12,033
FUNCTION AND MAYBE IF WE HAVE

5526
04:32:12,033 --> 04:32:15,537
THAT GOING BACK TO THIS PICTURE

5527
04:32:15,537 --> 04:32:16,171
IF WE IMPROVE GUT FUNCTION MAYBE

5528
04:32:16,171 --> 04:32:23,845
WE REDUCE MORTALITY.

5529
04:32:23,845 --> 04:32:30,986
SO THEN REMEMBER I WAS WORKING

5530
04:32:30,986 --> 04:32:31,920
FOR THE COMPANY IT IS A DIETARY

5531
04:32:31,920 --> 04:32:35,890
SUPPLEMENT COMPANY AND THEN WE

5532
04:32:35,890 --> 04:32:38,293
REALIZE THERE ARE NO THERAPIES

5533
04:32:38,293 --> 04:32:39,160
AVAILABLE FOR MEDICAL NEED AND

5534
04:32:39,160 --> 04:32:44,299
THEN WE WERE THINKING GO TO

5535
04:32:44,299 --> 04:32:54,743
DIETARY SUPPLEMENT I WILL

5536
04:32:56,778 --> 04:32:57,345
DISCUSS THAT TODAY IT SHOULD BE

5537
04:32:57,345 --> 04:32:57,946
CONSIDERED SOME PEOPLE SAY YES

5538
04:32:57,946 --> 04:32:58,580
SOME SAY NO BUT WE LOOKED AT THE

5539
04:32:58,580 --> 04:32:59,180
PRETERM INFANTS THESE ARE THE

5540
04:32:59,180 --> 04:33:00,949
POPULATION THAT WE WILL TREAT

5541
04:33:00,949 --> 04:33:01,483
AND WE JUST SAY THEY ARE

5542
04:33:01,483 --> 04:33:03,585
EXTREMELY VULNERABLE AND TOOK A

5543
04:33:03,585 --> 04:33:09,090
POSITION.

5544
04:33:09,090 --> 04:33:09,724
THE IBT POSITION WAS AND REMAINS

5545
04:33:09,724 --> 04:33:10,191
CLEAR PHARMACOLOGICAL

5546
04:33:10,191 --> 04:33:11,626
DEVELOPMENT IS THE RIGHT PATH

5547
04:33:11,626 --> 04:33:15,430
FORWARD.

5548
04:33:15,430 --> 04:33:15,997
THAT IS SUBJECTIVE THINKING.

5549
04:33:15,997 --> 04:33:19,234
BUT THIS IS WHAT WE DO AT IBT

5550
04:33:19,234 --> 04:33:20,702
SINCE I AM THE CEO I REPRESENT

5551
04:33:20,702 --> 04:33:26,741
THE COMPANY IN FULL.

5552
04:33:26,741 --> 04:33:27,342
EVERYBODY SAYS I CANNOT SPEAK

5553
04:33:27,342 --> 04:33:28,410
FOR THE ORGANIZATION BUT I CAN

5554
04:33:28,410 --> 04:33:37,886
SO WE DO DEVELOPMENT SO WHAT IS

5555
04:33:37,886 --> 04:33:38,987
IBP?

5556
04:33:38,987 --> 04:33:49,464
I FORWARD THIS SO WE LOOK AT

5557
04:33:50,365 --> 04:33:50,865
THIS IT ONLY HAS 3 LEGS AND

5558
04:33:50,865 --> 04:33:53,368
THERE IS A REASON FOR THAT AND

5559
04:33:53,368 --> 04:33:59,874
THE LEGS FOR SAFETY PRODUCTION

5560
04:33:59,874 --> 04:34:00,475
WE CAN CALL THEM OTHER THINGS

5561
04:34:00,475 --> 04:34:01,543
BUT THEY ARE EQUALLY IMPORTANT

5562
04:34:01,543 --> 04:34:05,046
IF YOU BREAK OFF 1 LEG THE STOOL

5563
04:34:05,046 --> 04:34:09,050
WILL TIP.

5564
04:34:09,050 --> 04:34:11,719
AND THEN WE DO CLINICAL TRIALS.

5565
04:34:11,719 --> 04:34:14,122
PUBLISHED IN THE NEW ENGLAND

5566
04:34:14,122 --> 04:34:15,390
JOURNAL.

5567
04:34:15,390 --> 04:34:21,529
AND IT IS ALL ON EFFICACY.

5568
04:34:21,529 --> 04:34:21,863
WE WANT THAT.

5569
04:34:21,863 --> 04:34:22,464
IT IS GREAT TO HAVE AN EFFECT.

5570
04:34:22,464 --> 04:34:24,799
THAT'S WHAT WE WANT.

5571
04:34:24,799 --> 04:34:27,335
I WANT TO GIVE YOU EFFICACY SO

5572
04:34:27,335 --> 04:34:37,045
YOU BUY MY PRODUCT.

5573
04:34:37,045 --> 04:34:37,579
BUT I ALSO NEED TO LOOK AT

5574
04:34:37,579 --> 04:34:38,179
SAFETY ABSOLUTELY WE WILL COME

5575
04:34:38,179 --> 04:34:38,713
BACK TO THAT BUT I WANT TO

5576
04:34:38,713 --> 04:34:48,523
HIGHLIGHT PRODUCTION.

5577
04:34:48,523 --> 04:34:49,090
BECAUSE IF I A DOCUMENT THE

5578
04:34:49,090 --> 04:34:49,691
EFFECTS AROUND EFFICACY AROUND

5579
04:34:49,691 --> 04:34:50,325
CLINICAL TRIALS AND THAT CREDIT

5580
04:34:50,325 --> 04:34:51,426
IS CHANGING WITH TIME THEN IS

5581
04:34:51,426 --> 04:34:58,833
NOT RELEVANT ANYMORE IT IS OLD

5582
04:34:58,833 --> 04:34:59,434
DATA IF MY PRODUCT IS CHANGING

5583
04:34:59,434 --> 04:35:00,301
WITH TIME THE PRODUCT THAT I AM

5584
04:35:00,301 --> 04:35:03,304
OFFERING YOU.

5585
04:35:03,304 --> 04:35:07,408
WE NEED TO LOOK AT THAT

5586
04:35:07,408 --> 04:35:07,942
PRODUCTION THERE ARE OTHER

5587
04:35:07,942 --> 04:35:13,848
ASPECTS FOR EXAMPLE THE

5588
04:35:13,848 --> 04:35:14,682
PRODUCTION INVOLVES A MISTAKE

5589
04:35:14,682 --> 04:35:25,126
AND LET'S SAY SALMONELLA.

5590
04:35:27,228 --> 04:35:27,795
THAT IS SAFETY YOU READ AND THE

5591
04:35:27,795 --> 04:35:28,429
PUBLICATIONS AND THE JOURNALS WE

5592
04:35:28,429 --> 04:35:29,063
DON'T SEE SIDE EFFECTS BUT THAT

5593
04:35:29,063 --> 04:35:29,697
WAS FOR THE PRODUCT THAT DID NOT

5594
04:35:29,697 --> 04:35:30,331
CONTAIN THE SALMONELLA.

5595
04:35:30,331 --> 04:35:34,169
SO THAT IS NOT TRUE ANYMORE AND

5596
04:35:34,169 --> 04:35:35,737
THEREFORE WE NEED TO PAY VERY

5597
04:35:35,737 --> 04:35:38,706
MUCH ATTENTION TO THE PRODUCTION

5598
04:35:38,706 --> 04:35:47,348
AND ALSO WE KNOW IT IS ALIVE THE

5599
04:35:47,348 --> 04:35:57,091
L STANDS FOR LIVE AND I KNOW

5600
04:35:57,091 --> 04:35:57,592
THAT IT DIES AND WATER.

5601
04:35:57,592 --> 04:35:58,226
SO IF I PRODUCE IT IN A WAY WITH

5602
04:35:58,226 --> 04:35:58,860
A LITTLE BIT OF WATER IS ENTERED

5603
04:35:58,860 --> 04:36:00,028
INTO THE PRODUCT, I AM NOT

5604
04:36:00,028 --> 04:36:05,400
GIVING YOU LIVE BIO THERAPEUTIC

5605
04:36:05,400 --> 04:36:08,670
PRODUCT IT IS DEAD.

