1 00:00:07,158 --> 00:00:07,925 >> GOOD MORNING, EVERYONE. 2 00:00:07,925 --> 00:00:10,261 WELCOME BACK TO DAY TWO OF THE 3 00:00:10,261 --> 00:00:12,129 186TH MEETING OF THE NICHD 4 00:00:12,129 --> 00:00:12,530 ADVISORY COUNCIL. 5 00:00:12,530 --> 00:00:14,165 I DID WANT TO POINT OUT 6 00:00:14,165 --> 00:00:15,666 SOMETHING ABOUT THE MICROPHONES. 7 00:00:15,666 --> 00:00:17,068 THESE MICROPHONES ARE DIFFERENT 8 00:00:17,068 --> 00:00:18,803 FROM THE ONES WE WERE USING 9 00:00:18,803 --> 00:00:20,204 YESTERDAY, SO NOW YOU WANT TO 10 00:00:20,204 --> 00:00:22,373 SEE THE GREEN SIGNAL IF YOU'RE 11 00:00:22,373 --> 00:00:23,941 SPEAKING, AND THEN TURN IT OFF 12 00:00:23,941 --> 00:00:27,278 AFTER YOU'RE DONE. 13 00:00:27,278 --> 00:00:28,779 TODAY WE'RE GOING TO HEAR A VERY 14 00:00:28,779 --> 00:00:30,047 SPECIAL REPORT FROM A NEW 15 00:00:30,047 --> 00:00:32,283 COUNCIL WORKING GROUP THAT WAS 16 00:00:32,283 --> 00:00:34,118 FORMED RECENTLY, VERY RECENTLY, 17 00:00:34,118 --> 00:00:39,023 IN FACT, IN AUGUST, ON 18 00:00:39,023 --> 00:00:42,693 NECROTIZING ENTEROCOLITIS, ALSO 19 00:00:42,693 --> 00:00:48,899 KNOWN AS INEQU NEC IN PREMATURE 20 00:00:48,899 --> 00:00:49,133 INFANTS. 21 00:00:49,133 --> 00:00:50,334 WE ESTABLISHED THIS GROUP LAST 22 00:00:50,334 --> 00:00:54,071 MONTH IN RESPONSE TO A UNITED 23 00:00:54,071 --> 00:00:54,705 STATES DEPARTMENT OF HEALTH AND 24 00:00:54,705 --> 00:00:55,239 HUMAN SERVICES REQUEST TO 25 00:00:55,239 --> 00:00:55,873 DEVELOP A SUMMARY OF THE STATE 26 00:00:55,873 --> 00:00:57,007 OF THE SCIENCE AND 27 00:00:57,007 --> 00:00:58,342 RECOMMENDATIONS FOR FUTURE AREAS 28 00:00:58,342 --> 00:00:59,076 OF RESEARCH. 29 00:00:59,076 --> 00:01:02,480 THE CO-CHAIRS, DR. YVONNE 30 00:01:02,480 --> 00:01:03,814 MALDONADO AND DR. RAVI PATEL 31 00:01:03,814 --> 00:01:07,084 WHO'S NOT A COUNCILMEMBER BUT A 32 00:01:07,084 --> 00:01:08,519 NEONATOLOGIST AS YOU'LL HEAR 33 00:01:08,519 --> 00:01:10,287 WILL PRESENT RESULTS OF THE 34 00:01:10,287 --> 00:01:11,355 GROUP'S INTENSIVE WORK OVER THE 35 00:01:11,355 --> 00:01:12,723 PAST SEVERAL WEEKS, AND WE'RE 36 00:01:12,723 --> 00:01:14,425 VERY GRATEFUL TO THEM AND TO THE 37 00:01:14,425 --> 00:01:16,961 NICHD STAFF AND ESPECIALLY TO 38 00:01:16,961 --> 00:01:19,430 OUR DEPUTY DIRECTOR, DR. ALISON 39 00:01:19,430 --> 00:01:20,431 CERNICH, WHO PULLED ALL THIS 40 00:01:20,431 --> 00:01:23,901 TOGETHER IN A VERY SHORT TIME. 41 00:01:23,901 --> 00:01:26,771 THE COUNCILMEMBERS KNOW 42 00:01:26,771 --> 00:01:31,809 DR. BONNIE MALD MALDONADO WHO S 43 00:01:31,809 --> 00:01:37,615 AS THE T OBY PROFESSOR OF GLOBAL 44 00:01:37,615 --> 00:01:40,651 HEALTH AND INFECTIOUS DISEASES, 45 00:01:40,651 --> 00:01:41,419 SENIOR ASSOCIATE DEAN, FACULTY 46 00:01:41,419 --> 00:01:43,154 DEVELOPMENT AND DIVERSITY, 47 00:01:43,154 --> 00:01:44,321 PROFESSOR OF PEDIATRICS AND 48 00:01:44,321 --> 00:01:45,589 INFECTIOUS DISEASES AND 49 00:01:45,589 --> 00:01:46,657 EPIDEMIOLOGY AND POPULATION 50 00:01:46,657 --> 00:01:49,326 HEALTH. 51 00:01:49,326 --> 00:01:50,628 DR. MALDONADO DIRECTS STANFORD'S 52 00:01:50,628 --> 00:01:51,695 GLOBAL CHILD HEALTH PROGRAM AND 53 00:01:51,695 --> 00:01:55,099 SERVES AS MEDICAL DIRECTOR OF 54 00:01:55,099 --> 00:01:56,767 INFECTION PREVENTION AND CONTROL 55 00:01:56,767 --> 00:01:59,804 AT THE LUCILE PACKARD CHILDREN'S 56 00:01:59,804 --> 00:02:00,438 HOSPITAL. 57 00:02:00,438 --> 00:02:02,206 SHE'S CURRENTLY SERVING AS 58 00:02:02,206 --> 00:02:03,107 THE -- SHE DOESN'T HAVE ENOUGH 59 00:02:03,107 --> 00:02:05,910 TO DO, SO NOW SHE'S CURRENTLY 60 00:02:05,910 --> 00:02:07,144 SERVING AS THE INTERIM CHAIR OF 61 00:02:07,144 --> 00:02:09,747 THE DEPARTMENT OF MEDICINE AND 62 00:02:09,747 --> 00:02:11,849 LEADS A RESEARCH PROGRAM ON 63 00:02:11,849 --> 00:02:14,151 EPIDEMIOLOGIC ASPECTS OF VIRAL 64 00:02:14,151 --> 00:02:15,953 VACCINE DEVELOPMENT AND 65 00:02:15,953 --> 00:02:17,855 PREVENTION OF PERINATAL HIV 66 00:02:17,855 --> 00:02:20,758 TRANSMISSION. 67 00:02:20,758 --> 00:02:22,760 ON VIDEO, WE'RE GRATEFUL 68 00:02:22,760 --> 00:02:24,428 DR. PATEL FOR YOU JOINING US, 69 00:02:24,428 --> 00:02:27,064 WE'VE GOT DR. RAVI PATEL, WHO'S 70 00:02:27,064 --> 00:02:28,466 A NEONATOLOGIST AT CHILDREN'S 71 00:02:28,466 --> 00:02:30,768 HEALTHCARE OF ATLANTA. 72 00:02:30,768 --> 00:02:33,771 HE'S PROFESSOR OF PEDIATRICS AT 73 00:02:33,771 --> 00:02:34,905 THE EMORY SCHOOL OF MEDICINE, 74 00:02:34,905 --> 00:02:36,540 WHERE HE DIRECTS A RESEARCH 75 00:02:36,540 --> 00:02:38,843 PROGRAM ON, NUMBER ONE, 76 00:02:38,843 --> 00:02:40,110 NECROTIZING ENTEROCOLITIS, 77 00:02:40,110 --> 00:02:42,580 INCLUDING ITS RELATIONSHIP WITH 78 00:02:42,580 --> 00:02:45,416 NEONATAL TRANSFUSION PRACTICES, 79 00:02:45,416 --> 00:02:46,717 NUMBER TWO, CAFFEINE THERAPY IN 80 00:02:46,717 --> 00:02:49,220 PRETERM INFANTS. 81 00:02:49,220 --> 00:02:50,554 DR. PATEL RECEIVED HIS 82 00:02:50,554 --> 00:02:52,122 MEDICAL DEGREE FROM MEDICAL 83 00:02:52,122 --> 00:02:54,158 COLLEGE OF GEORGIA AT AUGUSTA 84 00:02:54,158 --> 00:02:55,159 UNIVERSITY, FOLLOWED BY A 85 00:02:55,159 --> 00:02:58,429 MASTER'S OF SCIENCE IN CLINICAL 86 00:02:58,429 --> 00:03:00,531 RESEARCH AND FELLOWSHIP TRAINING 87 00:03:00,531 --> 00:03:02,733 IN NEONATOLOGY AT THE EMORY 88 00:03:02,733 --> 00:03:04,969 UNIVERSITY SCHOOL OF MEDICINE. 89 00:03:04,969 --> 00:03:06,637 SO THEY ARE GOING TO MAKE THEIR 90 00:03:06,637 --> 00:03:07,204 PRESENTATIONS. 91 00:03:07,204 --> 00:03:09,740 I'D ALSO LIKE TO ACKNOWLEDGE 92 00:03:09,740 --> 00:03:12,776 DAVID ROICH, MEMBER OF OUR 93 00:03:12,776 --> 00:03:14,178 ADVISORY COUNCIL, SERVED AS A 94 00:03:14,178 --> 00:03:15,579 MEMBER OF THIS WORKING GROUP. 95 00:03:15,579 --> 00:03:19,416 SO OVER TO DRS. MALDONADO AND 96 00:03:19,416 --> 00:03:20,951 PATEL, WHO MOVED MOUNTAINS IN A 97 00:03:20,951 --> 00:03:22,953 MATTER OF A FEW SHORT WEEKS, AND 98 00:03:22,953 --> 00:03:29,960 WE ARE VERY GRATEFUL TO YOU. 99 00:03:29,960 --> 00:03:30,895 >> THANK YOU, DIANE. 100 00:03:30,895 --> 00:03:38,335 I WANT TO THANK MY CO-CHAIR, DRN 101 00:03:38,335 --> 00:03:40,437 THIS AREA. 102 00:03:40,437 --> 00:03:50,614 SO AS YOU 103 00:03:59,890 --> 00:04:10,100 CAN YOU HEAR ME? 104 00:04:14,104 --> 00:04:16,407 SO I WANT TO THANK MYCO-CHAIR, 105 00:04:16,407 --> 00:04:26,684 DR. RA RAVI PATEL, AND ALSO WANY 106 00:04:26,684 --> 00:04:29,420 EXPEDITED AND PUT THIS PROGRAM 107 00:04:29,420 --> 00:04:31,922 TOGETHER VERY RAPIDLY, THEY DID 108 00:04:31,922 --> 00:04:33,624 A REALLY AMAZING JOB AT PULLING 109 00:04:33,624 --> 00:04:34,558 TOGETHER A LARGE GROUP OF 110 00:04:34,558 --> 00:04:35,759 SUBJECT MATTER EXPERTS AND 111 00:04:35,759 --> 00:04:36,961 YOU'LL SEE MORE ABOUT THAT. 112 00:04:36,961 --> 00:04:47,037 CAN YOU HEAR ME? 113 00:04:47,037 --> 00:04:47,938 IS THAT BETTER? 114 00:04:47,938 --> 00:04:48,305 >> YES. 115 00:04:48,305 --> 00:04:58,449 >> OKAY. 116 00:04:59,183 --> 00:05:01,018 >> AS YOU CAN SEE HERE, THE 117 00:05:01,018 --> 00:05:03,287 CHARGE -- IN AUGUST OF 2024, AT 118 00:05:03,287 --> 00:05:05,990 THE REQUEST OF THE SECRETARY OF 119 00:05:05,990 --> 00:05:06,557 THE DEPARTMENT OF HEALTH AND 120 00:05:06,557 --> 00:05:13,330 HUMAN SERVICES, NACHHD CONVENED 121 00:05:13,330 --> 00:05:15,833 A WORKING GROUP OF THE NATIONAL 122 00:05:15,833 --> 00:05:17,701 ADVISORY COUNCIL OF CHILD HEALTH 123 00:05:17,701 --> 00:05:22,606 AND HUMAN DEVELOPMENT. 124 00:05:22,606 --> 00:05:23,774 SO THE CHARGE -- THE SPECIFIC 125 00:05:23,774 --> 00:05:25,442 CHARGE TO THE WORKING GROUP 126 00:05:25,442 --> 00:05:27,311 INCLUDED THE FOLLOWING: WE WERE 127 00:05:27,311 --> 00:05:28,512 TO ASSESS THE SCIENTIFIC 128 00:05:28,512 --> 00:05:30,280 EVIDENCE REGARDING THE ENTERAL 129 00:05:30,280 --> 00:05:32,016 FEEDING PRACTICES IN PREMATURE 130 00:05:32,016 --> 00:05:33,984 INFANTS AND FACTORS THAT MAY 131 00:05:33,984 --> 00:05:36,387 PROTECT AGAINST OR INCREASE THE 132 00:05:36,387 --> 00:05:39,556 RISK FOR NECROTIZING 133 00:05:39,556 --> 00:05:40,157 ENTEROCOLITIS. 134 00:05:40,157 --> 00:05:41,692 WE WERE ASKED TO IDENTIFY 135 00:05:41,692 --> 00:05:42,726 IMPORTANT RESEARCH GAPS AND TO 136 00:05:42,726 --> 00:05:44,061 MAKE RECOMMENDATIONS FOR 137 00:05:44,061 --> 00:05:45,162 POTENTIAL FUTURE RESEARCH 138 00:05:45,162 --> 00:05:52,202 DIRECTIONS. 139 00:05:52,202 --> 00:05:53,704 NOW THE ACTUAL PROCESS ITSELF 140 00:05:53,704 --> 00:05:56,840 WAS FAIRLY RAPID BUT IT WAS 141 00:05:56,840 --> 00:05:57,608 QUITE THOROUGH CONSIDERING THE 142 00:05:57,608 --> 00:05:58,275 TIME FRAME. 143 00:05:58,275 --> 00:06:01,278 THE GROUP WAS COMPOSED OF 144 00:06:01,278 --> 00:06:03,981 SUBJECT MATTERS IN NECROTIZING 145 00:06:03,981 --> 00:06:06,050 ENTEROCOLITIS INCLUDING 146 00:06:06,050 --> 00:06:08,018 LABORATORY SCIENTISTS AND 147 00:06:08,018 --> 00:06:09,019 NEONATOLOGISTS, AS WELL AS 148 00:06:09,019 --> 00:06:09,887 ADVOCACY LEADERS. 149 00:06:09,887 --> 00:06:13,123 AS YOU CAN SEE HERE, THE GROUP 150 00:06:13,123 --> 00:06:15,225 MET THREE TIMES OVER THE LAST 151 00:06:15,225 --> 00:06:17,327 THREE WEEKS, ON AUGUST 15TH, 152 00:06:17,327 --> 00:06:19,463 22ND AND 28TH. 153 00:06:19,463 --> 00:06:21,365 AS PART OF THE STATE OF THE 154 00:06:21,365 --> 00:06:23,367 SCIENCE ANALYSIS, NICHD 155 00:06:23,367 --> 00:06:25,736 CONDUCTED AS WELL A PORTFOLIO 156 00:06:25,736 --> 00:06:28,238 REVIEW, AND YOU CAN SEE THERE 157 00:06:28,238 --> 00:06:30,174 FOR GRANTS ISSUED IN THE LAST 158 00:06:30,174 --> 00:06:34,178 FIVE YEARS FROM FISCAL YEAR 2018 159 00:06:34,178 --> 00:06:36,680 TO 2023, AND AS YOU CAN SEE, 160 00:06:36,680 --> 00:06:38,949 THEY IDENTIFIED OVER 161 00:06:38,949 --> 00:06:41,185 $101 MILLION IN NIH FUNDING 162 00:06:41,185 --> 00:06:42,653 RELATED TO NECROTIZING 163 00:06:42,653 --> 00:06:42,986 ENTEROCOLITIS. 