5606
04:36:08,670 --> 04:36:14,943
AND THEN THE EFFICACY DOESN'T

5607
04:36:14,943 --> 04:36:20,315
WORK SO I WANT TO HIGHLIGHT

5608
04:36:20,315 --> 04:36:20,915
BECAUSE I KNOW FDA AND OTHERS

5609
04:36:20,915 --> 04:36:21,549
THEN YOU LOOK AT THIS FROM THE 3

5610
04:36:21,549 --> 04:36:24,485
LEGS PRINCIPAL THAT IS GOOD FOR

5611
04:36:24,485 --> 04:36:26,821
EVERYBODY WHO WANTS TO USE THE

5612
04:36:26,821 --> 04:36:31,626
PRODUCT SO LOOK AT SAFETY AND

5613
04:36:31,626 --> 04:36:37,498
THIS IS THE REASON WE STARTED

5614
04:36:37,498 --> 04:36:38,700
LBP WE COULD NOT SEE IF THEY HAD

5615
04:36:38,700 --> 04:36:40,301
PICKED UP THE SAFETY SIGNALS AND

5616
04:36:40,301 --> 04:36:46,007
I JUST READ SOMETHING FROM THE

5617
04:36:46,007 --> 04:36:48,009
TOOLKIT THAT WAS PUBLISHED LAST

5618
04:36:48,009 --> 04:36:51,946
YEAR.

5619
04:36:51,946 --> 04:36:53,181
THEY SAY MOST OF THE TRIAL IS

5620
04:36:53,181 --> 04:36:57,252
DONE ON PRETERM INFANTS DO NOT

5621
04:36:57,252 --> 04:36:57,819
FULLY MONITOR OR REPORT SIDE

5622
04:36:57,819 --> 04:37:02,924
EFFECTS.

5623
04:37:02,924 --> 04:37:03,491
I AGREE BUT I ALSO READ THE

5624
04:37:03,491 --> 04:37:03,725
PAPERS.

5625
04:37:03,725 --> 04:37:14,035
WHAT DOES IT MEAN?

5626
04:37:14,836 --> 04:37:16,070
BUT I AM JUST LOOKING AT THE

5627
04:37:16,070 --> 04:37:19,107
PICTURE OF THE ICEBERG YOU SEE

5628
04:37:19,107 --> 04:37:19,674
WHAT YOU SEE BUT BENEATH THE

5629
04:37:19,674 --> 04:37:28,916
SURFACE THERE MIGHT BE MORE.

5630
04:37:28,916 --> 04:37:29,450
SO THEREFORE I THINK IT'S

5631
04:37:29,450 --> 04:37:30,051
IMPORTANT THAT YOU TRY TO LOOK

5632
04:37:30,051 --> 04:37:30,685
BENEATH THE SURFACE TO SEE WHAT

5633
04:37:30,685 --> 04:37:31,519
THE ICEBERG HOLDS UNDERNEATH THE

5634
04:37:31,519 --> 04:37:41,663
SURFACE.

5635
04:37:49,771 --> 04:37:50,338
SO PHARMACEUTICALS IN GENERAL WE

5636
04:37:50,338 --> 04:37:50,938
TRIED TO BALANCE THE RISK AND

5637
04:37:50,938 --> 04:37:51,539
BENEFITS AND IF THEY OUTWEIGH

5638
04:37:51,539 --> 04:37:52,173
THE RISK IT IS GOOD THE DRUG IS

5639
04:37:52,173 --> 04:37:52,807
GOOD OR IS GOOD TO PRESCRIBE THE

5640
04:37:52,807 --> 04:37:55,777
DRUG IT IS GOOD IF THE RISKS

5641
04:37:55,777 --> 04:37:57,879
OUTWEIGH THE BENEFITS THEN IT IS

5642
04:37:57,879 --> 04:38:00,815
BAD.

5643
04:38:00,815 --> 04:38:01,449
WE SHOULD NOT USE IT AND THEN WE

5644
04:38:01,449 --> 04:38:03,718
USE SCALE OVER AND OVER.

5645
04:38:03,718 --> 04:38:10,258
I'M NOT BUT I THINK FDA IS USING

5646
04:38:10,258 --> 04:38:11,059
IT AND CDC AND DOCTORS USE IT

5647
04:38:11,059 --> 04:38:14,162
EVERY DAY.

5648
04:38:14,162 --> 04:38:14,796
YOU LOOK WHEN YOU APPROVE A DRUG

5649
04:38:14,796 --> 04:38:16,731
IT FDA LOOK AT THE RISK AND

5650
04:38:16,731 --> 04:38:23,171
BENEFIT AND THEN YOU DECIDE.

5651
04:38:23,171 --> 04:38:30,011
?

5652
04:38:30,011 --> 04:38:30,645
SO THEN TO THINK WHAT SHOULD WE

5653
04:38:30,645 --> 04:38:30,812
SAY?

5654
04:38:30,812 --> 04:38:31,379
ANTIBIOTICS IS A GROUP IT IS

5655
04:38:31,379 --> 04:38:32,280
VERY GOOD IF SOMEONE HAS AN

5656
04:38:32,280 --> 04:38:34,248
INFECTION BUT IT'S VERY BAD IF

5657
04:38:34,248 --> 04:38:37,985
WE USE THEM EVERY DAY SO ARE

5658
04:38:37,985 --> 04:38:38,386
THEY GOOD OR BAD?

5659
04:38:38,386 --> 04:38:48,596
IT DEPENDS.

5660
04:38:51,866 --> 04:38:52,467
AND THEN WHEN PRESCRIBED I KNOW

5661
04:38:52,467 --> 04:38:53,101
WHAT THE PACKAGING SAID AND YOU

5662
04:38:53,101 --> 04:38:53,701
READ ALL THE WARNINGS AND THE

5663
04:38:53,701 --> 04:38:54,168
TEXT FROM FDA AND THE

5664
04:38:54,168 --> 04:38:54,736
MANUFACTURERS AND THEN YOU

5665
04:38:54,736 --> 04:38:56,337
DECIDE I THINK I WILL PRESCRIBE

5666
04:38:56,337 --> 04:39:01,542
THIS AND THEN THE BABY OR

5667
04:39:01,542 --> 04:39:02,076
PATIENT COMES BACK YOU MAY

5668
04:39:02,076 --> 04:39:03,811
CHANGE THE MEDICATION FOR SIDE

5669
04:39:03,811 --> 04:39:09,851
EFFECTS.

5670
04:39:09,851 --> 04:39:10,385
SO AGAIN WHAT IS OUR ROLE?

5671
04:39:10,385 --> 04:39:16,891
IT IS PRETTY SIMPLE.

5672
04:39:16,891 --> 04:39:26,501
WE WANT TO WITH THE BABIES

5673
04:39:26,501 --> 04:39:36,444
LOOKING OVER AT DOCTOR PATEL AND

5674
04:39:36,444 --> 04:39:37,078
YOU CAN SEE THAT WE WANT TO TAKE

5675
04:39:37,078 --> 04:39:37,678
OUT THE REASONS TO REDUCE THE

5676
04:39:37,678 --> 04:39:43,951
DEATH OF THE BABIES WE ARE

5677
04:39:43,951 --> 04:39:44,719
TRYING NOT TO REMOVE THE SIDE

5678
04:39:44,719 --> 04:39:45,887
EFFECTS OR SAFETY CONCERNS BUT

5679
04:39:45,887 --> 04:39:56,264
WE ARE TRYING SO REALLY I WOULD

5680
04:39:56,264 --> 04:39:56,864
LIKE TO RAISE THAT ICEBERG OUT

5681
04:39:56,864 --> 04:39:57,498
OF THE WATER SO WE CAN ALL LOOK

5682
04:39:57,498 --> 04:39:58,032
AT WHAT THE DRUG IS DOING.

5683
04:39:58,032 --> 04:40:01,269
LAST TALKING ABOUT PRODUCTION

5684
04:40:01,269 --> 04:40:05,840
AND I MADE A VERY SIMPLE PICTURE

5685
04:40:05,840 --> 04:40:07,341
WE WANT TO KEEP THE LIVING

5686
04:40:07,341 --> 04:40:11,446
BACTERIA INSIDE THE PRODUCT BUT

5687
04:40:11,446 --> 04:40:12,413
KEEP THE PATHOGENS ON THE

5688
04:40:12,413 --> 04:40:18,820
OUTSIDE THAT'S IMPORTANT.

5689
04:40:18,820 --> 04:40:23,090
SO 12 YEARS AGO WE STARTED THIS

5690
04:40:23,090 --> 04:40:33,167
IS A SUMMARY OF 12 YEARS WE HAVE

5691
04:40:33,167 --> 04:40:33,801
BEEN WORKING IN 15 COUNTRIES AND

5692
04:40:33,801 --> 04:40:34,335
WE HAVE ENROLLED OVER 2000

5693
04:40:34,335 --> 04:40:39,040
PATIENTS IN THE TRIAL AND THE

5694
04:40:39,040 --> 04:40:49,450
COST IS $110 MILLION SO FAR.

5695
04:40:49,450 --> 04:40:53,921
SO WHEN I WAS INVITED TO SPEAK

5696
04:40:53,921 --> 04:40:57,291
THE CDC ASKED ME TELL ME ABOUT

5697
04:40:57,291 --> 04:41:00,828
THE CHALLENGE.

5698
04:41:00,828 --> 04:41:04,932
I'M HAPPY TO DO SO.

5699
04:41:04,932 --> 04:41:08,769
AND THIS IS NOT PART OF YOUR

5700
04:41:08,769 --> 04:41:09,570
JOB.

5701
04:41:09,570 --> 04:41:11,038
YOU DIDN'T EVEN DO ANYTHING

5702
04:41:11,038 --> 04:41:12,707
ABOUT THIS I'M JUST TELLING YOU

5703
04:41:12,707 --> 04:41:14,275
WHY.

5704
04:41:14,275 --> 04:41:18,379
BUT FIRST WHEN WE DO CLINICAL

5705
04:41:18,379 --> 04:41:19,881
STUDIES AT HIGH QUANTITY IT COST

5706
04:41:19,881 --> 04:41:25,786
A LOT OF MONEY.

5707
04:41:25,786 --> 04:41:26,420
AND IBT DOES NOT SELL ANYTHING.

5708
04:41:26,420 --> 04:41:26,954
WE HAVE NO INCOME.

5709
04:41:26,954 --> 04:41:27,922
IF WE WANT TO SPEND MONEY WE

5710
04:41:27,922 --> 04:41:30,324
NEED TO HAVE THE MONEY.

5711
04:41:30,324 --> 04:41:36,130
IT'S NOT THAT EASY YOU CAN SEE

5712
04:41:36,130 --> 04:41:41,269
WHAT WE HAVE DONE PEOPLE HAVE

5713
04:41:41,269 --> 04:41:47,508
GIVEN US MONEY SO WE START WITH

5714
04:41:47,508 --> 04:41:51,045
THE ORPHAN DRUG RESIGNATION AND

5715
04:41:51,045 --> 04:41:51,679
THEN WITH $5 MILLION AND THEN IT

5716
04:41:51,679 --> 04:41:52,580
HAS CONTINUED THROUGH THE

5717
04:41:52,580 --> 04:41:57,084
DEVELOPMENT.

5718
04:41:57,084 --> 04:41:59,620
IS A THAT HITS THE X AXIS IT IS

5719
04:41:59,620 --> 04:42:02,156
OVER.

5720
04:42:02,156 --> 04:42:05,560
SO IT'S MY JOB TO KEEP A LINE ON

5721
04:42:05,560 --> 04:42:06,160
- - KEEP AN EYE ON THE GREEN

5722
04:42:06,160 --> 04:42:08,029
LINE HOW WE RELATE TO THE

5723
04:42:08,029 --> 04:42:08,296
INVESTORS.

5724
04:42:08,296 --> 04:42:11,232
THIS IS MY EVERYDAY WORK NOTHING

5725
04:42:11,232 --> 04:42:13,301
TO DO A SCIENCE OR BABIES

5726
04:42:13,301 --> 04:42:16,604
RUNNING A COMPANY.

5727
04:42:16,604 --> 04:42:19,273
SO ANOTHER FACTOR OF WHAT I

5728
04:42:19,273 --> 04:42:22,376
WOULD SAY IS OUTSIDE OF OUR

5729
04:42:22,376 --> 04:42:28,482
CONTROL AND LOOKING AT COVID AND

5730
04:42:28,482 --> 04:42:34,722
DEATH DUE TO COVID AND WHAT YOU

5731
04:42:34,722 --> 04:42:36,157
CAN SEE THE BLUE LINE THAT

5732
04:42:36,157 --> 04:42:39,994
RECRUITMENT INTO THE STUDY IS

5733
04:42:39,994 --> 04:42:47,568
PRETTY MUCH STANDING STILL WHEN

5734
04:42:47,568 --> 04:42:48,035
WE HAVE PEAKS OF COVID

5735
04:42:48,035 --> 04:42:49,437
OUTBREAKS.

5736
04:42:49,437 --> 04:42:51,806
WHY IS THAT?

5737
04:42:51,806 --> 04:42:54,342
HOSPITALS HOW DO WE GET FULL

5738
04:42:54,342 --> 04:42:58,746
CONSENT?

5739
04:42:58,746 --> 04:42:59,380
WE THOUGHT THE STUDY WOULD TAKE

5740
04:42:59,380 --> 04:43:09,857
2 YEARS BUT IT TOOK 5 YEARS.

5741
04:43:17,431 --> 04:43:17,865
NUMBER 3 HAS TO DO WITH

5742
04:43:17,865 --> 04:43:18,499
PRODUCTION AGAIN AND THAT IS IN

5743
04:43:18,499 --> 04:43:19,066
A SIMPLE WAY YOU CAN DIVIDE

5744
04:43:19,066 --> 04:43:19,667
DRUGS INTO 2 TYPES ORAL DRUGS

5745
04:43:19,667 --> 04:43:20,334
AND INJECTABLE DRUGS AND ORAL

5746
04:43:20,334 --> 04:43:23,237
DRUGS YOU TAKE WITH YOUR HAND

5747
04:43:23,237 --> 04:43:29,744
AND INJECTABLES WE INJECT AND IF

5748
04:43:29,744 --> 04:43:30,378
YOU LOOK BEHIND THE SCENES INTO

5749
04:43:30,378 --> 04:43:30,978
THE MANUFACTURING THEY CAN BE

5750
04:43:30,978 --> 04:43:33,214
MANUFACTURED IN DIFFERENT WAYS.

5751
04:43:33,214 --> 04:43:41,922
AND TO THE LEFT I HAVE MAN WHO

5752
04:43:41,922 --> 04:43:42,456
IS LOOKING OR HANDLING THE

5753
04:43:42,456 --> 04:43:45,926
PRODUCTS IN OPEN SETTING.

5754
04:43:45,926 --> 04:43:46,560
IF WE NEED A STERILE PRODUCT IT

5755
04:43:46,560 --> 04:43:51,799
DOESN'T WORK.

5756
04:43:51,799 --> 04:43:55,770
BECAUSE IN THIS CASE PATHOGENS

5757
04:43:55,770 --> 04:44:03,010
MIGHT COME OR BUGS COULD COME IN

5758
04:44:03,010 --> 04:44:03,611
CONTACT WITH THE PRODUCT ALSO

5759
04:44:03,611 --> 04:44:04,545
WATER COULD COME IN CONTACT AND

5760
04:44:04,545 --> 04:44:08,816
REMEMBER I SAID L. REUTERI WILL

5761
04:44:08,816 --> 04:44:09,450
DIE WITH WATER SO WE DON'T WANT

5762
04:44:09,450 --> 04:44:12,453
TO HAVE THIS OPEN HANDLING WE

5763
04:44:12,453 --> 04:44:16,857
WENT CLOSED HANDLING SO THEN WE

5764
04:44:16,857 --> 04:44:19,427
SEE THE GLOVEBOX AND THE PERSON

5765
04:44:19,427 --> 04:44:25,399
MANIPULATING SOMETHING BUT NOW

5766
04:44:25,399 --> 04:44:35,910
THE RULES SAY THAT IF YOU'RE

5767
04:44:35,910 --> 04:44:36,410
INTO STERILE INJECTABLE

5768
04:44:36,410 --> 04:44:37,011
MANUFACTURING YOU NEED TO SHOW

5769
04:44:37,011 --> 04:44:38,446
THE REGULATORS YOU ARE IN

5770
04:44:38,446 --> 04:44:42,516
CONTROL BUT THIS IS FREE FROM

5771
04:44:42,516 --> 04:44:48,422
BUGS AND THESE MANUFACTURERS

5772
04:44:48,422 --> 04:44:49,090
THEY PRACTICE EVERY DAY AND THEY

5773
04:44:49,090 --> 04:44:51,025
TRY TO STAY IN CONTROL OF THE

5774
04:44:51,025 --> 04:44:57,898
EQUIPMENT THEY HAVE TO BUT THEN

5775
04:44:57,898 --> 04:44:58,299
WE COME AND HELLO?