164 00:06:42,986 --> 00:06:45,989 I'M GOING TO CALL IT NEC FOR NOW 165 00:06:45,989 --> 00:06:48,826 FORRESE OF SPEAKING. 166 00:06:48,826 --> 00:06:52,863 INCLUDING OVER 340 UNIQUE 167 00:06:52,863 --> 00:06:54,665 PROJECTS, 100 UNIQUE PIs AND 168 00:06:54,665 --> 00:06:57,234 60 UNIQUE INSTITUTIONS, WITH 44% 169 00:06:57,234 --> 00:06:58,902 OF THOSE FUNDS COMING FROM 170 00:06:58,902 --> 00:07:01,171 NICHD, INCLUDING CLINICAL 171 00:07:01,171 --> 00:07:03,474 TRIALS, 24% FROM NIDDK, 172 00:07:03,474 --> 00:07:06,410 INCLUDING MANY MECHANISTIC 173 00:07:06,410 --> 00:07:09,046 STUDIES, 40% OVERALL FOCUSED 174 00:07:09,046 --> 00:07:10,914 PRIMARILY ON NEC VERSUS NEC AS 175 00:07:10,914 --> 00:07:14,518 THE SECONDARY AIM OR OUT COME. 176 00:07:14,518 --> 00:07:16,086 ABOUT THREE QUARTERS INCLUDED 177 00:07:16,086 --> 00:07:17,354 RESEARCH PROJECT GRANTS, 10% 178 00:07:17,354 --> 00:07:20,958 WERE SBIR/STTRs AND 9% WERE 179 00:07:20,958 --> 00:07:29,500 COOPERATIVE AGREEMENTS. 180 00:07:29,500 --> 00:07:30,934 SO THE NEC WORKING GROUP 181 00:07:30,934 --> 00:07:31,935 ACTIVITIES INCLUDED THE 182 00:07:31,935 --> 00:07:32,569 FOLLOWING. 183 00:07:32,569 --> 00:07:34,438 WE REVIEWED THE STATE OF THE 184 00:07:34,438 --> 00:07:36,840 SCIENCE FOR RISK FACTORS FOR 185 00:07:36,840 --> 00:07:38,675 NEC, NUTRITIONAL SUPPORT FOR 186 00:07:38,675 --> 00:07:40,377 PRETERM INFANTS, AND 187 00:07:40,377 --> 00:07:41,311 ASSOCIATIONS BETWEEN FEEDING 188 00:07:41,311 --> 00:07:43,280 PRACTICES AND RISK OR SEVERITY 189 00:07:43,280 --> 00:07:44,148 OF NEC. 190 00:07:44,148 --> 00:07:45,249 WE THEN DEVELOPED 191 00:07:45,249 --> 00:07:46,517 RECOMMENDATIONS TO IMPROVE THE 192 00:07:46,517 --> 00:07:54,992 EVIDENCE BASE. 193 00:07:54,992 --> 00:07:57,694 SO AS MANY OF YOU MAY BE AWARE, 194 00:07:57,694 --> 00:07:58,796 NECROTIZING ENTEROCOLITIS IS A 195 00:07:58,796 --> 00:08:00,998 COMMON SERIOUS GASTROINTESTINAL 196 00:08:00,998 --> 00:08:02,299 ILLNESS IN WHICH THE TISSUE 197 00:08:02,299 --> 00:08:04,835 LINING IN THE INTESTINES BECOME 198 00:08:04,835 --> 00:08:06,804 INFLAMED, DIE, AND CAN SLOUGH 199 00:08:06,804 --> 00:08:07,571 OFF. 200 00:08:07,571 --> 00:08:08,972 SYMPTOMS INCLUDE BLOATING OR 201 00:08:08,972 --> 00:08:11,508 SWELLING OF THE ABDOMEN, BLOODY 202 00:08:11,508 --> 00:08:12,910 STOOL, BILE IN THE STOMACH AND 203 00:08:12,910 --> 00:08:14,344 FOOD NOT MOVING THROUGH THE 204 00:08:14,344 --> 00:08:15,112 INTESTINES. 205 00:08:15,112 --> 00:08:16,547 ONE OF THE LEADING CAUSES OF 206 00:08:16,547 --> 00:08:19,716 ILLNESS AND DEATH IN PRETERM 207 00:08:19,716 --> 00:08:21,451 INFANTS OCCURS PRIMARILY IN 208 00:08:21,451 --> 00:08:23,854 INFANTS BORN BEFORE 28 WEEKS 209 00:08:23,854 --> 00:08:26,056 GESTATIONAL AGE, WITH 1 INFANT 210 00:08:26,056 --> 00:08:26,990 DYING ALMOST EVERY DAY FROM NEC 211 00:08:26,990 --> 00:08:31,195 IN THE UNITED STATES, WITH 212 00:08:31,195 --> 00:08:31,962 APPROXIMATELY 356 DEATHS 213 00:08:31,962 --> 00:08:34,464 RECORDED IN 2022 ACCORDING TO 214 00:08:34,464 --> 00:08:36,099 CDC DATA. 215 00:08:36,099 --> 00:08:38,302 NEC CAN APPEAR SUDDENLY AT 216 00:08:38,302 --> 00:08:39,736 PROGRESS QUICKLY IN INFANTS WHO 217 00:08:39,736 --> 00:08:41,705 OTHERWISE MAY SEEM TO BE GETTING 218 00:08:41,705 --> 00:08:48,345 HEHEALTHIER. 219 00:08:48,345 --> 00:08:49,346 FACTORS THAT MAY BE ASSOCIATED 220 00:08:49,346 --> 00:08:54,051 WITH RISK FOR NEC INCLUDE 221 00:08:54,051 --> 00:08:57,421 MATERNAL/ANTENATAL FACTORS. 222 00:08:57,421 --> 00:08:59,756 FACTORS RELATED TO MOTHERS' 223 00:08:59,756 --> 00:09:01,158 PREGNANCY, HEALTH AND TREATMENT 224 00:09:01,158 --> 00:09:02,426 AND THE INFANTS' CHARACTERISTICS 225 00:09:02,426 --> 00:09:04,661 AND TREATMENT. 226 00:09:04,661 --> 00:09:06,730 FACTORS THAT APPEAR TO INCREASE 227 00:09:06,730 --> 00:09:08,565 RISK INCLUDE MATERNAL 228 00:09:08,565 --> 00:09:10,234 PREECLAMPSIA AND HYPERTENSION, 229 00:09:10,234 --> 00:09:12,536 AND VERY LOW BIRTH WEIGHT OR 230 00:09:12,536 --> 00:09:13,937 SMALL FOR GESTATIONAL AGE 231 00:09:13,937 --> 00:09:14,972 INFANTS. 232 00:09:14,972 --> 00:09:17,341 AND FACTORS THAT APPEAR TO BE 233 00:09:17,341 --> 00:09:20,344 PROTECTIVE INCLUDE MATERNAL 234 00:09:20,344 --> 00:09:24,781 ANTENATAL CORTICOSTEROID USE AND 235 00:09:24,781 --> 00:09:31,788 EXPOSURE TO HUMAN MILK. 236 00:09:31,788 --> 00:09:35,459 SO THE FOLLOWING ASSESSMENT IS 237 00:09:35,459 --> 00:09:37,060 OF THE QUALITY OF THE RESEARCH 238 00:09:37,060 --> 00:09:38,562 EVIDENCE AND DOES NOT REPRESENT 239 00:09:38,562 --> 00:09:40,564 CLINICAL GUIDANCE. 240 00:09:40,564 --> 00:09:42,499 PLEASE REFER TO PRACTICE 241 00:09:42,499 --> 00:09:44,167 ORGANIZATIONS FOR SPECIFIC 242 00:09:44,167 --> 00:09:44,801 CLINICAL MANAGEMENT 243 00:09:44,801 --> 00:09:45,969 RECOMMENDATIONS. 244 00:09:45,969 --> 00:09:49,306 AND AT THIS TIME, I'M GOING TO 245 00:09:49,306 --> 00:09:53,010 TURN OVER THE DISCUSSION TO MY 246 00:09:53,010 --> 00:09:53,877 CO-CHAIR, DR. RAVI PATEL. 247 00:09:53,877 --> 00:09:58,916 THANK YOU. 248 00:09:58,916 --> 00:10:01,184 >> THANK YOU, GOOD MORNING TO 249 00:10:01,184 --> 00:10:01,451 EVERYONE. 250 00:10:01,451 --> 00:10:02,619 WE'RE GOING TO START WITH SOME 251 00:10:02,619 --> 00:10:03,687 FOUNDATIONAL STARTING POINTS 252 00:10:03,687 --> 00:10:05,923 THAT THE WORKING GROUP BEGAN 253 00:10:05,923 --> 00:10:09,960 WITH, AND ACKNOWLEDGED THESE 254 00:10:09,960 --> 00:10:12,996 CONCEPTS THAT THEY MUST BE FED 255 00:10:12,996 --> 00:10:14,331 AS SOON AS MEDICALLY FEASIBLE, 256 00:10:14,331 --> 00:10:20,337 AND THAT NUTRITION IS VITAL FOR 257 00:10:20,337 --> 00:10:22,572 THEIR BRAIN AND FEEDING SHOULD 258 00:10:22,572 --> 00:10:24,174 BE DONE BY WHATEVER MEANS IS 259 00:10:24,174 --> 00:10:25,809 AVAILABLE. 260 00:10:25,809 --> 00:10:28,111 HOWEVER, INTRAVENOUS FEEDING CAN 261 00:10:28,111 --> 00:10:29,780 INCREASE THE RISK OF DEVELOPING 262 00:10:29,780 --> 00:10:30,747 BLOODSTREAM INFORECASTS. 263 00:10:30,747 --> 00:10:32,783 THE AMERICAN ACADEMY OF 264 00:10:32,783 --> 00:10:34,351 PEDIATRICS RECOMMENDS VERY LOW 265 00:10:34,351 --> 00:10:36,553 BIRTH WEIGHT INFANTS, LESS THAN 266 00:10:36,553 --> 00:10:39,056 1500 GRAMS, RECEIVE HUMAN MILK, 267 00:10:39,056 --> 00:10:40,791 PREFERABLY FROM THEIR OWN 268 00:10:40,791 --> 00:10:41,892 PARENT. 269 00:10:41,892 --> 00:10:44,861 IF THIS IS NOT AVAILABLE, 270 00:10:44,861 --> 00:10:46,263 PASTEURIZED DONOR MU HAN MILE 271 00:10:46,263 --> 00:10:49,333 BEING IS RECOMMENDED AND HUMAN 272 00:10:49,333 --> 00:10:50,901 MILK OFTEN NEEDS TO BE FORTIFIED 273 00:10:50,901 --> 00:10:52,836 TO MEET THEIR NUTRITIONAL NEEDS. 274 00:10:52,836 --> 00:10:53,603 SO THESE WERE SOME OF THE KIND 275 00:10:53,603 --> 00:10:55,138 OF SHARED STARTING POINTS THAT 276 00:10:55,138 --> 00:10:58,208 THE WORKING GROUP BEGAN WITH. 277 00:10:58,208 --> 00:10:59,710 IN TERMS OF INITIATION OF 278 00:10:59,710 --> 00:11:02,479 ENTERAL FEEDING, THERE HAVE BEEN 279 00:11:02,479 --> 00:11:03,680 A NUMBER OF STUDIES FOR MANY 280 00:11:03,680 --> 00:11:03,880 YEARS. 281 00:11:03,880 --> 00:11:04,982 WE STARTED BY LOOKING AT 282 00:11:04,982 --> 00:11:06,717 DIFFERENT APPROACHES TO FEEDING 283 00:11:06,717 --> 00:11:09,686 AND LOOKING AT HOW SOON TO START 284 00:11:09,686 --> 00:11:11,121 FEET FEEDING OR HOW QUICKLY TO 285 00:11:11,121 --> 00:11:12,789 INCREASE FEEDING AND CLINICAL 286 00:11:12,789 --> 00:11:13,724 TRIALS WITH DIFFERENT APPROACHES 287 00:11:13,724 --> 00:11:15,258 FOR INITIATION OR ADVANCEMENT OF 288 00:11:15,258 --> 00:11:16,693 FEEDING HAVE SHOWN NO CLEAR 289 00:11:16,693 --> 00:11:18,228 EFFECTS ON THE RISK OF 290 00:11:18,228 --> 00:11:25,002 DEVELOPING NEC. 291 00:11:25,002 --> 00:11:27,404 WHEN WE LOOKED AT BASE DIETS AND 292 00:11:27,404 --> 00:11:28,739 RESEARCH AS PART OF THE WORKING 293 00:11:28,739 --> 00:11:30,907 GROUP'S CHARGE ON WHICH BASE 294 00:11:30,907 --> 00:11:32,976 DIET TO FIELD FEED EARLY PRETERM 295 00:11:32,976 --> 00:11:35,512 INFANTS, WHEN THE PARENTS' OWN 296 00:11:35,512 --> 00:11:37,814 MILK IS INSUFFICIENT OR 297 00:11:37,814 --> 00:11:39,783 INAVAILABLE, GIVING DONOR MILK 298 00:11:39,783 --> 00:11:42,819 CAN LOWER THE RISK OF NEC. 299 00:11:42,819 --> 00:11:47,124 RECENT CLINICAL TRIALS HAVE 300 00:11:47,124 --> 00:11:48,759 FOCUSED ON INFANTS LESS THAN 301 00:11:48,759 --> 00:11:50,394 1500 GRAMS AT BIRTH OR LESS THAN 302 00:11:50,394 --> 00:11:51,261 1,000 GRAMS AT BIRTH. 303 00:11:51,261 --> 00:11:52,496 NOW HUMAN MILK SOMETIMES NEEDS 304 00:11:52,496 --> 00:11:54,231 TO BE FORTIFIED TO MEET THE 305 00:11:54,231 --> 00:11:55,732 NUTRITIONAL NEEDS OF PRETERM 306 00:11:55,732 --> 00:11:57,067 INFANTS SO RESEARCH ON HOW TO 307 00:11:57,067 --> 00:12:00,103 FORTIFY THE BASE DIET BY ADDING 308 00:12:00,103 --> 00:12:01,204 SPECIFIC COMPONENTS HAS SHOWN 309 00:12:01,204 --> 00:12:03,073 MIXED RESULTS ON WHETHER TO USE 310 00:12:03,073 --> 00:12:06,343 HUMAN MILK OR BOVINE MILK-BASED 311 00:12:06,343 --> 00:12:07,244 FORTIFIERS. 312 00:12:07,244 --> 00:12:08,311 THESE CLINICAL TRIALS HAVE 313 00:12:08,311 --> 00:12:12,249 TENDED TO BE SMALL WITH TWO FEW 314 00:12:12,249 --> 00:12:13,917 CASES OF NEC TO DRAW FIRM 315 00:12:13,917 --> 00:12:16,420 CONCLUSIONS. 