5776
04:44:58,299 --> 04:45:04,271
I HAVE A BUG I WOULD LIKE TO

5777
04:45:04,271 --> 04:45:04,839
BRING THAT INTO YOUR STERILE

5778
04:45:04,839 --> 04:45:05,139
ENVIRONMENT.

5779
04:45:05,139 --> 04:45:06,407
HOW DO YOU FEEL ABOUT THAT?

5780
04:45:06,407 --> 04:45:07,608
WHAT DO THEY SAY?

5781
04:45:07,608 --> 04:45:11,011
NO THANK YOU.

5782
04:45:11,011 --> 04:45:14,582
WILL YOU BUY A LOT?

5783
04:45:14,582 --> 04:45:15,216
YES I THINK I WILL ORDER SOME

5784
04:45:15,216 --> 04:45:19,854
MATERIAL I HOPE.

5785
04:45:19,854 --> 04:45:20,988
IS IT IS SO MUCH WORK FOR US AS

5786
04:45:20,988 --> 04:45:23,657
A COMPANY THAT I JUST WANT TO

5787
04:45:23,657 --> 04:45:33,434
TELL YOU THIS TODAY.

5788
04:45:33,434 --> 04:45:33,901
WHY ARE WE DOING THIS?

5789
04:45:33,901 --> 04:45:34,468
WHY DO WE GO THROUGH ALL OF

5790
04:45:34,468 --> 04:45:41,408
THESE CHALLENGES?

5791
04:45:41,408 --> 04:45:42,009
I THINK THE IMPORTANT THING TO

5792
04:45:42,009 --> 04:45:42,543
SAY IS WE DON'T NEED TO DO

5793
04:45:42,543 --> 04:45:42,743
THAT.

5794
04:45:42,743 --> 04:45:47,314
WE DO IT BECAUSE WE WANT TO

5795
04:45:47,314 --> 04:45:47,915
BECAUSE WE WANT TO HELP THE

5796
04:45:47,915 --> 04:45:48,516
BABIES THERE IS NO REGULATION

5797
04:45:48,516 --> 04:45:49,116
AND NOTHING FORCING US TO DO

5798
04:45:49,116 --> 04:45:50,451
WHAT WE ARE DOING.

5799
04:45:50,451 --> 04:45:52,520
WE DO THIS OUT OF FREE WELL.

5800
04:45:52,520 --> 04:45:59,560
AND WHAT WE WANT IS TO SEE

5801
04:45:59,560 --> 04:46:02,062
OURSELVES THAT IF YOU COMBINE A

5802
04:46:02,062 --> 04:46:03,864
PICTURE FROM DOCTOR PATEL'S

5803
04:46:03,864 --> 04:46:08,936
PUBLICATION AND YOU LOOK AT THE

5804
04:46:08,936 --> 04:46:09,537
EFFECTS ON THE MORTALITY AFTER

5805
04:46:09,537 --> 04:46:14,308
14 DAYS I CAN ALREADY SEE THE

5806
04:46:14,308 --> 04:46:16,010
BLUE AND THE RED ARE SEPARATED

5807
04:46:16,010 --> 04:46:20,181
AND THIS IS ALL MORTALITY AND

5808
04:46:20,181 --> 04:46:21,348
THIS MAKES US VERY HAPPY AND WE

5809
04:46:21,348 --> 04:46:27,488
ARE PROUD AND SAY THAT THIS IS A

5810
04:46:27,488 --> 04:46:28,055
WONDERFUL THING WE HAVE BEEN

5811
04:46:28,055 --> 04:46:30,157
WORKING WITH THE LAST 12 YEARS.

5812
04:46:30,157 --> 04:46:40,701
SO THE NEXT STEP IS TO PREPARE.

5813
04:46:42,837 --> 04:46:43,404
AND YOU CAN SEE TO THE LEFT THE

5814
04:46:43,404 --> 04:46:44,038
PICTURE IS OLD BUT THIS IS WHAT

5815
04:46:44,038 --> 04:46:44,672
IT LOOKS BACK HOME IN SWEDEN AS

5816
04:46:44,672 --> 04:46:45,539
WE GATHER THE REPORTS IN THE

5817
04:46:45,539 --> 04:46:56,083
DATA AND PUTTING THEM TOGETHER.

5818
04:46:59,320 --> 04:46:59,854
AFTER THAT HOPEFULLY FDA WILL

5819
04:46:59,854 --> 04:47:00,421
LOOK AND COME OUT AND SAY

5820
04:47:00,421 --> 04:47:03,891
SOMETHING POSITIVE.

5821
04:47:03,891 --> 04:47:05,526
THEN WE HAVE A PRODUCT WE CAN

5822
04:47:05,526 --> 04:47:08,596
GIVE.

5823
04:47:08,596 --> 04:47:09,029
I HAVE IT SOMEWHERE.

5824
04:47:09,029 --> 04:47:19,240
IT IS EMPTY.

5825
04:47:22,142 --> 04:47:22,710
BUT WE WANT TO GIVE THAT PRODUCT

5826
04:47:22,710 --> 04:47:23,344
TO PEOPLE WHO WERE LOOKING FOR

5827
04:47:23,344 --> 04:47:24,645
THE PRODUCT THIS IS A WHOLE

5828
04:47:24,645 --> 04:47:26,747
THING WE ARE DOING.

5829
04:47:26,747 --> 04:47:29,416
THIS IS WHY WE ARE DOING THE

5830
04:47:29,416 --> 04:47:34,321
TRIAL.

5831
04:47:34,321 --> 04:47:44,632
THANK YOU SO MUCH.

5832
04:48:06,787 --> 04:48:14,828
>> QUESTIONS?

5833
04:48:14,828 --> 04:48:25,306
>> FROM PEDIATRICS THIS IS
A

5834
04:48:31,745 --> 04:48:32,313
QUESTION FOR DOCTORS JOSEPH NEU

5835
04:48:32,313 --> 04:48:32,947
WE TALK ABOUT THINGS AND HAVING

5836
04:48:32,947 --> 04:48:33,447
STRICT PROTOCOL BUT AS A

5837
04:48:33,447 --> 04:48:34,014
CLINICIAN YOU ALSO KNOW THAT

5838
04:48:34,014 --> 04:48:34,615
EVERYTHING IS CONTEXTUAL FROM

5839
04:48:34,615 --> 04:48:35,249
PLACE TO PLACE TALK ABOUT PEOPLE

5840
04:48:35,249 --> 04:48:39,253
IN YOUR TRIAL BEING LOYAL TO

5841
04:48:39,253 --> 04:48:39,887
THEIR ALGORITHM AND WHEN I LOOK

5842
04:48:39,887 --> 04:48:40,487
AT THE CENTERS THAT HAVE GOOD

5843
04:48:40,487 --> 04:48:41,922
EXCELLENCE TAKING CARE OF THE

5844
04:48:41,922 --> 04:48:49,463
MOST PREMATURITY THE GERMANS AND

5845
04:48:49,463 --> 04:48:50,064
THE JAPANESE I HAVE EXTREMELY

5846
04:48:50,064 --> 04:48:50,497
DIFFERENT STRATEGIES

5847
04:48:50,497 --> 04:48:51,098
DIAMETRICALLY OPPOSED BUT YET

5848
04:48:51,098 --> 04:48:53,300
THEY ALL GET GOOD OUTCOMES.