316 00:12:16,420 --> 00:12:17,621 BASED ON THE EXPERIENCE OF THE 317 00:12:17,621 --> 00:12:19,389 EXPERTS IN THE WORKING GROUP AND 318 00:12:19,389 --> 00:12:20,457 PRESENTATIONS, THE WORKING GROUP 319 00:12:20,457 --> 00:12:21,425 IDENTIFIED SEVERAL LIMITATIONS 320 00:12:21,425 --> 00:12:25,295 OF THE EXISTING EVIDENCE ON NEC. 321 00:12:25,295 --> 00:12:26,596 ONE LIMITATION WAS THAT OTHER 322 00:12:26,596 --> 00:12:28,231 INTESTINAL CONDITIONS MAY MIMIC 323 00:12:28,231 --> 00:12:29,866 NEC, WHICH CAN LIMIT SOME OF THE 324 00:12:29,866 --> 00:12:30,734 SURVEILLANCE EVIDENCE FOR NEC. 325 00:12:30,734 --> 00:12:36,540 FOR EXAMPLE, ICD CODES MAY 326 00:12:36,540 --> 00:12:39,843 INCLUDE BOTH NEC AND A SEPARATE 327 00:12:39,843 --> 00:12:41,244 ENTITY IN THE SAME CODE. 328 00:12:41,244 --> 00:12:41,778 ADDITIONALLY MUCH OF THE 329 00:12:41,778 --> 00:12:43,313 EVIDENCE SHOWS ASSOCIATIONS NOT 330 00:12:43,313 --> 00:12:45,182 DIRECT OR INDIRECT CAUSATION, 331 00:12:45,182 --> 00:12:47,484 AND THERE NEEDS TO BE A LINK TO 332 00:12:47,484 --> 00:12:49,453 THE ASSOCIATED CLINICAL RISK 333 00:12:49,453 --> 00:12:51,621 FACTORS FOR DEVELOPMENT AND/OR 334 00:12:51,621 --> 00:12:54,057 PROGRESSION OF NEC FOR 335 00:12:54,057 --> 00:12:54,925 BIOLOGICAL PATHWAYS FOR THE 336 00:12:54,925 --> 00:12:56,760 UNDER DTS LYING MECHANISMS. 337 00:12:56,760 --> 00:12:58,261 SOME OF THE RISK FACTORS HAVE 338 00:12:58,261 --> 00:12:59,830 NOT BEEN CONFIRMED IN CLINICAL 339 00:12:59,830 --> 00:13:00,363 TRIALS. 340 00:13:00,363 --> 00:13:03,467 FOR EXAMPLE, RED CELL 341 00:13:03,467 --> 00:13:05,502 TRANSFUSION AND EMPIRIC USE OF 342 00:13:05,502 --> 00:13:06,736 ANTIBIOTIC TREATMENT WITH 343 00:13:06,736 --> 00:13:07,237 ONGOING CLINICAL TRIALS 344 00:13:07,237 --> 00:13:09,239 CURRENTLY. 345 00:13:09,239 --> 00:13:10,140 ADDITIONALLY, MANY OF THE 346 00:13:10,140 --> 00:13:12,509 EXISTING STUDIES HAVE BEEN SMALL 347 00:13:12,509 --> 00:13:14,277 IN SIZE WITH TOO FEW NEC CASES 348 00:13:14,277 --> 00:13:22,486 TO DRAW FIRM CONCLUSIONS. 349 00:13:22,486 --> 00:13:24,654 NOW THE WORKING GROUP WORKED TO 350 00:13:24,654 --> 00:13:25,288 GENERATE RECOMMENDATIONS TO 351 00:13:25,288 --> 00:13:26,423 COUNCIL SO I'M GOING TO GO OVER 352 00:13:26,423 --> 00:13:27,357 SOME OF THE RECOMMENDATIONS, 353 00:13:27,357 --> 00:13:29,693 THESE ARE RESEARCH 354 00:13:29,693 --> 00:13:30,327 RECOMMENDATIONS FROM THE WORKING 355 00:13:30,327 --> 00:13:32,329 GROUP. 356 00:13:32,329 --> 00:13:33,964 WE HAVE THREE OVERARCHING 357 00:13:33,964 --> 00:13:36,733 RECOMMENDATIONS. 358 00:13:36,733 --> 00:13:37,567 THE FIRST AND OBVIOUSLY THE BEST 359 00:13:37,567 --> 00:13:39,436 WAY TO PREVENT MOST NEC CASES IS 360 00:13:39,436 --> 00:13:41,071 TO PREVENT PRETERM BIRTH. 361 00:13:41,071 --> 00:13:42,305 AND, THEREFORE, THE GROUP 362 00:13:42,305 --> 00:13:43,907 RECOMMENDED THE CONTINUATION AND 363 00:13:43,907 --> 00:13:45,542 EXPANSION OF RESEARCH INTO WAYS 364 00:13:45,542 --> 00:13:48,512 TO PREVENT PRETERM BIRTH. 365 00:13:48,512 --> 00:13:49,613 SECOND, THE WORKING GROUP FELT 366 00:13:49,613 --> 00:13:51,548 WE NEEDED TO DEVELOP A MORE 367 00:13:51,548 --> 00:13:52,549 SPECIFIC DEFINITION OF NEC AND 368 00:13:52,549 --> 00:14:01,191 THE SEVERITY OF NECK NEC TO IME 369 00:14:01,191 --> 00:14:02,325 EPIDEMIOLOGICAL STUDIES AND 370 00:14:02,325 --> 00:14:04,327 DETERMINE ELIGIBILITY FOR TRIALS 371 00:14:04,327 --> 00:14:04,928 AND TREATMENTS. 372 00:14:04,928 --> 00:14:07,097 THIRD WE NEED TO UNDERSTAND THE 373 00:14:07,097 --> 00:14:09,633 RESEARCH AND INCORPORATE THE 374 00:14:09,633 --> 00:14:11,801 PERSPECTIVES OF AFFECTED 375 00:14:11,801 --> 00:14:13,336 FAMILIES, TO BETTER INFORM THEM 376 00:14:13,336 --> 00:14:16,206 ABOUT THE RISK OF NEC AND HOW WE 377 00:14:16,206 --> 00:14:17,474 CAN SUPPORT THEM IN THE 378 00:14:17,474 --> 00:14:19,442 INTENSIVE CARE UNIT. 379 00:14:19,442 --> 00:14:21,211 RELATED TO THE EPIDEMIOLOGY OF 380 00:14:21,211 --> 00:14:22,379 NEC, THE WORKING GROUP 381 00:14:22,379 --> 00:14:23,513 RECOMMENDED THAT WE IMPROVE THE 382 00:14:23,513 --> 00:14:26,049 TRACKING AND REPORTING OF NEC 383 00:14:26,049 --> 00:14:27,684 CASES AS WELL AS DEATHS FROM NEC 384 00:14:27,684 --> 00:14:29,186 TO BETTER QAWBT GUY THE TOTAL 385 00:14:29,186 --> 00:14:30,720 BURDEN OF DISEASE. 386 00:14:30,720 --> 00:14:34,324 AND THAT THIS NEEDS TO BE DONE 387 00:14:34,324 --> 00:14:38,929 USING ICD10 CODES AND BY 388 00:14:38,929 --> 00:14:41,231 STRATIFICATION TO UNDERSTAND THE 389 00:14:41,231 --> 00:14:45,302 IMPACT ON DIFFERENT -- OR MORE 390 00:14:45,302 --> 00:14:46,469 MATURE INFANTS. 391 00:14:46,469 --> 00:14:53,043 ADDITIONALLY THE WORKING 392 00:14:53,043 --> 00:14:54,811 GROUP -- THAT THIS COULD ALLOW 393 00:14:54,811 --> 00:14:56,680 IDENTIFICATION OF DIAGNOSTIC, 394 00:14:56,680 --> 00:14:57,814 PROGNOSTIC, PREDICTIVE 395 00:14:57,814 --> 00:14:59,382 SUSCEPTIBILITY AND/OR SURROGATE 396 00:14:59,382 --> 00:15:02,452 MARKERS FOR NEC. 397 00:15:02,452 --> 00:15:05,622 IN ADDITION, RESEARCH NEEDS TO 398 00:15:05,622 --> 00:15:07,324 EXPLORE INNOVATIVE METHODS FOR 399 00:15:07,324 --> 00:15:08,592 COLLECTING AND ANALYZING DATA. 400 00:15:08,592 --> 00:15:11,528 FOR EXAMPLE, CAN DATA BE USED TO 401 00:15:11,528 --> 00:15:12,862 IMPROVE STIMENTSDZ FOR FACTORS 402 00:15:12,862 --> 00:15:16,333 THAT CONTRIBUTE MOST FOR THE 403 00:15:16,333 --> 00:15:19,636 DEVELOPMENT OF NEC. 404 00:15:19,636 --> 00:15:21,805 WHAT'S THE -- NUTRITIONAL 405 00:15:21,805 --> 00:15:22,906 APPROACHES OR BASELINE 406 00:15:22,906 --> 00:15:23,673 CHARACTERISTICS, AND HOW 407 00:15:23,673 --> 00:15:25,308 ACCURATE ARE THE DIAGNOSIS RATES 408 00:15:25,308 --> 00:15:27,811 FOR NEC. 409 00:15:27,811 --> 00:15:29,145 WERE WHAT TREATMENTS HAVE THE 410 00:15:29,145 --> 00:15:31,214 MOST BENEFICIAL OUTCOMES, AND 411 00:15:31,214 --> 00:15:32,749 CAN ARTIFICIAL INTELLIGENCE OR 412 00:15:32,749 --> 00:15:34,484 MACHINE LEARNING BE USED TO LOOK 413 00:15:34,484 --> 00:15:36,720 AT ELECTRONIC HEALTH RECORDS OR 414 00:15:36,720 --> 00:15:38,555 ROUTINELY COLLECTED DATA OF 415 00:15:38,555 --> 00:15:39,756 BABIES WITH AND WITHOUT NEC TO 416 00:15:39,756 --> 00:15:44,461 IMPROVE THE DIAGNOSTIC CRITERIA. 417 00:15:44,461 --> 00:15:46,096 BIOMARKERS OR SURROGATE MEASURES 418 00:15:46,096 --> 00:15:48,732 TO HELP STUDY NEC GIVEN ITS 419 00:15:48,732 --> 00:15:50,800 RELATIVELY LOW INCIDENCE. 420 00:15:50,800 --> 00:15:58,241 IN TERMS OF MECHANISMS, WE 421 00:15:58,241 --> 00:15:59,643 RECOMMEND EXPANDING RESEARCH 422 00:15:59,643 --> 00:16:00,810 SUPPORT INTO THE MECHANISMS OF 423 00:16:00,810 --> 00:16:03,046 NEC DEVELOPMENT. 424 00:16:03,046 --> 00:16:05,048 WE NEED BIOMARKERS TO IMPROVE 425 00:16:05,048 --> 00:16:06,316 EARLY DIAGNOSIS OF NEC AND TO 426 00:16:06,316 --> 00:16:07,984 ENABLE EARLIER TREATMENT OF NEC 427 00:16:07,984 --> 00:16:09,753 BEFORE THE DISEASE PROGRESSES, 428 00:16:09,753 --> 00:16:10,720 AND UNDERSTANDING AND KNOWING 429 00:16:10,720 --> 00:16:12,722 MORE ABOUT THE UNDERLYING 430 00:16:12,722 --> 00:16:13,356 MECHANISMS OF THE DISEASE WILL 431 00:16:13,356 --> 00:16:16,059 HELP US TO IDENTIFY POTENTIAL 432 00:16:16,059 --> 00:16:17,093 PREVENTION TREATMENT TARGETS, 433 00:16:17,093 --> 00:16:18,461 INCLUDING KNOWING MORE ABOUT THE 434 00:16:18,461 --> 00:16:19,996 GENETIC AND EPIGENETIC PATHWAYS 435 00:16:19,996 --> 00:16:20,864 OF NEC. 436 00:16:20,864 --> 00:16:23,066 WE NEED ADDITIONAL LABORATORY 437 00:16:23,066 --> 00:16:25,035 AND ANIMAL MODELS TO BETTER 438 00:16:25,035 --> 00:16:26,903 MATCH THE DISEASE COMPLEXITY IN 439 00:16:26,903 --> 00:16:28,204 LABORATORY EXPERIMENTS. 440 00:16:28,204 --> 00:16:31,274 THE FIELD HAS DEVELOPED NEC IN A 441 00:16:31,274 --> 00:16:33,243 DISH AND NEC ON A CHIP MODELS 442 00:16:33,243 --> 00:16:35,312 AND ANIMAL MODELS MAINLY IN 443 00:16:35,312 --> 00:16:39,049 MICE, RATS AND PIGS HAVE BEEN 444 00:16:39,049 --> 00:16:40,984 UTILIZED, AND GASTROINTESTINAL 445 00:16:40,984 --> 00:16:43,953 ORGANORGANOID SYSTEMS ARE BEING 446 00:16:43,953 --> 00:16:44,721 DEVELOPED AND USED. 447 00:16:44,721 --> 00:16:46,089 THESE MODELS NEED TO BE EXPANDED 448 00:16:46,089 --> 00:16:47,991 TO INCLUDE THE MULTIFACTORIAL 449 00:16:47,991 --> 00:16:52,462 COMPLEXITIES OF THE DISEASE. 450 00:16:52,462 --> 00:16:53,697 MOVING ON TO THE FACTORS 451 00:16:53,697 --> 00:16:54,564 AFFECTING THE RISK OF NEC. 452 00:16:54,564 --> 00:16:56,533 THE WORKING GROUP RECOMMENDED 453 00:16:56,533 --> 00:16:57,834 EXPLORING EXPOSURES THAT MAY BE 454 00:16:57,834 --> 00:16:58,668 POSITIVELY OR NEGATIVELY 455 00:16:58,668 --> 00:17:00,470 ASSOCIATED WITH THE RISK OF NEC 456 00:17:00,470 --> 00:17:03,306 DEVELOPMENT, SEVERITY, 457 00:17:03,306 --> 00:17:03,640 MORTALITY. 458 00:17:03,640 --> 00:17:06,142 THE EMPHASIS ON SPECIFIC 459 00:17:06,142 --> 00:17:08,011 NUTRITIONAL COMPONENTS, THE USE 460 00:17:08,011 --> 00:17:09,746 OF ANTENATAL AND POSTNATAL 461 00:17:09,746 --> 00:17:13,917 ANTIBIOTICS AND BACTERIAL 462 00:17:13,917 --> 00:17:16,119 DYSBIOSIS AND VIRUSES. 463 00:17:16,119 --> 00:17:16,920 ADDITIONALLY EXPANDING RESEARCH 464 00:17:16,920 --> 00:17:18,188 ON FEEDING PRACTICES THAT MAY 465 00:17:18,188 --> 00:17:20,690 AFFECT THE RISK OF NEC, THIS MAY 466 00:17:20,690 --> 00:17:21,791 INCLUDE WHEN TO START AND HOW 467 00:17:21,791 --> 00:17:24,961 FAST TO INCREASE FEEDINGS IN 468 00:17:24,961 --> 00:17:26,830 VERY LOW BIRTH WEIGHT HUMANS AND 469 00:17:26,830 --> 00:17:28,765 WHAT COMPONENTS OF HUMAN MILK, 470 00:17:28,765 --> 00:17:30,967 FOR THE FIRES AND/OR FORMULA ARE 471 00:17:30,967 --> 00:17:33,269 MOST BENEFICIAL. 472 00:17:33,269 --> 00:17:34,537 RELATED TO NUTRITIONAL SUPPORT, 473 00:17:34,537 --> 00:17:36,339 THE WORKING GROUP RECOMMENDED 474 00:17:36,339 --> 00:17:37,607 SUPPORTING RESEARCH TO IDENTIFY 475 00:17:37,607 --> 00:17:39,175 THE OPTIMAL NUTRITIONAL NEEDS OF 476 00:17:39,175 --> 00:17:39,843 PREMATURE INFANTS. 477 00:17:39,843 --> 00:17:41,144 WHAT DO THESE INFANTS REALLY 478 00:17:41,144 --> 00:17:44,114 NEED TO THRIVE? 479 00:17:44,114 --> 00:17:44,881 INCREASING RESEARCH ON HOW TO 480 00:17:44,881 --> 00:17:46,716 HELP PARENTS INCREASE THEIR MILK 481 00:17:46,716 --> 00:17:49,819 PRODUCTION AND IMPROVE LACTATION 482 00:17:49,819 --> 00:17:50,553 TECHNIQUES. 483 00:17:50,553 --> 00:17:52,756 THIS RESEARCH WOULD BE 484 00:17:52,756 --> 00:17:57,560 BENEFICIAL NOT ONLY TO PRETERM 485 00:17:57,560 --> 00:17:59,529 BUT ALL PRETERM AND TERM INFANTS 486 00:17:59,529 --> 00:17:59,929 BROADLY. 487 00:17:59,929 --> 00:18:01,264 AND SUPPORTING RESEARCH THAT 488 00:18:01,264 --> 00:18:02,065 DETERMINED HOW TO IMPROVE THE 489 00:18:02,065 --> 00:18:03,900 SAFETY OF HUMAN MILK, 490 00:18:03,900 --> 00:18:05,769 PARTICULARLY DONOR MILK BY 491 00:18:05,769 --> 00:18:06,970 COLLECTING, PROCESSING, STORAGE 492 00:18:06,970 --> 00:18:08,371 AND DISPENSING, AND TO BETTER 493 00:18:08,371 --> 00:18:09,939 UNDERSTAND WHAT ARE THE 494 00:18:09,939 --> 00:18:10,807 BIOACTIVE COMPONENTS OF HUMAN 495 00:18:10,807 --> 00:18:12,008 MILK THAT MAIN BE PROTECTED FOR 496 00:18:12,008 --> 00:18:14,411 NEC AND HOW CAN WE PRESERVE 497 00:18:14,411 --> 00:18:16,379 THESE WHILE STILL PROTECTING 498 00:18:16,379 --> 00:18:18,014 AGAINST INFECTIOUS RISKS THAT 499 00:18:18,014 --> 00:18:19,649 MAY BE PRESENT IN DONATED MILK. 500 00:18:19,649 --> 00:18:23,153 AND TO DEVELOP POINT OF CARE 501 00:18:23,153 --> 00:18:25,255 DIAGNOSTICS TO MEASURE MILK 502 00:18:25,255 --> 00:18:28,758 COMPONENTS IN NICUs AND DONOR 503 00:18:28,758 --> 00:18:29,492 BANKS. 504 00:18:29,492 --> 00:18:30,627 ALSO RESEARCH POTENTIAL 505 00:18:30,627 --> 00:18:32,562 STANDARDS FOR DONOR MILK, FOR 506 00:18:32,562 --> 00:18:33,997 EXAMPLE, POSTPARTUM DONATION 507 00:18:33,997 --> 00:18:35,298 TIMING, MILK COMPOSITION, 508 00:18:35,298 --> 00:18:37,500 APPROACHES TO POOLING OF DONOR 509 00:18:37,500 --> 00:18:40,003 MILK, AND OPTIMIZATION OF DONOR 510 00:18:40,003 --> 00:18:41,104 MILK FOR SPECIFIC POPULATION 511 00:18:41,104 --> 00:18:42,639 SUCH AS VERY LOW BIRTH WEIGHT 512 00:18:42,639 --> 00:18:49,312 INFANTS. 513 00:18:49,312 --> 00:18:50,947 THE WORKING GROUP RECOMMENDS TO 514 00:18:50,947 --> 00:18:53,216 THE SECRETARY THAT WE SUPPORT 515 00:18:53,216 --> 00:18:54,984 LARGE INDEPENDENT COMPARATIVE 516 00:18:54,984 --> 00:18:56,419 EFFECTIVENESS CLINICAL TRIALS OF 517 00:18:56,419 --> 00:18:59,022 FEEDING PRACTICES AND NEC RISK. 518 00:18:59,022 --> 00:19:00,890 BECAUSE NEC IS A RELATIVELY RARE 519 00:19:00,890 --> 00:19:02,158 OUTCOME, WE NEED LARGE TRIALS TO 520 00:19:02,158 --> 00:19:03,726 HAVE ENOUGH POWER TO 521 00:19:03,726 --> 00:19:04,327 DEFINITIVELY ANSWER QUESTIONS 522 00:19:04,327 --> 00:19:06,362 ABOUT FEEDING PRACTICES. 523 00:19:06,362 --> 00:19:08,498 THIS WOULD INCLUDE EVALUATION OF 524 00:19:08,498 --> 00:19:09,833 DIFFERENT TYPES OF FORTIFIERS 525 00:19:09,833 --> 00:19:11,734 AND METHODS OF FORTIFICATION 526 00:19:11,734 --> 00:19:14,571 THAT ARE USED TO REDUCE THE RISK 527 00:19:14,571 --> 00:19:15,505 OF NEC. 528 00:19:15,505 --> 00:19:17,407 AS WELL AS HOW AND WHEN TO 529 00:19:17,407 --> 00:19:18,174 TRANSITION BABIES THAT ARE 530 00:19:18,174 --> 00:19:19,909 RECEIVING DONOR MILK OFF OF 531 00:19:19,909 --> 00:19:22,979 DONOR MILK WHEN THE TIME COMES. 532 00:19:22,979 --> 00:19:24,848 AS PART OF THAT, WE NEED TO 533 00:19:24,848 --> 00:19:25,849 DEVELOP INNOVATIVE CLINICAL 534 00:19:25,849 --> 00:19:27,150 TRIALS THAT CAN TEST THE SAFETY 535 00:19:27,150 --> 00:19:29,652 AND EFFICACY OF PROMISING 536 00:19:29,652 --> 00:19:32,155 NUTRITIONAL ADDITIVES TO PREVENT 537 00:19:32,155 --> 00:19:34,157 AND/OR TREAT NEC. 538 00:19:34,157 --> 00:19:38,061 FOR EXAMPLE, PROBIOTICS THAT 539 00:19:38,061 --> 00:19:39,062 SHOW PROMISE, WE NEED WAYS TO 540 00:19:39,062 --> 00:19:40,497 DEVELOP AND MANUFACTURE THESE 541 00:19:40,497 --> 00:19:41,197 PRODUCTS CONSISTENTLY SO THAT 542 00:19:41,197 --> 00:19:44,334 THEY CAN BE TESTED AND EVALUATED 543 00:19:44,334 --> 00:19:45,535 IN NEONATES. 544 00:19:45,535 --> 00:19:50,240 WE NEED WAYS TO TEST MULTIPLE 545 00:19:50,240 --> 00:19:52,509 COMPONENTS WORKING TOGETHER, WE 546 00:19:52,509 --> 00:19:54,277 MAY FIND WE NEED ONE OR MORE 547 00:19:54,277 --> 00:19:56,246 INGREDIENT TO OPTIMIZE 548 00:19:56,246 --> 00:19:57,113 PREVENTION IN OUR TREATMENT OF 549 00:19:57,113 --> 00:19:58,214 NEC. 550 00:19:58,214 --> 00:20:00,383 FINALLY WE RECOMMEND EXPANDING 551 00:20:00,383 --> 00:20:01,484 IMPLEMENTATION SCIENCE RESEARCH 552 00:20:01,484 --> 00:20:04,654 TO REDUCE DISPARITIES IN ACCESS 553 00:20:04,654 --> 00:20:06,856 TO DONOR MILK. 554 00:20:06,856 --> 00:20:08,591 ARE THERE BARRIERS TO ACCESSING 555 00:20:08,591 --> 00:20:10,527 DONOR MILK IN RURAL COMMUNITIES, 556 00:20:10,527 --> 00:20:11,995 HOSPITALS OR IN MINORITY MOP 557 00:20:11,995 --> 00:20:15,698 LAITIPOPULATIONS AND HOW CAN WE 558 00:20:15,698 --> 00:20:19,969 BETTER SUPPORT RESEARCH AND HOW 559 00:20:19,969 --> 00:20:21,538 CAN WE IMPROVE LACTATION SUPPORT 560 00:20:21,538 --> 00:20:22,505 FOR NEW MOTHERS? 561 00:20:22,505 --> 00:20:23,806 LASTLY, WE NEED SUPPORT ON 562 00:20:23,806 --> 00:20:24,908 RESEARCH ON PARENT EDUCATION, 563 00:20:24,908 --> 00:20:26,643 HOW CAN WE BEST INFORM PARENTS 564 00:20:26,643 --> 00:20:28,511 IN THE NICU ABOUT OPTIMAL 565 00:20:28,511 --> 00:20:30,046 FEEDING PRACTICES AND THE RISK 566 00:20:30,046 --> 00:20:31,014 OF PRETERM CONDITIONS SUCH AS 567 00:20:31,014 --> 00:20:35,018 NEC. 568 00:20:35,018 --> 00:20:36,386 THE NEXT STEPS FOR THIS WORKING 569 00:20:36,386 --> 00:20:39,989 GROUP ARE TO FINALIZE A REPORT 570 00:20:39,989 --> 00:20:41,624 OF OUR FINDINGS AND 571 00:20:41,624 --> 00:20:42,625 RECOMMENDATIONS AND SUBMIT THIS 572 00:20:42,625 --> 00:20:44,193 REPORT TO THE SECRETARY OF 573 00:20:44,193 --> 00:20:45,695 HEALTH AND HUMAN SERVICES BY 574 00:20:45,695 --> 00:20:50,967 SEPTEMBER 16TH OF THIS YEAR. 575 00:20:50,967 --> 00:20:52,468 I WANT TO FINISH BY REALLY 576 00:20:52,468 --> 00:20:53,870 THANKING THE WORKING GROUP 577 00:20:53,870 --> 00:20:55,838 MEMBERS FOR THEIR DEDICATION AND 578 00:20:55,838 --> 00:20:57,907 WILLINGNESS TO COME TOGETHER ON 579 00:20:57,907 --> 00:21:04,047 SUCH SHORT NOTICE, MY CO-CHAIR, 580 00:21:04,047 --> 00:21:05,181 DR. MALDONADO AND MY COLLEAGUES 581 00:21:05,181 --> 00:21:09,519 AT NIH AND NICHD ON MOVING THIS 582 00:21:09,519 --> 00:21:10,286 PROCESS FORWARD. 583 00:21:10,286 --> 00:21:11,454 SO THANK YOU TO ALL THAT HAVE 584 00:21:11,454 --> 00:21:12,589 BEEN INVOLVED AND I THINK WE 585 00:21:12,589 --> 00:21:13,690 HAVE SOME TIME FOR QUESTIONS AND 586 00:21:13,690 --> 00:21:17,760 FEEDBACK. 587 00:21:17,760 --> 00:21:21,698 >> THANK YOU, DRS. PATEL AND 588 00:21:21,698 --> 00:21:22,632 MALDONADO FOR SUCH AN 589 00:21:22,632 --> 00:21:23,199 INFORMATIVE REPORT. 590 00:21:23,199 --> 00:21:24,400 NOW IS THE CHANCE FOR THE 591 00:21:24,400 --> 00:21:26,903 COUNCIL TO PROVIDE FURTHER 592 00:21:26,903 --> 00:21:27,236 DISCUSSION. 593 00:21:27,236 --> 00:21:29,772 SO THE FLOOR IS OPEN, AND WE 594 00:21:29,772 --> 00:21:31,608 REALLY ENCOURAGE YOUR QUESTIONS 595 00:21:31,608 --> 00:21:33,676 AND ADDITIONAL THOUGHTS BECAUSE 596 00:21:33,676 --> 00:21:34,844 WE WILL INCORPORATE THEM INTO 597 00:21:34,844 --> 00:21:40,817 THE REPORT. 598 00:21:40,817 --> 00:21:42,452 >> THAT WAS REALLY EXCELLENT. 599 00:21:42,452 --> 00:21:43,987 THANK YOU BOTH AND THE 600 00:21:43,987 --> 00:21:49,859 COMMITTEE. 601 00:21:49,859 --> 00:21:55,365 BUT I HAD A QUESTION, MAYBE THIS 602 00:21:55,365 --> 00:22:02,672 IS -- IT'S GREEN. 603 00:22:02,672 --> 00:22:05,942 SO THIS IS -- PROBABLY REFLECTS 604 00:22:05,942 --> 00:22:08,244 MY OWN IGNORANCE AND MAYBE SEEMS 605 00:22:08,244 --> 00:22:09,679 SIMPLISTIC AND MAYBE IT'S BEEN 606 00:22:09,679 --> 00:22:17,086 DONE, BUT IF HUMAN MILK IS BEST, 607 00:22:17,086 --> 00:22:19,422 HAVE PEOPLE, WHETHER IT'S SOME 608 00:22:19,422 --> 00:22:21,290 SEPARATION TECHNIQUE, HPLC, 609 00:22:21,290 --> 00:22:22,825 WHATEVER IT IS, HAS SOMEBODY 610 00:22:22,825 --> 00:22:25,862 LOOKED AT HUMAN MILK VERSUS 611 00:22:25,862 --> 00:22:28,164 FORMULA TO SEE WHAT IT IS THAT'S 612 00:22:28,164 --> 00:22:30,033 EITHER GOOD IN HUMAN MILK OR BAD 613 00:22:30,033 --> 00:22:36,472 IN FORMULA SO THAT YOU CAN BE, 614 00:22:36,472 --> 00:22:37,674 WHEN HUMAN MILK IS NOT 615 00:22:37,674 --> 00:22:39,008 AVAILABLE, HAVE -- EXCUSE ME -- 616 00:22:39,008 --> 00:22:40,309 A BETTER ALTERNATIVE? 617 00:22:40,309 --> 00:22:42,178 DO WE KNOW WHY HUMAN MILK IS 618 00:22:42,178 --> 00:22:46,883 GOOD? 619 00:22:46,883 --> 00:22:50,386 >> I CAN TAKE THAT. 620 00:22:50,386 --> 00:22:51,988 THAT'S A GREAT QUESTION. 621 00:22:51,988 --> 00:22:54,190 THERE WERE SPECIFIC 622 00:22:54,190 --> 00:22:54,957 PRESENTATIONS BY -- AS PART OF 623 00:22:54,957 --> 00:22:56,392 THIS WORKING GROUP SPECIFICALLY 624 00:22:56,392 --> 00:22:58,561 ON THAT IMPORTANT QUESTION. 