5849
04:48:53,300 --> 04:48:54,468
SO AS SOMEBODY WHO IS A TRIAL

5850
04:48:54,468 --> 04:49:01,342
LIST ALSO, THIS JUST SEEMS LIKE

5851
04:49:01,342 --> 04:49:01,942
A COMPLICATED THING BECAUSE WE

5852
04:49:01,942 --> 04:49:02,509
KEEP COMING DOWN TO THE VERY

5853
04:49:02,509 --> 04:49:03,110
NARROW DISEASES BUT LIVE IN A

5854
04:49:03,110 --> 04:49:13,654
COMPLICATED WORLD JUGGLING MANY

5855
04:49:14,221 --> 04:49:14,688
BALLS OF RISK AND HOW YOU

5856
04:49:14,688 --> 04:49:15,289
ACCOUNT FOR THAT IN THE TRIALS

5857
04:49:15,289 --> 04:49:15,923
WERE CONTEXT MATTERS EVEN WITH A

5858
04:49:15,923 --> 04:49:16,490
PRODUCT THAT IS PROVEN TO BE

5859
04:49:16,490 --> 04:49:26,934
EFFICACIOUS IN A SETTING.

5860
04:49:29,236 --> 04:49:29,803
>> I 100 PERCENT AGREE IT
HAS TO

5861
04:49:29,803 --> 04:49:30,404
BE CONTEXTUALIZED AND JUST TO

5862
04:49:30,404 --> 04:49:31,005
GIVE YOU AN EXAMPLE, WHEN YOU

5863
04:49:31,005 --> 04:49:31,605
LOOK AT THE SUSTAINED FEEDING

5864
04:49:31,605 --> 04:49:35,909
TOLERANCE AND COMPARE EUROPE TO

5865
04:49:35,909 --> 04:49:36,477
THE UNITED STATES AND IN THE

5866
04:49:36,477 --> 04:49:36,977
UNITED STATES THERE IS A

5867
04:49:36,977 --> 04:49:37,578
SIGNIFICANT DIFFERENCE AND IN

5868
04:49:37,578 --> 04:49:45,285
EUROPE THERE IS NOT BUT THE

5869
04:49:45,285 --> 04:49:45,819
PRODUCT VERSUS PLACEBO AND

5870
04:49:45,819 --> 04:49:46,120
EXACTLY WHY?

5871
04:49:46,120 --> 04:49:46,687
WE DON'T KNOW BUT THERE ARE

5872
04:49:46,687 --> 04:49:49,189
DIFFERENCES ACROSS THE POND WITH

5873
04:49:49,189 --> 04:49:49,656
PRACTICES TRADITIONAL

5874
04:49:49,656 --> 04:49:57,197
DIFFERENCES AND I THINK THAT

5875
04:49:57,197 --> 04:49:57,698
SOME OF THOSE INGRAINED

5876
04:49:57,698 --> 04:49:58,265
DIFFERENCES MAY BE A PART OF

5877
04:49:58,265 --> 04:49:58,465
THAT.

5878
04:49:58,465 --> 04:49:59,033
ABSOLUTELY I COULD NOT AGREE

5879
04:49:59,033 --> 04:50:08,809
MORE.

5880
04:50:08,809 --> 04:50:17,584
>> SO FROM THE RESUME A
QUESTION

5881
04:50:17,584 --> 04:50:18,118
DOES IT CAUSE MORTALITY A

5882
04:50:18,118 --> 04:50:18,852
DIFFERENT OPINION ON THE USE OR

5883
04:50:18,852 --> 04:50:22,222
EXCLUSIVE MOSTLY ON HUMAN MILK

5884
04:50:22,222 --> 04:50:29,596
VERSUS PRETERM FORMULA?

5885
04:50:29,596 --> 04:50:30,097
>> THAT'S A REALLY GOOD

5886
04:50:30,097 --> 04:50:30,364
QUESTION.

5887
04:50:30,364 --> 04:50:30,964
WE HAVE NOT DISSECTED THAT OUT

5888
04:50:30,964 --> 04:50:31,565
AND IT IS SOMETHING WE NEED TO

5889
04:50:31,565 --> 04:50:31,799
LOOK AT.

5890
04:50:31,799 --> 04:50:41,308
THANK YOU.

5891
04:50:41,308 --> 04:50:49,650
>> DOCTOR JOSEPH NEU WHAT
IS

5892
04:50:49,650 --> 04:50:51,018
YOUR RECOMMENDATION TO FDA AFTER

5893
04:50:51,018 --> 04:50:56,156
THIS TRIAL?

5894
04:50:56,156 --> 04:50:58,625
I READ THAT QUESTION BECAUSE I

5895
04:50:58,625 --> 04:51:00,260
ASSUMED IT WAS THE OUTCOME FROM

5896
04:51:00,260 --> 04:51:02,696
HIS PREVIOUS TALK.

5897
04:51:02,696 --> 04:51:10,771
>> IT IS NOT UP TO ME TO
DECIDE.

5898
04:51:10,771 --> 04:51:17,277
>> JUST QUICKLY TO TOUCH
ON THE

5899
04:51:17,277 --> 04:51:27,621
QUESTION OF FORMULA.

5900
04:51:31,525 --> 04:51:32,092
>> SO THIS IS SOMETHING ME
HAVE

5901
04:51:32,092 --> 04:51:32,726
A VERY RICH DATA SET AND AT THIS

5902
04:51:32,726 --> 04:51:33,360
JUNCTURE THERE IS SO MANY THINGS

5903
04:51:33,360 --> 04:51:33,927
WE STILL NEED TO DISSECT AND

5904
04:51:33,927 --> 04:51:36,497
THAT IS 1 OF THEM.

5905
04:51:36,497 --> 04:51:37,431
THE TYPE OF FEEDING THAT THESE

5906
04:51:37,431 --> 04:51:41,735
BABIES HAVE RECEIVED.

5907
04:51:41,735 --> 04:51:52,279
>> YOU ARE A DOCTOR SO
WHERE DO

5908
04:52:00,454 --> 04:52:00,821
YOU END UP ON THIS?

5909
04:52:00,821 --> 04:52:01,355
>> IT'S A GOOD QUESTION.

5910
04:52:01,355 --> 04:52:01,955
WE ARE PRODUCING IT IN EUROPE

5911
04:52:01,955 --> 04:52:02,523
AND THE REASON IS BECAUSE WE

5912
04:52:02,523 --> 04:52:03,090
HAVE TO STAY VERY CLOSE TO

5913
04:52:03,090 --> 04:52:03,690
MANUFACTURERS AND SINCE WE ARE

5914
04:52:03,690 --> 04:52:04,224
BASED IN EUROPE WE HAVE

5915
04:52:04,224 --> 04:52:07,961
MANUFACTURING IN EUROPE.

5916
04:52:07,961 --> 04:52:09,029
>> WAS IT IN A TRADITIONAL
SMALL

5917
04:52:09,029 --> 04:52:10,664
MOLECULE MANUFACTURER?

5918
04:52:10,664 --> 04:52:17,004
CAN YOU SAY MORE ABOUT THAT?

5919
04:52:17,004 --> 04:52:17,538
>> I CAN'T SPEAK ABOUT IT

5920
04:52:17,538 --> 04:52:18,071
BECAUSE IT COMES FROM THE

5921
04:52:18,071 --> 04:52:24,211
DIETARY SUPPLEMENT COMPANY AND I

5922
04:52:24,211 --> 04:52:24,711
WAS VISITING THE CURRENT

5923
04:52:24,711 --> 04:52:26,847
PRODUCERS AND SINCE I AM NEXT

5924
04:52:26,847 --> 04:52:28,148
REGULATOR AND WORKING WITH THE

5925
04:52:28,148 --> 04:52:30,684
LARGE COMPANIES I FELT THAT IT

5926
04:52:30,684 --> 04:52:33,654
WAS RIGHT FROM THE BEGINNING AND

5927
04:52:33,654 --> 04:52:41,795
I DO NOT USE ANY LBL

5928
04:52:41,795 --> 04:52:42,396
MANUFACTURERS AND HAD TO START

5929
04:52:42,396 --> 04:52:42,963
FROM SCRATCH AND PEOPLE THAT

5930
04:52:42,963 --> 04:52:43,564
WERE DOING PHARMACEUTICALS NOT

5931
04:52:43,564 --> 04:52:49,336
DOING FOOD PRODUCTS.