625 00:22:58,561 --> 00:23:01,197 THERE ARE A NUMBER FACTORS THAT 626 00:23:01,197 --> 00:23:09,172 WERE REVIEWED INCLUDING 627 00:23:09,172 --> 00:23:10,606 OLIGOSACCHARIDES, GROWTH FACTOR, 628 00:23:10,606 --> 00:23:11,808 A NUMBER OF OTHER COMPONENTS 629 00:23:11,808 --> 00:23:16,646 THAT MAY EXPLAIN THE BENEFITS ON 630 00:23:16,646 --> 00:23:18,815 INTESTINAL HEALTH, INTESTINAL 631 00:23:18,815 --> 00:23:20,016 MATURATION, AND SO THOSE ARE 632 00:23:20,016 --> 00:23:21,217 THINGS THAT HAVE BEEN LOOKED AT. 633 00:23:21,217 --> 00:23:22,418 IT MAY BE THAT THE ABSENCE OF 634 00:23:22,418 --> 00:23:23,619 THOSE FACTORS OR THE LACK OF 635 00:23:23,619 --> 00:23:24,921 THOSE BENEFICIAL FACTORS MIGHT 636 00:23:24,921 --> 00:23:28,191 INFLUENCE THE RISK OF KIND OF 637 00:23:28,191 --> 00:23:30,693 SOME OF THE RISK THAT'S 638 00:23:30,693 --> 00:23:31,594 ATTRIBUTABLE TO NEC AS IT 639 00:23:31,594 --> 00:23:33,362 RELATES TO FEEDING PRACTICES. 640 00:23:33,362 --> 00:23:35,965 I DON'T KNOW IF DR. MALDONADO 641 00:23:35,965 --> 00:23:37,800 HAS ANYTHING SHE'D LIKE TO ADD. 642 00:23:37,800 --> 00:23:41,104 >> WE HAD A SERIES OF EXPERTS 643 00:23:41,104 --> 00:23:45,742 WHO DID COME IN AND TALK TO US 644 00:23:45,742 --> 00:23:48,511 ABOUT ALL OF THE DIFFERENT 645 00:23:48,511 --> 00:23:50,446 STUDIES AND COMPONENTS IN VITRO 646 00:23:50,446 --> 00:23:52,548 AND IN VIVO LOOKING AT 647 00:23:52,548 --> 00:23:53,983 INDIVIDUAL COMPONENTS BUT TAKEN 648 00:23:53,983 --> 00:23:55,051 TOGETHER, THERE'S STILL A DERTH 649 00:23:55,051 --> 00:23:56,185 OF INFORMATION ABOUT WHICH 650 00:23:56,185 --> 00:23:58,254 INDIVIDUAL FACTORS ARE REALLY 651 00:23:58,254 --> 00:23:59,889 GOOD AT PROMOTING GUT HEALTH, 652 00:23:59,889 --> 00:24:01,324 NUTRITION, ET CETERA. 653 00:24:01,324 --> 00:24:02,492 SO THERE ARE SOME INDIVIDUAL 654 00:24:02,492 --> 00:24:03,693 COMPONENTS THAT DR. PATEL 655 00:24:03,693 --> 00:24:04,927 MENTIONED AND OTHERS, BUT IT'S 656 00:24:04,927 --> 00:24:08,531 NOT CLEAR WHICH ONES ARE BEST IN 657 00:24:08,531 --> 00:24:10,266 HUMAN MILK AND WHAT'S MISSING IN 658 00:24:10,266 --> 00:24:12,668 FORMULA MILK, OR IS FORMULA 659 00:24:12,668 --> 00:24:13,569 ACTUALLY -- DOES FORMULA HAVE 660 00:24:13,569 --> 00:24:15,738 COMPONENTS THAT ARE DETRIMENTAL. 661 00:24:15,738 --> 00:24:16,773 SO THAT'S STILL NOT CLEAR. 662 00:24:16,773 --> 00:24:21,978 >> BUT I DIDN'T SEE THAT AS A 663 00:24:21,978 --> 00:24:23,412 RECOMMENDED RESEARCH AREA, WHICH 664 00:24:23,412 --> 00:24:25,915 SEEMS LIKE THAT WOULD BE VERY 665 00:24:25,915 --> 00:24:27,283 FRUITFUL, TO EITHER FIND OUT 666 00:24:27,283 --> 00:24:28,751 WHAT'S BAD IN FORMULA OR FIND 667 00:24:28,751 --> 00:24:30,386 OUT WHAT'S GOOD IN HUMAN MILK. 668 00:24:30,386 --> 00:24:31,387 SEEMS LIKE THAT WOULD BE 669 00:24:31,387 --> 00:24:35,324 SOMETHING THAT WOULD BE 670 00:24:35,324 --> 00:24:39,162 IMPORTANT TO DO BECAUSE YOU MAY 671 00:24:39,162 --> 00:24:40,897 END UP HAVING TO CREATE SOME 672 00:24:40,897 --> 00:24:42,098 ALTERNATIVE BUT WITHOUT KNOWING 673 00:24:42,098 --> 00:24:44,400 WHAT INGREDIENTS YOU NEED, 674 00:24:44,400 --> 00:24:50,439 YOU'RE IN TROUBLE. 675 00:24:50,439 --> 00:24:52,008 >> SO INDIRECTLY, ONE OF THE 676 00:24:52,008 --> 00:24:54,343 AREAS THAT WE LOOKED AT IS 677 00:24:54,343 --> 00:24:55,444 SUPPORTING RESEARCH TO IDENTIFY 678 00:24:55,444 --> 00:24:57,814 THE OPTIMAL NUTRITIONAL NEEDS OF 679 00:24:57,814 --> 00:24:59,615 PREMATURE INFANTS, AND THEN THE 680 00:24:59,615 --> 00:25:02,552 OTHER AREA WAS LOOKING AT 681 00:25:02,552 --> 00:25:03,986 SPECIFIC MODELS, FOR EXAMPLE, 682 00:25:03,986 --> 00:25:07,256 NEC ON A CHIP OR NEC 683 00:25:07,256 --> 00:25:08,357 ORGANOID-TYPE MODEL, SO TRYING 684 00:25:08,357 --> 00:25:12,695 TO IDENTIFY WAYS TO PULL APART 685 00:25:12,695 --> 00:25:13,429 THOSE PARTICULAR COMPONENTS. 686 00:25:13,429 --> 00:25:13,830 >> THANK YOU. 687 00:25:13,830 --> 00:25:15,731 SO WE HAVE A QUESTION ONLINE 688 00:25:15,731 --> 00:25:20,002 FROM DR. BARKIN, THEN WE'LL GO 689 00:25:20,002 --> 00:25:22,972 TO DRS. NEIL PERI -- 690 00:25:22,972 --> 00:25:24,373 >> THANK YOU, GOOD MORNING, 691 00:25:24,373 --> 00:25:25,708 EVERYONE CH AND THANKS TO 692 00:25:25,708 --> 00:25:27,210 DR. PATEL AND MALDONADO FOR THIS 693 00:25:27,210 --> 00:25:27,977 IMPORTANT WORK AND THE LARGE 694 00:25:27,977 --> 00:25:31,047 TEAM THAT SUPPORTED YOU. 695 00:25:31,047 --> 00:25:32,481 JUST TWO COMMENTS, AND I THINK 696 00:25:32,481 --> 00:25:34,951 APROPOS OF THE FIRST COMMENT, WE 697 00:25:34,951 --> 00:25:36,219 KNOW THE MICROBIOME REALLY MAKES 698 00:25:36,219 --> 00:25:37,954 A DIFFERENCE THERE, AND WE NOW 699 00:25:37,954 --> 00:25:39,155 HAVE EMERGING TECHNOLOGY SO WE 700 00:25:39,155 --> 00:25:40,556 CAN ASK AND ANSWER DIFFERENT 701 00:25:40,556 --> 00:25:42,325 QUESTIONS TO TRY TO BETTER 702 00:25:42,325 --> 00:25:44,393 ARTICULATE AND IDENTIFY WHAT 703 00:25:44,393 --> 00:25:46,162 THOSE ELEMENTS ARE RELATED TO 704 00:25:46,162 --> 00:25:47,129 THE MICROBIOME. 705 00:25:47,129 --> 00:25:49,966 MY QUESTION IS, I'M REALLY 706 00:25:49,966 --> 00:25:53,436 STRUCK BY THE FACT THAT ONLY 356 707 00:25:53,436 --> 00:25:55,438 CHILDREN DIE A YEAR OF NEC, AND 708 00:25:55,438 --> 00:26:01,244 EVERY DEATH IS A TRAGEDY, SO 356 709 00:26:01,244 --> 00:26:03,746 IS STILL TOO LARGE OF A NUMBER. 710 00:26:03,746 --> 00:26:06,048 AND YET IF YOU COMPARE THE 711 00:26:06,048 --> 00:26:07,416 NUMBER OF NEONATES THAT HAVE ALL 712 00:26:07,416 --> 00:26:10,119 OF THE RISK FACTORS THAT YOU ALL 713 00:26:10,119 --> 00:26:14,590 AR TAXICAB LATED TO THOSE WHO 714 00:26:14,590 --> 00:26:15,691 DON'T, AND THOSE WHO HAVE THE 715 00:26:15,691 --> 00:26:17,326 SAME RISK FACTORS AND DON'T GET 716 00:26:17,326 --> 00:26:19,629 NEC, VERSUS THOSE THAT DO, THERE 717 00:26:19,629 --> 00:26:22,231 IS A LOT OF GOOD DATA TO BE 718 00:26:22,231 --> 00:26:25,635 FOUND IN THOSE THAT DON'T GET 719 00:26:25,635 --> 00:26:26,068 NEC. 720 00:26:26,068 --> 00:26:27,403 I JUST WANTED TO UNDERSTAND IF 721 00:26:27,403 --> 00:26:31,440 THE COMMITTEE PULLED THAT 722 00:26:31,440 --> 00:26:32,775 FORWARD TO LOOK AT SORT OF THE 723 00:26:32,775 --> 00:26:35,244 FOUND PILOTS, THE POSITIVE 724 00:26:35,244 --> 00:26:36,112 OUTLIERS, TO LEARN FROM THEM AS 725 00:26:36,112 --> 00:26:36,312 WELL. 726 00:26:36,312 --> 00:26:37,580 THANK YOU. 727 00:26:37,580 --> 00:26:41,918 >> WELL, I'LL LET DR. PATEL TAKE 728 00:26:41,918 --> 00:26:43,119 THE FIRST ANSWER -- FIRST STEP 729 00:26:43,119 --> 00:26:44,253 IN ANSWERING THAT AND THEN I 730 00:26:44,253 --> 00:26:46,889 HAVE MY OWN COMMENTS. 731 00:26:46,889 --> 00:26:48,190 >> THAT'S A GREAT POINT. 732 00:26:48,190 --> 00:26:50,693 YOU KNOW, WE KNOW THAT BABIES 733 00:26:50,693 --> 00:26:51,894 WHO, FOR EXAMPLE, RECEIVE ONLY 734 00:26:51,894 --> 00:26:53,763 HUMAN MILK STILL ARE AT RISK OF 735 00:26:53,763 --> 00:26:57,800 NEC AND WE DON DON'T UNDERSTANDY 736 00:26:57,800 --> 00:27:01,170 THAT IS, SOME OF THE -- WHAT ARE 737 00:27:01,170 --> 00:27:02,371 THE FACTORS THAT WE UNDERSTAND 738 00:27:02,371 --> 00:27:03,673 THAT CAN EXPLAIN NEC AND MAYBE 739 00:27:03,673 --> 00:27:04,740 THERE'S SOME RESIDUAL 740 00:27:04,740 --> 00:27:06,676 UNCERTAINTY AND I THINK TRYING 741 00:27:06,676 --> 00:27:08,611 TO UNDERSTAND WHY SO THAT EVEN 742 00:27:08,611 --> 00:27:10,146 IN INFANTS WHO SEEMINGLY MAY NOT 743 00:27:10,146 --> 00:27:11,914 HAVE SOME OF THOSE RISK FACTORS 744 00:27:11,914 --> 00:27:13,516 THAT DEVELOP IT OR EXPERIENCE 745 00:27:13,516 --> 00:27:15,718 THOSE, I THINK THAT THERE IS 746 00:27:15,718 --> 00:27:18,688 TOONT TO BETTER UNDERSTAND THAT 747 00:27:18,688 --> 00:27:21,157 BECAUSE IT IS RELATIVELY 748 00:27:21,157 --> 00:27:22,291 UNCOMMON WHEN YOU THINK OF THE 749 00:27:22,291 --> 00:27:24,360 VERY LOW BIRTH WEIGHT POPULATION 750 00:27:24,360 --> 00:27:25,127 AND OVERALL INCIDENCE. 751 00:27:25,127 --> 00:27:27,229 AND TO THE POINT ABOUT THE 752 00:27:27,229 --> 00:27:29,598 MICROBIOME, THAT WAS IMPORTANT 753 00:27:29,598 --> 00:27:30,967 PART, ONE OF THE RECOMMENDATIONS 754 00:27:30,967 --> 00:27:33,769 ABOUT UNDERSTANDING DYSBIOSIS AS 755 00:27:33,769 --> 00:27:34,971 WELL AS INFECTIONS HAVE BEEN 756 00:27:34,971 --> 00:27:36,939 ASSOCIATED WITH KIND OF AN 757 00:27:36,939 --> 00:27:38,274 IMBALANCE AND ABUNDANCE OF 758 00:27:38,274 --> 00:27:41,544 SPECIFIC TYPES OF INTESTINAL 759 00:27:41,544 --> 00:27:42,244 BACTERIA LIKE PROTEOBACTERIA 760 00:27:42,244 --> 00:27:43,512 HAVE BEEN ASSOCIATED WITH THE 761 00:27:43,512 --> 00:27:44,947 RISK AND IT'S STILL NOT CLEAR 762 00:27:44,947 --> 00:27:46,015 WHAT'S DRIVING THAT CHANGE IN 763 00:27:46,015 --> 00:27:47,049 THE MICROBIOME AND I THINK 764 00:27:47,049 --> 00:27:47,783 OPPORTUNITIES TO BETTER 765 00:27:47,783 --> 00:27:49,652 UNDERSTAND THAT. 766 00:27:49,652 --> 00:27:52,488 >> SO DR. BARKIN, TO YOUR POINT, 767 00:27:52,488 --> 00:27:55,558 WE'VE TALKED ABOUT THIS FROM AN 768 00:27:55,558 --> 00:27:56,625 EPIDEMIOLOGIC PERSPECTIVE AS 769 00:27:56,625 --> 00:28:00,162 WELL, SO GIVEN THE ALMOST 770 00:28:00,162 --> 00:28:01,564 4 MILLION BIRTHS A YEAR, WE 771 00:28:01,564 --> 00:28:03,966 THINK THAT THERE ARE ABOUT 772 00:28:03,966 --> 00:28:07,570 ALMOST 60 FOW PREMATURE BIRTHS 773 00:28:07,570 --> 00:28:09,105 AND AMONG THOSE, THE HIGHEST 774 00:28:09,105 --> 00:28:11,207 RISKS ARE THE VERY LOW BIRTH 775 00:28:11,207 --> 00:28:12,508 WEIGHT INFANTS AND THE QUESTION 776 00:28:12,508 --> 00:28:13,609 WOULD BE THEN, THE MORTALITY 777 00:28:13,609 --> 00:28:15,311 THAT YOU SEE REALLY AS YOU 778 00:28:15,311 --> 00:28:17,079 MENTIONED IS THE TIP OF THE 779 00:28:17,079 --> 00:28:22,451 ICEBERG, BUT ARE THERE -- OF 780 00:28:22,451 --> 00:28:24,086 NEC, IS THERE A PROGRESSION OF 781 00:28:24,086 --> 00:28:27,023 DISEASE AND WHAT HAPPENS TO 782 00:28:27,023 --> 00:28:28,691 CHILDREN IN THE INTENSIVE CARE 783 00:28:28,691 --> 00:28:29,658 NURSERY, FOR EXAMPLE, THAT ARE 784 00:28:29,658 --> 00:28:32,395 PUT ON NEC PROPHYLAXIS OR NEC 785 00:28:32,395 --> 00:28:34,663 PREVENTIVE MEASURES AND WHAT ARE 786 00:28:34,663 --> 00:28:36,465 THOSE FACTORS AND HOW DO THEY 787 00:28:36,465 --> 00:28:38,200 COMPARE TO, SAY, THE CHILDREN 788 00:28:38,200 --> 00:28:39,835 WHO ULTIMATELY DEVELOP FULL 789 00:28:39,835 --> 00:28:42,138 BLOWN DISEASE AND/OR DIE, AN 790 00:28:42,138 --> 00:28:44,774 WHAT CAN WE -- HOW CAN WE PULL 791 00:28:44,774 --> 00:28:46,008 OUT ANY OF THOSE VARIABLES AND 792 00:28:46,008 --> 00:28:46,942 UNDERSTAND THAT. 793 00:28:46,942 --> 00:28:47,710 SO THAT WAS ONE OF THE 794 00:28:47,710 --> 00:28:48,944 RECOMMENDATIONS, IS 795 00:28:48,944 --> 00:28:49,779 UNDERSTANDING MORE ABOUT THE 796 00:28:49,779 --> 00:28:52,748 PREVALENCE OF DISEASE OVERALL, 797 00:28:52,748 --> 00:28:54,950 LOOKING AT END POINTS, AND 798 00:28:54,950 --> 00:28:56,886 FINALLY LOOKING AT, SAY, DEEP 799 00:28:56,886 --> 00:28:57,987 DIVES INTO ELECTRONIC HEALTH 800 00:28:57,987 --> 00:29:02,158 RECORDS TO TRY TO UNDERSTAND THE 801 00:29:02,158 --> 00:29:03,259 BIGGER DENOMINATOR OF CHILDREN 802 00:29:03,259 --> 00:29:04,527 WHO MAY HAVE SOME EARLIER 803 00:29:04,527 --> 00:29:05,661 VERSIONS OF THIS AND HOW THEY 804 00:29:05,661 --> 00:29:07,063 MIGHT BE DIFFERENT, FOR EXAMPLE, 805 00:29:07,063 --> 00:29:10,166 FROM THE CHILDREN WHO ULTIMATELY 806 00:29:10,166 --> 00:29:13,302 SUCCUMB TO THE DISEASE. 807 00:29:13,302 --> 00:29:16,072 >> I REALLY LIKE THIS MOTION, 808 00:29:16,072 --> 00:29:20,009 WHICH IS WE ARE PROBABLY 809 00:29:20,009 --> 00:29:20,976 UNDERDIAGNOSING MANY DIFFERENT 810 00:29:20,976 --> 00:29:22,078 PHENOTYPES OF NEC SO I THINK 811 00:29:22,078 --> 00:29:26,015 THAT'S SUCH AN IMPORTANT 812 00:29:26,015 --> 00:29:26,382 RECOMMENDATION. 813 00:29:26,382 --> 00:29:27,983 I JUST WOULD ENCOURAGE THE 814 00:29:27,983 --> 00:29:29,118 COMMITTEE TO PULL OUT AS A 815 00:29:29,118 --> 00:29:31,387 RECOMMENDATION UNDERSTANDING 816 00:29:31,387 --> 00:29:33,456 CHILDREN WHO HAVE THE SAME RISK 817 00:29:33,456 --> 00:29:34,990 FACTORS BUT DON'T GO ON TO HAVE 818 00:29:34,990 --> 00:29:35,157 NEC. 819 00:29:35,157 --> 00:29:36,392 THAT'S A REALLY RICH GROUP TO 820 00:29:36,392 --> 00:29:36,959 LEARN FROM AS WELL. 821 00:29:36,959 --> 00:29:40,162 THANK YOU. 822 00:29:40,162 --> 00:29:42,098 >> THANK YOU. 823 00:29:42,098 --> 00:29:45,267 >> CAN YOU HEAR ME OKAY? 824 00:29:45,267 --> 00:29:46,135 ACTUALLY, SHARI ACTUALLY ASKED 825 00:29:46,135 --> 00:29:46,936 SOME OF THE QUESTIONS THAT I 826 00:29:46,936 --> 00:29:48,003 HAD. 827 00:29:48,003 --> 00:29:49,405 THE OTHER THING I GUESS I WOULD 828 00:29:49,405 --> 00:29:50,873 ADD TO THAT IS, ONE OF THE 829 00:29:50,873 --> 00:29:53,476 THINGS THAT YOU IDENTIFY AS A 830 00:29:53,476 --> 00:29:57,513 PROTECTIVE FACTOR IS STEROIDS. 831 00:29:57,513 --> 00:29:58,280 AND JUST UNDERSTANDING A LITTLE 832 00:29:58,280 --> 00:30:00,015 BIT MORE ABOUT STEROIDS ACTUALLY 833 00:30:00,015 --> 00:30:06,255 MAY MODIFY THE GUT MICROBIOME 834 00:30:06,255 --> 00:30:08,257 AND WHY THAT'S PROTECTIVE, 835 00:30:08,257 --> 00:30:09,125 BECAUSE ONE WOULD THINK THAT 836 00:30:09,125 --> 00:30:11,293 STEROIDS, YOU KNOW, DO SPECIFIC 837 00:30:11,293 --> 00:30:13,596 THINGS TO THE GUT MICROBIOME. 838 00:30:13,596 --> 00:30:15,131 AND THIS IS A SEPARATE QUESTION 839 00:30:15,131 --> 00:30:18,067 BUT DO YOU HAVE ANY LONG-TERM 840 00:30:18,067 --> 00:30:21,704 HEALTH OUTCOMES FOR KIDS WHO DID 841 00:30:21,704 --> 00:30:23,973 NOT QUITE GET FULL BLOWN NEC BUT 842 00:30:23,973 --> 00:30:26,275 HAVE HAD SOME VERY SERIOUS 843 00:30:26,275 --> 00:30:28,177 ILLNESS IN TERMS OF WHAT THEIR 844 00:30:28,177 --> 00:30:29,345 HEALTH STATUS HAS BEEN AS 845 00:30:29,345 --> 00:30:31,647 THEY'VE DEVELOPED? 846 00:30:31,647 --> 00:30:33,382 ARE THEY AT INCREASED RISK FOR 847 00:30:33,382 --> 00:30:34,316 OTHER DISEASES? 848 00:30:34,316 --> 00:30:38,220 >> SO THE FIRST QUESTION WAS 849 00:30:38,220 --> 00:30:39,855 ABOUT CORTICOSTEROID USE AND 850 00:30:39,855 --> 00:30:41,390 RISK AND THE SECOND QUESTION WAS 851 00:30:41,390 --> 00:30:41,857 CHILDREN WHO -- 852 00:30:41,857 --> 00:30:43,626 >> UNDERSTANDING THE LIFECOURSE 853 00:30:43,626 --> 00:30:45,327 OF CHILDREN WHO DID NOT HAVE 854 00:30:45,327 --> 00:30:47,096 FULL BLOWN NEC BUT THEY HAD BEEN 855 00:30:47,096 --> 00:30:48,397 SICK AND HOSPITALIZED FOR A LONG 856 00:30:48,397 --> 00:30:49,598 TIME, DO YOU KNOW WHETHER 857 00:30:49,598 --> 00:30:51,567 THEY'RE AT ANY INCREASED RISK 858 00:30:51,567 --> 00:30:55,838 FOR OTHER DISORDERS IN LIFE? 859 00:30:55,838 --> 00:30:58,240 >> RAVI, DO YOU WANT TO TAKE THE 860 00:30:58,240 --> 00:30:58,474 FIRST -- 861 00:30:58,474 --> 00:31:03,145 >> IN TERMS OF -- STEROID 862 00:31:03,145 --> 00:31:03,779 ADMINISTRATION PARTICULARLY IN 863 00:31:03,779 --> 00:31:05,681 THE EARLY PRETERM INFANTS HAS A 864 00:31:05,681 --> 00:31:07,316 NUMBER OF EFFECTS BROADLY IN 865 00:31:07,316 --> 00:31:14,323 TERMS OF IMPROVEMENT IN 866 00:31:14,323 --> 00:31:16,959 SURVIVAL, IN TERMS OF PRODUCTION 867 00:31:16,959 --> 00:31:19,428 IN A NUMBER OF OUTCOMES -- 868 00:31:19,428 --> 00:31:20,429 REDUCTION IN A NUMBER OF 869 00:31:20,429 --> 00:31:21,263 OUTCOMES INCLUDING NEC. 870 00:31:21,263 --> 00:31:24,200 IN TERMS OF LONG TERM OUTCOMES, 871 00:31:24,200 --> 00:31:27,136 MOST OF THE STUDIES HAVE FOCUSED 872 00:31:27,136 --> 00:31:29,638 ON TWO-YEAR OUTCOMES. 873 00:31:29,638 --> 00:31:31,173 MOST HAVE BEEN FOCUSED ON THOSE 874 00:31:31,173 --> 00:31:32,374 INFANTS WHO HAVE MORE 875 00:31:32,374 --> 00:31:35,110 SIGNIFICANT DISEASE SUCH AS 876 00:31:35,110 --> 00:31:35,844 SURGERY, REQUIRES SURGERY WHERE 877 00:31:35,844 --> 00:31:37,313 WE KNOW THERE'S A SUBSTANTIAL 878 00:31:37,313 --> 00:31:37,947 LONG TERM BURDEN OF DISEASE. 879 00:31:37,947 --> 00:31:41,450 I THINK WE KNOW LESS ABOUT THE 880 00:31:41,450 --> 00:31:42,885 MILDER CASES, THOSE INFANTS WHO 881 00:31:42,885 --> 00:31:44,753 MIGHT BE MEDICALLY MANAGED AND 882 00:31:44,753 --> 00:31:45,821 RECOVER WITHOUT NEED FOR 883 00:31:45,821 --> 00:31:47,022 SURGERY, AND WHAT THE IMPACT OF 884 00:31:47,022 --> 00:31:49,325 THAT IS, BUT WE'VE HEARD FROM 885 00:31:49,325 --> 00:31:53,162 FAMILIES AND SURVIVORS WHO ARE 886 00:31:53,162 --> 00:31:54,463 IN ADULTHOOD THAT DEVELOP NEC 887 00:31:54,463 --> 00:31:56,098 AND SOME OF THE LONG-LASTING 888 00:31:56,098 --> 00:31:57,967 EFFECTS OF THE DISEASE, BUT I 889 00:31:57,967 --> 00:31:59,201 THINK AN AREA THAT WASN'T 890 00:31:59,201 --> 00:32:01,237 SPECIFICALLY CALLED OUT BUT -- 891 00:32:01,237 --> 00:32:03,205 BECAUSE IT'S MAYBE LESS SPECIFIC 892 00:32:03,205 --> 00:32:04,740 TO ENTERAL FEEDING BUT I THINK 893 00:32:04,740 --> 00:32:06,175 AN IMPORTANT AREA FOR 894 00:32:06,175 --> 00:32:14,717 UNDERSTANDING. 895 00:32:14,717 --> 00:32:17,019 >> CAN YOU ALL HEAR ME OKAY? 896 00:32:17,019 --> 00:32:20,623 THANK YOU FOR THE LOVELY 897 00:32:20,623 --> 00:32:21,290 PRESENTATION. 898 00:32:21,290 --> 00:32:22,458 AND FOR COVERING THIS IMPORTANT 899 00:32:22,458 --> 00:32:25,761 TOPIC IN SUCH A SHORT TIME. 900 00:32:25,761 --> 00:32:26,895 I WAS PARTICULARLY ENTHUSED THAT 901 00:32:26,895 --> 00:32:28,497 YOU CALLED OUT PRETERM BIRTH AND 902 00:32:28,497 --> 00:32:29,898 THAT ONE OF THE PRIMARY, I 903 00:32:29,898 --> 00:32:31,767 THINK, WAS YOUR FIRST BULLET IN 904 00:32:31,767 --> 00:32:33,736 A WAY TO PREVENT NEC WOULD BE TO 905 00:32:33,736 --> 00:32:35,170 IDENTIFY STRATEGIES TO PREVENT 906 00:32:35,170 --> 00:32:36,272 PRETERM BIRTH. 907 00:32:36,272 --> 00:32:39,308 YOU KNOW, AS I THINK MANY FOLKS 908 00:32:39,308 --> 00:32:42,478 KNOW, THE PRIMARY PREVENTIVE 909 00:32:42,478 --> 00:32:43,746 STRATEGY WE'VE USED FOR OVER 20 910 00:32:43,746 --> 00:32:45,581 YEARS IN MATERNAL FETAL MEDICINE 911 00:32:45,581 --> 00:32:46,949 WAS RECENTLY PULLED FROM THE 912 00:32:46,949 --> 00:32:47,950 MARKET, AND WITH NOTHING TO 913 00:32:47,950 --> 00:32:49,385 REPLACE IT. 914 00:32:49,385 --> 00:32:50,586 I THINK THERE'S AN URGENT NEED 915 00:32:50,586 --> 00:32:52,554 FOR US TO IDENTIFY STRATEGIES TO 916 00:32:52,554 --> 00:32:54,723 PREVENT PRETERM BIRTH. 917 00:32:54,723 --> 00:33:02,164 IN FACT, COMING UP AT S THE 918 00:33:02,164 --> 00:33:04,900 PRESIDENT'S WORKSHOP IS GOING TO 919 00:33:04,900 --> 00:33:07,136 BE ON PRETERM BIRTH PREVENTION 920 00:33:07,136 --> 00:33:08,737 BECAUSE THERE'S SEEMINGLY BEEN A 921 00:33:08,737 --> 00:33:10,172 PAUSE IN OUR STRATEGIES AND A 922 00:33:10,172 --> 00:33:11,774 PAUSE IN THE RESEARCH AND I 923 00:33:11,774 --> 00:33:13,442 THINK WE NEED TO REINVIGORATE 924 00:33:13,442 --> 00:33:16,612 OURSELVES TO REALLY FOCUS ON 925 00:33:16,612 --> 00:33:18,180 PRETERM BIRTH AND HOW TO PREVENT 926 00:33:18,180 --> 00:33:18,881 THAT. 927 00:33:18,881 --> 00:33:20,349 SO THANK YOU FOR CALLING THAT 928 00:33:20,349 --> 00:33:20,749 OUT. 929 00:33:20,749 --> 00:33:21,917 IF THE WORKING GROUP CONTINUES 930 00:33:21,917 --> 00:33:22,985 TO MOVE FORWARD I THINK IT WOULD 931 00:33:22,985 --> 00:33:25,054 BE GREAT TO HAVE MAYBE MORE 932 00:33:25,054 --> 00:33:27,656 REPRESENTATION OF MATERNAL FETAL 933 00:33:27,656 --> 00:33:30,526 MEDICINE DOCS AND OBSTETRICIANS 934 00:33:30,526 --> 00:33:33,662 TO KIND OF HELP WITH THAT JUST 935 00:33:33,662 --> 00:33:34,997 BECAUSE IT WAS THE NUMBER ONE 936 00:33:34,997 --> 00:33:36,298 STRATEGY YOU CALLED OUT. 937 00:33:36,298 --> 00:33:38,334 >> I WAS ACTUALLY IMPRESSED BY 938 00:33:38,334 --> 00:33:39,702 HOW MUCH CURRENT FUNDING IS 939 00:33:39,702 --> 00:33:41,337 GOING INTO NEC. 940 00:33:41,337 --> 00:33:43,972 AND I'M TRYING TO UNDERSTAND OF 941 00:33:43,972 --> 00:33:48,344 THAT FUNDING HOW MUCH OF THAT 942 00:33:48,344 --> 00:33:49,545 ACTUALLY MAY BE ADDRESSING SOME 943 00:33:49,545 --> 00:33:53,449 OF THESE AREAS THAT YOU WANT TO 944 00:33:53,449 --> 00:33:56,018 ENHANCE. 