5932
04:52:49,336 --> 04:52:49,937
A VERY HIGH COST I MUST SAY TO

5933
04:52:49,937 --> 04:53:00,180
DO THE SWITCH.

5934
04:53:18,932 --> 04:53:19,933
>> CAN YOU PLEASE REPEAT
THE

5935
04:53:19,933 --> 04:53:20,200
QUESTION?

5936
04:53:20,200 --> 04:53:30,744
>> TALK ABOUT L. REUTERI
AND TO

5937
04:53:34,948 --> 04:53:35,482
GIVE THAT AS A MOLECULE TO THE

5938
04:53:35,482 --> 04:53:35,983
BABIES IS THE QUESTION.

5939
04:53:35,983 --> 04:53:36,617
WE THOUGHT YOU COULD DO THIS BUT

5940
04:53:36,617 --> 04:53:37,351
WHY CHANGE THE SYSTEM THAT COMES

5941
04:53:37,351 --> 04:53:41,622
FROM MOTHERS?

5942
04:53:41,622 --> 04:53:42,756
WE HAVE SOURCED THE STRAIN FROM

5943
04:53:42,756 --> 04:53:53,300
LACTATING WOMEN IN HUMANS AND SO

5944
04:53:56,003 --> 04:53:56,603
THEREFORE WE HAVE TAKEN FROM THE

5945
04:53:56,603 --> 04:53:57,237
BREAST MILK THAT'S WHAT WE ARE

5946
04:53:57,237 --> 04:53:57,804
GROWING IN THE FACTORY SO WE

5947
04:53:57,804 --> 04:53:58,305
THOUGHT EVERYBODY LIKES

5948
04:53:58,305 --> 04:53:58,905
BREASTMILK IT IS PROBABLY VERY

5949
04:53:58,905 --> 04:53:59,539
SAFE TO GIVE SOMETHING THAT THEY

5950
04:53:59,539 --> 04:54:00,841
NORMALLY GET WERE NOT SAYING

5951
04:54:00,841 --> 04:54:01,408
THAT'S THE REASON TO GET IT

5952
04:54:01,408 --> 04:54:02,342
APPROVED BUT IT IS A GOOD

5953
04:54:02,342 --> 04:54:09,283
STARTING POINT.

5954
04:54:09,283 --> 04:54:16,556
>> WHAT IS IT?

5955
04:54:16,556 --> 04:54:26,500
>> SO THERE IS A QUESTION
AND A

5956
04:54:26,500 --> 04:54:27,034
HAS TO DO WITH THE WAY THE

5957
04:54:27,034 --> 04:54:28,969
ANALYSIS IS DONE WITH THE MODERN

5958
04:54:28,969 --> 04:54:34,574
TREATMENT WITH THE DOUBLE-BLIND

5959
04:54:34,574 --> 04:54:35,075
FOR ALL CAUSE MORTALITY.

5960
04:54:35,075 --> 04:54:40,147
>> SO THE MODIFICATION
LARGELY

5961
04:54:40,147 --> 04:54:41,715
WAS IN DISCUSSION WITH THE

5962
04:54:41,715 --> 04:54:52,159
STATISTICIAN AND IF YOU DO

5963
04:54:52,626 --> 04:54:53,193
STRAIGHT INTENTION TO TREAT AND

5964
04:54:53,193 --> 04:54:53,794
IF YOU HAVE ABSOLUTELY NO DRUG

5965
04:54:53,794 --> 04:55:02,369
BEING GIVEN TO THE INDIVIDUAL IT

5966
04:55:02,369 --> 04:55:02,903
JUST DOESN'T MAKE SENSE TO

5967
04:55:02,903 --> 04:55:03,236
INCLUDE THAT.

5968
04:55:03,236 --> 04:55:03,804
SO I THINK IT MADE A LOT OF

5969
04:55:03,804 --> 04:55:04,938
SENSE TO HAVE THAT MODIFICATION

5970
04:55:04,938 --> 04:55:07,174
WHERE IN THE DRUG GROUP AT LEAST

5971
04:55:07,174 --> 04:55:10,844
THEY HAVE RECEIVED 1 DOSE OF THE

5972
04:55:10,844 --> 04:55:20,954
DRUG.

5973
04:55:22,589 --> 04:55:23,156
>> FOLLOWING UP ON A
PREVIOUS

5974
04:55:23,156 --> 04:55:23,757
QUESTION CAN YOU TALK MORE HOW

5975
04:55:23,757 --> 04:55:24,257
THE MANUFACTURING OF THE

5976
04:55:24,257 --> 04:55:25,926
PHARMACEUTICAL LEVEL PRODUCT

5977
04:55:25,926 --> 04:55:28,495
DIFFERS FROM THE FOOD GRADE

5978
04:55:28,495 --> 04:55:31,031
PRODUCT?

5979
04:55:31,031 --> 04:55:33,433
>> IT IS A GOOD QUESTION.

5980
04:55:33,433 --> 04:55:36,303
HOW MUCH YOU KNOW ABOUT

5981
04:55:36,303 --> 04:55:38,505
PHARMACOPEIA?

5982
04:55:38,505 --> 04:55:39,072
>> THE PACKET WE USE IN
MED

5983
04:55:39,072 --> 04:55:40,140
SCHOOL?

5984
04:55:40,140 --> 04:55:46,847
[LAUGHTER]

5985
04:55:46,847 --> 04:55:56,490
>> IT IS A VERY LONG
ANSWER.

5986
04:55:56,490 --> 04:55:57,157
I DON'T KNOW WHERE TO START BUT

5987
04:55:57,157 --> 04:55:57,758
FOR EXAMPLE EVERY BATCH SHOULD

5988
04:55:57,758 --> 04:55:59,359
BE TESTED SO YOU DON'T HAVE

5989
04:55:59,359 --> 04:56:01,962
PATHOGENS DO YOU SEE THAT

5990
04:56:01,962 --> 04:56:03,196
GLOVEBOX I WAS SHOWING?

5991
04:56:03,196 --> 04:56:10,537
WHAT HAPPENS IF THERE WAS A

5992
04:56:10,537 --> 04:56:11,138
LEAKAGE OR SOMEBODY HAS A LONG

5993
04:56:11,138 --> 04:56:11,671
FINGERNAIL AND THERE IS A

5994
04:56:11,671 --> 04:56:11,872
WHOLE?

5995
04:56:11,872 --> 04:56:13,673
WE WANT TO DETECT THAT ERROR

5996
04:56:13,673 --> 04:56:16,176
PRIOR TO GIVING YOU THEIR

5997
04:56:16,176 --> 04:56:20,013
PRODUCTS WITH THE UNDOCUMENTED

5998
04:56:20,013 --> 04:56:20,213
RISK.

5999
04:56:20,213 --> 04:56:27,287
SO WE WILL TEST EVERY BATCH AND

6000
04:56:27,287 --> 04:56:27,654
LOOK FOR ERRORS.

6001
04:56:27,654 --> 04:56:28,288
>> DOES THAT TESTING NOT
HAPPEN

6002
04:56:28,288 --> 04:56:34,294
WITH FOOD SUPPLEMENTS?

6003
04:56:34,294 --> 04:56:34,828
>> I DON'T WORK IN FOOD

6004
04:56:34,828 --> 04:56:35,128
SUPPLEMENTS.

6005
04:56:35,128 --> 04:56:41,401
AND I KNOW FROM THE COST REASON

6006
04:56:41,401 --> 04:56:42,002
THEY CANNOT APPLY THE THINGS

6007
04:56:42,002 --> 04:56:42,335
THAT WE APPLY.

6008
04:56:42,335 --> 04:56:43,270
THAT IS THE POLITICALLY CORRECT

6009
04:56:43,270 --> 04:56:53,547
ANSWER I THINK.

6010
04:56:53,914 --> 04:56:54,481
>> I WILL PUT YOU ON THE
SPOT TO

6011
04:56:54,481 --> 04:56:54,815
DOVETAIL THAT.