945 00:33:56,018 --> 00:33:57,453 AND HOW MUCH IS REALLY LACKING. 946 00:33:57,453 --> 00:34:00,723 >> THAT'S A GOOD POINT. 947 00:34:00,723 --> 00:34:03,659 SO REGARDING THE $101 MILLION 948 00:34:03,659 --> 00:34:05,094 THAT ARE CURRENTLY BEING 949 00:34:05,094 --> 00:34:05,961 UTILIZED, WE DIDN'T HAVE A 950 00:34:05,961 --> 00:34:08,831 CHANCE TO REALLY LOOK AT THE 951 00:34:08,831 --> 00:34:09,531 PORTFOLIO, BUT THAT WOULD BE 952 00:34:09,531 --> 00:34:11,400 SOMETHING THAT WE COULD TAKE A 953 00:34:11,400 --> 00:34:13,836 LOOK AT BEFORE OUR FINAL REPORT 954 00:34:13,836 --> 00:34:15,337 TO THE SECRETARY TO UNDERSTAND 955 00:34:15,337 --> 00:34:17,339 WHAT AREAS ARE ALREADY BEING 956 00:34:17,339 --> 00:34:17,873 ADDRESSED. 957 00:34:17,873 --> 00:34:23,345 GREAT POINT. 958 00:34:23,345 --> 00:34:26,081 >> AND ALSO, ARE THERE PREMATURE 959 00:34:26,081 --> 00:34:28,050 COHORTS THAT COULD EASILY BE 960 00:34:28,050 --> 00:34:31,320 PIVOTED TO TRY TO ENHANCE THEIR 961 00:34:31,320 --> 00:34:33,622 FUNDING, YOU KNOW, TO DEVELOP AN 962 00:34:33,622 --> 00:34:35,357 ARM THAT WOULD ADDRESS THESE 963 00:34:35,357 --> 00:34:38,994 ISSUES ON NEC? 964 00:34:38,994 --> 00:34:41,597 >> RAVI, DO YOU KNOW OF ANY 965 00:34:41,597 --> 00:34:42,931 EXISTING PREMATURE COHORTS OR 966 00:34:42,931 --> 00:34:45,334 COHORTS THAT ARE ENROLLING 967 00:34:45,334 --> 00:34:48,237 INFANTS AT RISK? 968 00:34:48,237 --> 00:34:51,540 >> THERE'S ONGOING WORK BY 969 00:34:51,540 --> 00:34:53,642 GROUPS LOOKING AT AND DEVELOPING 970 00:34:53,642 --> 00:34:56,145 A BIOREPOSITORY ACROSS A KIND OF 971 00:34:56,145 --> 00:34:57,613 SELECT NUMBER OF CENTERS LED BY 972 00:34:57,613 --> 00:35:00,849 ONE OF THE PRESENTERS OF THE 973 00:35:00,849 --> 00:35:03,018 WORKING GROUP, MISTY GOOD. 974 00:35:03,018 --> 00:35:05,220 THE NEONATAL RESEARCH NETWORK 975 00:35:05,220 --> 00:35:06,755 ENROLLS A NUMBER OF COHORTS THAT 976 00:35:06,755 --> 00:35:08,290 INVOLVE THE MOST IMMATURE 977 00:35:08,290 --> 00:35:11,693 INFANTS AND COLLECTS 978 00:35:11,693 --> 00:35:13,429 EPIDEMIOLOGIC DATA ROUTINELY 979 00:35:13,429 --> 00:35:15,297 ACROSS 15 PARTICIPATING CENTERS, 980 00:35:15,297 --> 00:35:17,232 THAT THAT'S PART OF NICHD ACROSS 981 00:35:17,232 --> 00:35:19,234 THE U.S. THAT DO COLLECT IT, BUT 982 00:35:19,234 --> 00:35:21,403 THAT COHORT IS, I THINK, MORE 983 00:35:21,403 --> 00:35:22,838 BROAD AND COULD BE ENHANCED WITH 984 00:35:22,838 --> 00:35:27,309 MORE SPECIFIC MEASURES IF THAT 985 00:35:27,309 --> 00:35:36,952 WAS A PROCESS THAT WENT FORWARD. 986 00:35:36,952 --> 00:35:38,720 >> THANK YOU FOR THIS GREAT 987 00:35:38,720 --> 00:35:39,455 PRESENTATION AND THE WORK. 988 00:35:39,455 --> 00:35:40,823 MY QUESTION IS RELATED TO THE 989 00:35:40,823 --> 00:35:43,425 IMPACT OF CO-OCCURRING OTHER 990 00:35:43,425 --> 00:35:46,929 MORBIDITIES THAT AFFECT PRETERM 991 00:35:46,929 --> 00:35:49,097 INFANTS AND HOW THOSE ARE 992 00:35:49,097 --> 00:35:51,600 TREATED, AND THE IMPACT OF THAT 993 00:35:51,600 --> 00:35:52,401 ON NEC. 994 00:35:52,401 --> 00:35:54,903 HOW WILL THAT BE INTEGRATED IN 995 00:35:54,903 --> 00:35:59,608 YOUR RECOMMENDATIONS? 996 00:35:59,608 --> 00:36:02,211 >> THAT'S A GREAT COMMENT AROUND 997 00:36:02,211 --> 00:36:03,812 WHAT ARE COFACTORS AND WHAT DO 998 00:36:03,812 --> 00:36:05,180 WE KNOW ABOUT THE COFACTORS. 999 00:36:05,180 --> 00:36:09,985 ONE OF THE AREAS THAT WE 1000 00:36:09,985 --> 00:36:10,652 DISCUSSED, PARTICULARLY AT ONE 1001 00:36:10,652 --> 00:36:19,294 OF THE MEETINGS -- 1002 00:36:19,294 --> 00:36:22,331 >> DR. MALDONADO, I THINK WE 1003 00:36:22,331 --> 00:36:25,334 LOST YOUR AUDIO. 1004 00:36:25,334 --> 00:36:27,369 >> CAN YOU HEAR ME, RAVI? 1005 00:36:27,369 --> 00:36:27,803 >> YEP. 1006 00:36:27,803 --> 00:36:29,037 >> OKAY. 1007 00:36:29,037 --> 00:36:32,641 SO JUST LOOKING AT ATTRIBUTABLE 1008 00:36:32,641 --> 00:36:34,076 FACTORS, SO GIVEN UNDERLYING 1009 00:36:34,076 --> 00:36:35,377 CONDITIONS, HOW MUCH DO THEY 1010 00:36:35,377 --> 00:36:36,678 WEIGH IN ON RISK FOR NEC. 1011 00:36:36,678 --> 00:36:39,081 AND I THINK THAT GOES BACK TO 1012 00:36:39,081 --> 00:36:41,283 DR. BARKIN'S QUESTION AS WELL 1013 00:36:41,283 --> 00:36:43,585 AROUND WHAT DO KIDS HAVE THAT 1014 00:36:43,585 --> 00:36:45,754 DEVELOP NEC VERSUS THOSE WHO 1015 00:36:45,754 --> 00:36:46,522 DON'T. 1016 00:36:46,522 --> 00:36:48,390 SO LOOKING MORE DEEPLY AT THAT. 1017 00:36:48,390 --> 00:36:50,259 I DON'T KNOW, RAVI, HAVE YOU IF 1018 00:36:50,259 --> 00:36:50,526 COMMENTS. 1019 00:36:50,526 --> 00:36:52,094 >> THERE HAS BEEN SOME WORK, 1020 00:36:52,094 --> 00:36:53,695 BABIES WHO DEVELOP PARTICULARLY 1021 00:36:53,695 --> 00:36:54,963 REQUIRE SURGERY FOR NEC HAVE A 1022 00:36:54,963 --> 00:36:59,201 HIGH RISK OF NEURODEVELOPMENTAL 1023 00:36:59,201 --> 00:37:00,736 IMPAIRMENT, RISK OF CEREBRAL 1024 00:37:00,736 --> 00:37:02,037 PALSY, AND THAT RISK MIGHT BE 1025 00:37:02,037 --> 00:37:02,604 INCREASING. 1026 00:37:02,604 --> 00:37:03,472 THERE HAS BEEN WORK AT 1027 00:37:03,472 --> 00:37:05,440 UNDERSTANDING THE MECHANISM OF 1028 00:37:05,440 --> 00:37:08,076 GUT INJURY RELATED TO BRAIN AND 1029 00:37:08,076 --> 00:37:09,611 SPECIFIC TARGETS THAT MIGHT BE 1030 00:37:09,611 --> 00:37:10,379 OPPORTUNITIES FOR THERAPY, AND 1031 00:37:10,379 --> 00:37:11,480 THERE ARE A COUPLE OF GROUPS 1032 00:37:11,480 --> 00:37:12,881 THAT ARE WORKING ON THOSE AREAS 1033 00:37:12,881 --> 00:37:15,217 TO TRY TO MINIMIZE SOME OF THE 1034 00:37:15,217 --> 00:37:16,084 NEC-ASSOCIATED MORBIDITY AMONG 1035 00:37:16,084 --> 00:37:17,319 THOSE WHO DEVELOP DISEASE. 1036 00:37:17,319 --> 00:37:18,787 OF COURSE THE BEST WAY TO 1037 00:37:18,787 --> 00:37:20,122 PREVENT THAT MORBIDITY IS TO 1038 00:37:20,122 --> 00:37:22,090 PREVENT NEC OR TO REDUCE THE 1039 00:37:22,090 --> 00:37:23,492 SEVERITY INITIALLY, BUT ONCE 1040 00:37:23,492 --> 00:37:27,329 BABIES DEVELOP IT OR REQUIRE 1041 00:37:27,329 --> 00:37:28,764 SURGERY, I THINK THERE'S EFFORT 1042 00:37:28,764 --> 00:37:29,965 TO TRY TO DETERMINE SOME OF THE 1043 00:37:29,965 --> 00:37:31,300 PATHWAYS THAT MIGHT BE 1044 00:37:31,300 --> 00:37:33,268 RESPONSIBLE FOR BRAIN INJURY AND 1045 00:37:33,268 --> 00:37:36,104 CEREBRAL PALSY FROM THE DEGREE 1046 00:37:36,104 --> 00:37:37,873 OF GUT INJURY AND INFLAMMATION 1047 00:37:37,873 --> 00:37:42,678 THAT GOES ON. 1048 00:37:42,678 --> 00:37:45,948 >> I HAD A QUESTION ACTUALLY, A 1049 00:37:45,948 --> 00:37:46,415 SCIENTIFIC QUESTION. 1050 00:37:46,415 --> 00:37:49,017 I WAS ABLE TO ATTEND TWO OF THE 1051 00:37:49,017 --> 00:37:50,118 THREE MEETINGS, SO MAYBE THIS 1052 00:37:50,118 --> 00:37:53,522 WAS DISCUSSED IN THE THIRD. 1053 00:37:53,522 --> 00:37:56,358 BUT AS WE KNOW, THERE ARE 1054 00:37:56,358 --> 00:37:58,660 MATERNAL CELLS IN BREAST MILK. 1055 00:37:58,660 --> 00:38:01,263 AND THEY PLAY A ROLE IN 1056 00:38:01,263 --> 00:38:02,731 EDUCATING THE INFANTS' IMMUNE 1057 00:38:02,731 --> 00:38:05,334 SYSTEM. 1058 00:38:05,334 --> 00:38:07,135 SO DID ANYBODY BRING UP THE 1059 00:38:07,135 --> 00:38:08,704 ISSUE OF CELLS IN BREAST MITT 1060 00:38:08,704 --> 00:38:10,505 BEING AND WHAT COULD BE THE 1061 00:38:10,505 --> 00:38:11,673 CONSEQUENCES OF GIVEN FOREIGN 1062 00:38:11,673 --> 00:38:13,642 CELLS IN BREAST MILK VIA DONOR 1063 00:38:13,642 --> 00:38:16,812 MILK? 1064 00:38:16,812 --> 00:38:19,748 >> I DON'T RECALL THAT THAT CAME 1065 00:38:19,748 --> 00:38:20,415 UP IN THE CONVERSATION. 1066 00:38:20,415 --> 00:38:22,150 DO YOU RECALL IT, RAVI, IF THAT 1067 00:38:22,150 --> 00:38:23,051 WAS ADDRESSED? 1068 00:38:23,051 --> 00:38:25,587 >> NO, THE CELLS SPECIFICALLY 1069 00:38:25,587 --> 00:38:26,655 WEREN'T TALKED ABOUT. 1070 00:38:26,655 --> 00:38:29,191 THERE WERE DISCUSSIONS FROM -- 1071 00:38:29,191 --> 00:38:30,926 ON KIND OF A HUMAN MILK SIGH 1072 00:38:30,926 --> 00:38:34,196 EBBS ASPECT ABOUT SPECIFIC -- 1073 00:38:34,196 --> 00:38:35,130 VARIABILITY IN SPECIFIC 1074 00:38:35,130 --> 00:38:38,367 COMPONENTS IN MILK, A HUMAN MILK 1075 00:38:38,367 --> 00:38:38,934 OLIGOSACCHARIDE THAT'S NOT 1076 00:38:38,934 --> 00:38:40,335 PRESENT IN ALL LACTATING PEOPLE, 1077 00:38:40,335 --> 00:38:42,504 AND THAT THAT AMOUNT OR 1078 00:38:42,504 --> 00:38:44,272 ABUNDANCE OF THAT SPECIFICALLY 1079 00:38:44,272 --> 00:38:46,575 COMPONENT MIGHT VARY IN, FOR 1080 00:38:46,575 --> 00:38:48,110 EXAMPLE, DONATED MILK, SO THAT 1081 00:38:48,110 --> 00:38:51,613 WAS DISCUSSED BUT NOT 1082 00:38:51,613 --> 00:38:52,247 SPECIFICALLY CELLS AND WHETHER 1083 00:38:52,247 --> 00:38:54,049 THAT'S AN IMPACT OR DIFFERENTIAL 1084 00:38:54,049 --> 00:38:55,450 BETWEEN DONATED MILK AND MILK 1085 00:38:55,450 --> 00:38:58,086 FROM A PARENT. 1086 00:38:58,086 --> 00:39:00,589 >> I WILL SAY ONE OF THE OTHER 1087 00:39:00,589 --> 00:39:01,156 AREAS -- SORRY. 