6012
04:56:54,815 --> 04:56:55,382
IF IBT PRODUCT IS EVENTUALLY

6013
04:56:55,382 --> 04:56:56,750
APPROVED IN THE US IS THERE AN

6014
04:56:56,750 --> 04:56:57,717
ESTIMATED PRICE POINT COMPARED

6015
04:56:57,717 --> 04:57:08,228
TO THE PRODUCTS FOR USE QUICK.

6016
04:57:14,601 --> 04:57:15,068
>> LOOKING AT THE COST OF

6017
04:57:15,068 --> 04:57:15,669
PRODUCTION IS MUCH HIGHER BUT

6018
04:57:15,669 --> 04:57:16,203
THAT IS 1 PIECE INVESTING

6019
04:57:16,203 --> 04:57:16,803
$110 MILLION IN A DEVELOPMENT

6020
04:57:16,803 --> 04:57:17,437
PROGRAM IS 1 PIECE AND VERY MUCH

6021
04:57:17,437 --> 04:57:17,871
ABOUT THE EFFICACY.

6022
04:57:17,871 --> 04:57:20,307
IF WE SAY THIS HAS NO EFFECT AND

6023
04:57:20,307 --> 04:57:24,678
THE COST OF THE PRICE WILL BE 0

6024
04:57:24,678 --> 04:57:25,278
AND IT'S OKAY IF I DON'T SAY

6025
04:57:25,278 --> 04:57:29,249
ANYTHING BUT IF I WANT TO SAY TO

6026
04:57:29,249 --> 04:57:31,918
PREVENT DEATH OR SOMETHING THEN

6027
04:57:31,918 --> 04:57:41,561
IT BECOMES A DRUG THAT WE HAVE

6028
04:57:41,561 --> 04:57:42,162
LABELED CLAIMS WITH THE FDA IN

6029
04:57:42,162 --> 04:57:42,796
THE COUNTRY AND LET'S SEE WHERE

6030
04:57:42,796 --> 04:57:43,029
IT LAST.

6031
04:57:43,029 --> 04:57:43,563
AFTER THAT WE CAN DISCUSS

6032
04:57:43,563 --> 04:57:52,405
PRICE.

6033
04:57:52,405 --> 04:57:53,006
>> WE HAVE JUST A COUPLE
OF

6034
04:57:53,006 --> 04:57:53,340
SECONDS LEFT.

6035
04:57:53,340 --> 04:57:59,446
THANK YOU FOR THE PRESENTATION

6036
04:57:59,446 --> 04:58:00,013
THANK YOU FOR PARTICIPATING.

6037
04:58:00,013 --> 04:58:00,547
WE HAVE 1 MORE SECTION AND

6038
04:58:00,547 --> 04:58:03,116
CLOSING COMMENTS BUT I WANT TO

6039
04:58:03,116 --> 04:58:07,420
TAKE A MOMENT TO THANK THE TEAM

6040
04:58:07,420 --> 04:58:10,524
FOR PUTTING EVERYTHING TOGETHER

6041
04:58:10,524 --> 04:58:15,061
OBVIOUSLY IT'S VERY IMPORTANT TO

6042
04:58:15,061 --> 04:58:18,698
HAVE EVERYBODY'S INPUT ALSO

6043
04:58:18,698 --> 04:58:20,700
THANK YOU TO ALL THE NIAID FOLKS

6044
04:58:20,700 --> 04:58:26,339
AS WELL AS THE SUPPORT FROM MY

6045
04:58:26,339 --> 04:58:26,873
BRANCH AND SECTION CHIEF.

6046
04:58:26,873 --> 04:58:30,777
LUSCIOUS WHAT I WANTED TO DO BUT

6047
04:58:30,777 --> 04:58:33,280
THEN ASKS SECTION IS A CLOSING

6048
04:58:33,280 --> 04:58:40,186
REMARKS.

6049
04:58:40,186 --> 04:58:40,787
HE WILL BE SENT OFF WITH SOME

6050
04:58:40,787 --> 04:58:41,021
WISDOM.

6051
04:58:41,021 --> 04:58:41,488
HE HAS A LOT OF NOTES.

6052
04:58:41,488 --> 04:58:43,256
I SAW HIM TYPING.

6053
04:58:43,256 --> 04:58:53,700
>> SO MY ASSIGNMENT IS TO

6054
04:58:54,935 --> 04:58:55,368
ATTEMPT A BRIEF SUMMARY

6055
04:58:55,368 --> 04:58:57,270
RECOGNIZING I AM BETWEEN YOU AND

6056
04:58:57,270 --> 04:59:01,942
FRIDAY RUSH HOUR ON THE CAPITAL

6057
04:59:01,942 --> 04:59:02,175
BELTWAY.

6058
04:59:02,175 --> 04:59:02,742
I WILL TRY TO KEEP IT SHORT.

6059
04:59:02,742 --> 04:59:06,546
HOPEFULLY FOUND THE PUBLIC -- --

6060
04:59:06,546 --> 04:59:07,147
THE OPEN PUBLIC WORKSHOP TODAY

6061
04:59:07,147 --> 04:59:08,214
ON THE CURRENT STATE OF

6062
04:59:08,214 --> 04:59:10,517
EPIDEMIOLOGY, NUTRITIONAL

6063
04:59:10,517 --> 04:59:17,123
ASPECTS OF NEC AND USE OF LBP TO

6064
04:59:17,123 --> 04:59:20,260
PREVENT NEC ON THE CURRENT

6065
04:59:20,260 --> 04:59:22,896
LITERATURE AND CLINICAL DESIGNS

6066
04:59:22,896 --> 04:59:24,397
AND ON MANUFACTURING OF THESE

6067
04:59:24,397 --> 04:59:27,200
PRODUCTS.

6068
04:59:27,200 --> 04:59:37,711
WE MAY NOT BE LEAVING WITH ALL

6069
04:59:40,213 --> 04:59:40,780
OF THE QUESTIONS ANSWERED BUT I

6070
04:59:40,780 --> 04:59:41,314
DO THINK WE COLLECTED SOME

6071
04:59:41,314 --> 04:59:41,948
ADDITIONAL QUESTIONS TODAY THAT

6072
04:59:41,948 --> 04:59:52,492
WILL BE HELPFUL IN REVISING AND

6073
04:59:48,359 --> 04:59:48,892
REFINING THE STRATEGIC ATTEMPT

6074
04:59:48,892 --> 04:59:49,526
OF WHAT WE ARE TRYING TO DO BUT

6075
04:59:49,526 --> 04:59:50,160
ALSO THE PROBLEM STATEMENT SO ON

6076
04:59:50,160 --> 04:59:50,794
THE NEXT COUPLE OF SLIDES I WILL

6077
04:59:50,794 --> 04:59:51,395
GO BACK TO A SLIDE PRESENTED

6078
04:59:51,395 --> 04:59:52,029
DURING THE INTRODUCTION AND TRY

6079
04:59:52,029 --> 04:59:52,496
TO CAPTURE SOME OF THE

6080
04:59:52,496 --> 04:59:53,097
ADDITIONAL QUESTIONS THAT MAY

6081
04:59:53,097 --> 04:59:53,731
HAVE COME OUT OF THE DISCUSSION

6082
04:59:53,731 --> 04:59:53,931
TODAY.

6083
04:59:53,931 --> 04:59:54,531
SO ON THE FIRST SLIDE THIS HAS

6084
04:59:54,531 --> 04:59:56,834
TO DO WITH BIOLOGICAL PRODUCTS

6085
04:59:56,834 --> 04:59:59,436
WITH THEY WERE TO MAKE THE

6086
04:59:59,436 --> 05:00:09,980
ASSERTION BUT 1 THING THAT CAME

6087
05:00:11,782 --> 05:00:12,216
UP IN DISCUSSION THAT IS

6088
05:00:12,216 --> 05:00:12,850
CRITICALLY IMPORTANT IS WHAT IS

6089
05:00:12,850 --> 05:00:13,350
THE RECOGNIZE DISEASE OR

6090
05:00:13,350 --> 05:00:16,153
CONDITION THAT WE ARE ASSUMING

6091
05:00:16,153 --> 05:00:16,654
THIS PRODUCT ADDRESSES?

6092
05:00:16,654 --> 05:00:22,426
DO WE NEED TO TAKE A LOOK AT

6093
05:00:22,426 --> 05:00:23,060
NECROTIZING ENTEROCOLITIS AS A

6094
05:00:23,060 --> 05:00:23,661
RECOGNIZE DISEASE OR CONDITION

6095
05:00:23,661 --> 05:00:24,428
AND IS THERE SOMETHING ELSE THAT

6096
05:00:24,428 --> 05:00:28,298
SHOULD BE DEFINED?

6097
05:00:28,298 --> 05:00:30,868
I WILL LEAVE THAT AS AN OPEN

6098
05:00:30,868 --> 05:00:40,110
QUESTION.

6099
05:00:40,110 --> 05:00:40,778
SO WHERE DO WE LAND TODAY WITH

6100
05:00:40,778 --> 05:00:41,345
RESPECT TO ADEQUATE CLINICAL

6101
05:00:41,345 --> 05:00:41,879
INVESTIGATION TO ESTABLISH

6102
05:00:41,879 --> 05:00:42,479
SAFETY AND EFFECTIVENESS TO ME

6103
05:00:42,479 --> 05:00:48,585
STATUTORY REQUIREMENTS?

6104
05:00:48,585 --> 05:00:49,219
AND I THINK THERE WAS A PRETTY

6105
05:00:49,219 --> 05:00:49,853
LONG LIST OF QUESTIONS THAT CAME

6106
05:00:49,853 --> 05:00:50,421
UP FOR EXAMPLE THE ROLE FOR

6107
05:00:50,421 --> 05:00:55,359
PROPOSED RISK FACTORS WITH THE

6108
05:00:55,359 --> 05:00:55,926
STRATIFICATION AND SUBGROUP

6109
05:00:55,926 --> 05:00:57,861
ANALYSIS AND STANDARDS OF

6110
05:00:57,861 --> 05:01:00,464
STEWARDSHIP IN THE CLINICAL

6111
05:01:00,464 --> 05:01:03,167
TRIALS DO WE NEED STOOL

6112
05:01:03,167 --> 05:01:07,604
BIOMARKERS LIKE THE MICROBIAL

6113
05:01:07,604 --> 05:01:08,138
COMMUNITY PROFILES IN THE

6114
05:01:08,138 --> 05:01:14,712
CLINICAL INVESTIGATIONS?

6115
05:01:14,712 --> 05:01:15,312
>> 1 OF THE THINGS POINTED
OUT

6116
05:01:15,312 --> 05:01:16,413
GIVEN THE POTENTIAL FOR

6117
05:01:16,413 --> 05:01:19,283
CROSS-CONTAMINATION DO WE NEED

6118
05:01:19,283 --> 05:01:21,385
TO LOOK AT ALTERNATIVE CLINICAL

6119
05:01:21,385 --> 05:01:30,794
DESIGNS AND WHAT WORK DO WE HAVE

6120
05:01:30,794 --> 05:01:31,395
TO DO ON DEFINING STANDARD OF

6121
05:01:31,395 --> 05:01:31,995
CARE INCLUDING MEDICATIONS OF

6122
05:01:31,995 --> 05:01:36,667
BOTH OF THE CONTROL GROUP AND

6123
05:01:36,667 --> 05:01:37,334
THE INVESTIGATIONAL GROUP DURING

6124
05:01:37,334 --> 05:01:38,736
THE TRIAL IS THERE A NEED FOR

6125
05:01:38,736 --> 05:01:42,172
ACCEPTED CASE DEFINITIONS AS

6126
05:01:42,172 --> 05:01:44,641
WELL AS ADDITIONAL WORK ON THE

6127
05:01:44,641 --> 05:01:51,548
MECHANISTIC UNDERSTANDING OF

6128
05:01:51,548 --> 05:01:52,182
WHAT IS CAUSING THE DISEASE AND

6129
05:01:52,182 --> 05:01:52,716
THE CONDITION AND WHAT MAY

6130
05:01:52,716 --> 05:01:56,019
ACCOUNT FOR THE ABILITY THAT HAS

6131
05:01:56,019 --> 05:02:00,057
BEEN OBSERVED IN THOSE DISEASE

6132
05:02:00,057 --> 05:02:04,428
STATES AND CONDITIONS?

6133
05:02:04,428 --> 05:02:04,995
AND THAT IS A LONG LIST OF

6134
05:02:04,995 --> 05:02:06,130
QUESTIONS BUT WHAT ARE THE

6135
05:02:06,130 --> 05:02:10,434
IMPLICATIONS ON BOTH THE DESIGN

6136
05:02:10,434 --> 05:02:14,204
AND FEASIBILITY?

6137
05:02:14,204 --> 05:02:20,511
AND FINALLY THE NEED FOR

6138
05:02:20,511 --> 05:02:23,614
COMPLETION FOR A SPECIFIC

6139
05:02:23,614 --> 05:02:30,154
ADVERSE EVENT DEFINITION AND

6140
05:02:30,154 --> 05:02:30,754
RELATED TO THE SAFETY RISK AND

6141
05:02:30,754 --> 05:02:34,324
HARM AND THE USE OF ADJUDICATION

6142
05:02:34,324 --> 05:02:37,895
WITH CLINICAL INVESTIGATION.

6143
05:02:37,895 --> 05:02:40,164
FINALLY WHERE DO YOU LAND IN

6144
05:02:40,164 --> 05:02:44,001
TERMS OF MANUFACTURING?

6145
05:02:44,001 --> 05:02:44,501
HIGHLIGHTING SOME OF THE

6146
05:02:44,501 --> 05:02:46,303
PRODUCTION CHALLENGES 1 OF WHICH

6147
05:02:46,303 --> 05:02:51,375
IS INCLUDING AND ENSURING

6148
05:02:51,375 --> 05:02:51,975
RELIABILITY OF ALL THE THINGS

6149
05:02:51,975 --> 05:02:54,178
THAT IT COULD BE EXPOSED TO WHEN

6150
05:02:54,178 --> 05:03:00,184
IT LEAVES THE FACTORY FLOOR AND

6151
05:03:00,184 --> 05:03:00,851
GETS TO THE INFANT IN THE NICU.

6152
05:03:00,851 --> 05:03:01,451
A COUPLE OF OTHER THINGS THAT

6153
05:03:01,451 --> 05:03:05,823
CAME UP RELATED TO THE PRODUCT

6154
05:03:05,823 --> 05:03:10,194
AS PART OF THE INVESTIGATION

6155
05:03:10,194 --> 05:03:11,895
WOULD BE REALLY HELPFUL TO HAVE

6156
05:03:11,895 --> 05:03:17,568
A CLEAR DEFINITION OF WHAT IS

6157
05:03:17,568 --> 05:03:18,936
THE COMPOSITION TO FACILITATE

6158
05:03:18,936 --> 05:03:20,037
CLINICAL INVESTIGATIONS AND THEN

6159
05:03:20,037 --> 05:03:22,673
ALSO HOW DO WE CHARACTERIZE WHAT

6160
05:03:22,673 --> 05:03:25,876
ACTUALLY HAPPENS TO A PRODUCT

6161
05:03:25,876 --> 05:03:28,078
DURING THE CLINICAL

6162
05:03:28,078 --> 05:03:38,322
INVESTIGATION?

6163
05:03:38,889 --> 05:03:39,389
I WILL AND THERE I WILL ECHO

6164
05:03:39,389 --> 05:03:39,923
AGAIN A HUGE THANKS TO THE

6165
05:03:39,923 --> 05:03:40,457
SPEAKERS AND PRESENTERS IN

6166
05:03:40,457 --> 05:03:41,058
PERSON PARTICIPANTS AND THOSE

6167
05:03:41,058 --> 05:03:41,992
ONLINE PARTICULARLY MY

6168
05:03:41,992 --> 05:03:48,999
COLLEAGUES AT CDC AND NIH I WILL

6169
05:03:48,999 --> 05:03:49,533
MISS THE MONDAY AFTERNOON

6170
05:03:49,533 --> 05:03:49,800
MEETINGS.

6171
05:03:49,800 --> 05:03:50,100
I WILL END.

6172
05:03:50,100 --> 05:03:51,435
THANK YOU.

6173
05:03:51,435 --> 05:04:01,612
[APPLAUSE]