1088 00:39:01,156 --> 00:39:03,025 ONE OF THE OTHER AREAS THAT WAS 1089 00:39:03,025 --> 00:39:04,860 REALLY -- THAT'S ALWAYS BEEN 1090 00:39:04,860 --> 00:39:07,062 REALLY STRIKING ABOUT NEC IS 1091 00:39:07,062 --> 00:39:09,164 THAT IT DOES HAVE A FAIRLY 1092 00:39:09,164 --> 00:39:12,401 TIME-LIMITED PERIOD OF RISK, SO 1093 00:39:12,401 --> 00:39:14,069 TO THE EXTENT THERE'S AN 1094 00:39:14,069 --> 00:39:18,573 EVOLVING GUT MAYBE WITH MATERNAL 1095 00:39:18,573 --> 00:39:21,209 CELLS, ON THEGENIC ISSUES AROUND 1096 00:39:21,209 --> 00:39:24,479 INFANT GUT IMMUNITY, ALL OF 1097 00:39:24,479 --> 00:39:26,314 THOSE FACTORS SEEM TO PLAY A 1098 00:39:26,314 --> 00:39:29,184 ROLE IN VERY CRITICAL EARLY 1099 00:39:29,184 --> 00:39:30,719 PERIOD IN THE PRETERM INFANT BUT 1100 00:39:30,719 --> 00:39:35,957 ALSO SOME CASES IN THE -- SO 1101 00:39:35,957 --> 00:39:39,561 THOSE ARE AREAS OF INTEREST AS 1102 00:39:39,561 --> 00:39:49,104 WELL. 1103 00:39:49,104 --> 00:39:50,639 >> I'M JUST TRYING TO 1104 00:39:50,639 --> 00:39:51,606 UNDERSTAND, AGAIN, A LITTLE BIT 1105 00:39:51,606 --> 00:39:54,142 MORE, BECAUSE I THINK THAT GOES 1106 00:39:54,142 --> 00:39:56,445 BACK TO MARCEL'S QUESTION ABOUT 1107 00:39:56,445 --> 00:39:58,013 UNDERSTANDING KIND OF WHAT'S IN 1108 00:39:58,013 --> 00:40:00,048 MATERNAL MILK VERSUS WHAT'S IN 1109 00:40:00,048 --> 00:40:01,149 FORMULA, AND JUST KIND OF TRYING 1110 00:40:01,149 --> 00:40:02,384 TO UNDERSTAND SOME OF THOSE 1111 00:40:02,384 --> 00:40:06,755 DIFFERENCES AS A WAY TO HELP US 1112 00:40:06,755 --> 00:40:08,290 IDENTIFY FACTORS. 1113 00:40:08,290 --> 00:40:12,360 WHEN USING DONOR MILK, DO YOU 1114 00:40:12,360 --> 00:40:13,862 SEE DIFFERENCES IN TERMS OF 1115 00:40:13,862 --> 00:40:14,396 BENEFIT? 1116 00:40:14,396 --> 00:40:16,732 SO IF YOU'RE USING FROZEN 1117 00:40:16,732 --> 00:40:24,606 SLOBODAN MILOSEVIMILKVERSUS FREE 1118 00:40:24,606 --> 00:40:24,906 DIFFERENCES? 1119 00:40:24,906 --> 00:40:28,009 >> I'LL LET RAVI EXPAND MORE BUT 1120 00:40:28,009 --> 00:40:30,746 SO IN STUDIES WHERE PARENTS' 1121 00:40:30,746 --> 00:40:34,816 MILK VERSUS DONOR MILK VERSUS 1122 00:40:34,816 --> 00:40:36,985 FORMULA, THERE IS A DIFFERENCE, 1123 00:40:36,985 --> 00:40:38,854 THERE'S A STATISTICALLY 1124 00:40:38,854 --> 00:40:39,521 SIGNIFICANT DIFFERENCE BETWEEN 1125 00:40:39,521 --> 00:40:41,256 GIVING DONOR MILK, SO THERE'S A 1126 00:40:41,256 --> 00:40:42,624 BENEFIT TO DONOR MILK COMPARED 1127 00:40:42,624 --> 00:40:43,625 TO FORMULA. 1128 00:40:43,625 --> 00:40:47,629 I DON'T KNOW, RAVI, IF YOU HAVE 1129 00:40:47,629 --> 00:40:49,898 ANY FURTHER -- 1130 00:40:49,898 --> 00:40:51,133 >> THERE WERE SOME DISCUSSIONS 1131 00:40:51,133 --> 00:40:53,101 AND PRESENTATIONS ON KIND OF THE 1132 00:40:53,101 --> 00:40:54,536 DIFFERENCES BETWEEN PARENTS' OWN 1133 00:40:54,536 --> 00:40:56,204 MILK AND DONOR MILK BECAUSE 1134 00:40:56,204 --> 00:40:57,706 DONOR MILK GOES THROUGH 1135 00:40:57,706 --> 00:40:59,241 PASTEURIZATION THAT ALTERS SOME 1136 00:40:59,241 --> 00:41:01,343 OF THE FOR EXAMPLE SOME OF THE 1137 00:41:01,343 --> 00:41:02,110 MICROBIOME GETS CHANGED AND 1138 00:41:02,110 --> 00:41:02,978 THERE'S SOME OTHER COMPONENTS 1139 00:41:02,978 --> 00:41:08,016 THAT ARE ALTERED WHEREAS OTHERS 1140 00:41:08,016 --> 00:41:09,684 PRESERVE, THERE'S STILL A 1141 00:41:09,684 --> 00:41:10,118 PROTECTIVE EFFECT. 1142 00:41:10,118 --> 00:41:12,621 IN TERMS OF FREEZING AND 1143 00:41:12,621 --> 00:41:13,822 PROCESSING, THAT ALSO MIGHT HAVE 1144 00:41:13,822 --> 00:41:15,157 SOME ALTERATIONS. 1145 00:41:15,157 --> 00:41:16,591 THERE HAVEN'T -- YOU KNOW, 1146 00:41:16,591 --> 00:41:20,529 BECAUSE OUR GOAL IS FOR FEEDING 1147 00:41:20,529 --> 00:41:22,497 A PARENTS' ONLY MILK WHEN 1148 00:41:22,497 --> 00:41:25,700 POSSIBLE, THERE'S NOT BEEN ANY 1149 00:41:25,700 --> 00:41:26,802 CLINICAL COMPARATIVE TRIALS 1150 00:41:26,802 --> 00:41:28,837 AGAINST DONOR MILK AND PARENTS' 1151 00:41:28,837 --> 00:41:29,938 OWN MILK. 1152 00:41:29,938 --> 00:41:32,474 MOST HAVE BEEN IF THE PARENTS' 1153 00:41:32,474 --> 00:41:33,809 OWN MILK IS INSUFFICIENT. 1154 00:41:33,809 --> 00:41:35,977 THERE HAVE BEEN STUDIES 1155 00:41:35,977 --> 00:41:36,878 COMPARING PARENTS 18 OWN MILK 1156 00:41:36,878 --> 00:41:39,848 VERSUS DONOR MILK AND SOME 1157 00:41:39,848 --> 00:41:41,583 SUGGEST POTENTIAL DIFFERENCES 1158 00:41:41,583 --> 00:41:42,250 ALTHOUGH THERE'S LIMITED 1159 00:41:42,250 --> 00:41:43,218 RESEARCH IN THAT AREA OF HOW 1160 00:41:43,218 --> 00:41:45,320 THEY MIGHT IMPACT THAT, BUT 1161 00:41:45,320 --> 00:41:46,521 THERE ARE KNOWN CHANGES THAT 1162 00:41:46,521 --> 00:41:50,025 OCCUR WITH PASTEURIZATION OF 1163 00:41:50,025 --> 00:41:51,860 DONOR MILK COMPARED TO PARENTS' 1164 00:41:51,860 --> 00:41:53,428 OWN MILK THAT HAVE BEEN 1165 00:41:53,428 --> 00:41:59,701 EVALUATED AND STUDIED. 1166 00:41:59,701 --> 00:42:01,336 >> I WANTED TO COMMENT ON THE 1167 00:42:01,336 --> 00:42:01,636 SAME POINT. 1168 00:42:01,636 --> 00:42:03,305 IN THE CONVERSATIONS ON THE 1169 00:42:03,305 --> 00:42:03,972 CALLS, THERE WAS EVIDENCE 1170 00:42:03,972 --> 00:42:05,941 PRESENTED THAT RATES OF NEC WERE 1171 00:42:05,941 --> 00:42:08,009 APPROXIMATELY HALVED WHEN USING 1172 00:42:08,009 --> 00:42:09,344 HUMAN MILK VERSUS FORMULA. 1173 00:42:09,344 --> 00:42:11,446 SO THAT'S A MAJOR INSIGHT INTO, 1174 00:42:11,446 --> 00:42:14,149 I GUESS, PATHOGENESIS BY 1175 00:42:14,149 --> 00:42:14,482 IMPLICATION. 1176 00:42:14,482 --> 00:42:16,151 IT HAS PRACTICE IMPLICATIONS 1177 00:42:16,151 --> 00:42:16,818 ALTHOUGH THE GROUP WASN'T 1178 00:42:16,818 --> 00:42:18,320 SUPPOSED TO BE TALKING ABOUT 1179 00:42:18,320 --> 00:42:19,454 BEST PRACTICE. 1180 00:42:19,454 --> 00:42:21,289 I THINK WHAT HOPEFULLY WILL COME 1181 00:42:21,289 --> 00:42:23,391 ACROSS IN THE REPORT IS, HUMAN 1182 00:42:23,391 --> 00:42:25,894 MILK IS PREFERRED. 1183 00:42:25,894 --> 00:42:27,996 PARENTS' OWN MILK, I GUESS, 1184 00:42:27,996 --> 00:42:29,297 NUMBER ONE OR DONOR MILK. 1185 00:42:29,297 --> 00:42:32,033 DONOR MILK ACTUALLY SHOULD BE 1186 00:42:32,033 --> 00:42:32,300 INCREASED. 1187 00:42:32,300 --> 00:42:33,535 AND THE QUESTIONS SCIENTIFICALLY 1188 00:42:33,535 --> 00:42:35,036 ARE WHAT IS IT ABOUT HUMAN MILK 1189 00:42:35,036 --> 00:42:36,438 THAT IS PROTECTIVE, AND IT 1190 00:42:36,438 --> 00:42:37,339 REALLY HELPS TO FRAME WHERE I 1191 00:42:37,339 --> 00:42:38,874 THINK THE FURTHER RESEARCH COULD 1192 00:42:38,874 --> 00:42:40,375 GO, LOOKING FOR THOSE SPECIFIC 1193 00:42:40,375 --> 00:42:45,113 FACTORS, CELLULAR OR BIOCHEMICAL 1194 00:42:45,113 --> 00:42:48,383 IN EVEN MILK. 1195 00:42:48,383 --> 00:42:51,553 BUT IT WAS A VERY IMPRESSIVE SET 1196 00:42:51,553 --> 00:42:56,958 OF DATA WE HEARD FROM NICHD 1197 00:42:56,958 --> 00:42:59,160 NETWORK. 1198 00:42:59,160 --> 00:43:03,598 >> MAYBE AN OPPORTUNITY TO 1199 00:43:03,598 --> 00:43:06,234 UNDERSTAND HOW BEST TO PRESERVE 1200 00:43:06,234 --> 00:43:08,003 HUMAN MILK SO YOU HAVE OPTIMAL 1201 00:43:08,003 --> 00:43:08,603 EFFECTIVENESS AND BENEFIT. 1202 00:43:08,603 --> 00:43:09,971 >> THAT DISCUSSION CAME UP AS 1203 00:43:09,971 --> 00:43:11,640 WELL AND WE TRIED TO SHOWCASE IT 1204 00:43:11,640 --> 00:43:14,676 IN ONE OF THE SLIDES, BUT IT 1205 00:43:14,676 --> 00:43:16,778 BECAME CLEAR THAT THE 1206 00:43:16,778 --> 00:43:18,980 STANDARDIZING PROTOCOLS FOR 1207 00:43:18,980 --> 00:43:22,584 HANDLING STORAGE, ALL OF THE 1208 00:43:22,584 --> 00:43:23,351 OPERATIONAL ELEMENTS THAT 1209 00:43:23,351 --> 00:43:24,452 REQUIRE BANKING AND DISTRIBUTION 1210 00:43:24,452 --> 00:43:29,291 OF DONOR MILK ARE REALLY NOT 1211 00:43:29,291 --> 00:43:30,959 QUITE AS WELL DEVELOPED AS ONE 1212 00:43:30,959 --> 00:43:33,528 WOULD LIKE, AND SO THAT WAS AN 1213 00:43:33,528 --> 00:43:35,964 AREA OF OPPORTUNITY AS WELL. 1214 00:43:35,964 --> 00:43:40,001 >> SO WE'LL GO TO ENYA AND THEN 1215 00:43:40,001 --> 00:43:40,201 PEPE. 1216 00:43:40,201 --> 00:43:41,970 >> I JUST HAVE A SHORT FOLLOW-UP 1217 00:43:41,970 --> 00:43:43,638 QUESTION ON THAT, AND THAT IS 1218 00:43:43,638 --> 00:43:47,909 THE GESTATIONAL AGE AT THE TIME 1219 00:43:47,909 --> 00:43:49,544 OF DELIVERY, WHEN THE DONOR MILK 1220 00:43:49,544 --> 00:43:52,213 IS OBTAINED IS POTENTIALLY MUCH 1221 00:43:52,213 --> 00:43:54,716 MORE ADVANCED MOST OF THE TIME 1222 00:43:54,716 --> 00:43:58,753 THAN THE GESTATIONAL AGE OF THE 1223 00:43:58,753 --> 00:44:03,191 PARENT WHO PROVIDES THE MILK. 1224 00:44:03,191 --> 00:44:05,126 SO IS THAT TAKEN INTO ACCOUNT IN 1225 00:44:05,126 --> 00:44:07,329 STUDIES TO LOOK AT -- IS THERE A 1226 00:44:07,329 --> 00:44:09,097 DIFFERENCE WHEN YOU GET HUMAN 1227 00:44:09,097 --> 00:44:13,435 MILK AT 24, 25 OR BEFORE 28 1228 00:44:13,435 --> 00:44:17,439 WEEKS AND LATER ON? 1229 00:44:17,439 --> 00:44:19,941 >> RAVI, DO YOU WANT TO TAKE 1230 00:44:19,941 --> 00:44:20,208 THAT ONE? 1231 00:44:20,208 --> 00:44:21,476 >> YEAH, THAT WAS ONE OF THE 1232 00:44:21,476 --> 00:44:22,344 PRESENTATIONS THAT TOUCHED ON 1233 00:44:22,344 --> 00:44:25,213 THAT WHICH IS THE DONORS THAT 1234 00:44:25,213 --> 00:44:27,716 PROVIDE DONATED MILK VARY IN 1235 00:44:27,716 --> 00:44:29,150 GESTATIONAL AGE. 1236 00:44:29,150 --> 00:44:31,619 SOME ARE AFTER DELIVERY, INFANT 1237 00:44:31,619 --> 00:44:33,088 BORN AT TERM, SO THE NUTRITIONAL 1238 00:44:33,088 --> 00:44:34,089 CONTENT OF THAT MILK IS 1239 00:44:34,089 --> 00:44:35,991 DIFFERENT THAN, FOR EXAMPLE, THE 1240 00:44:35,991 --> 00:44:37,625 NUTRITIONAL CONTENT OF MILK FROM 1241 00:44:37,625 --> 00:44:39,260 A PARENT WHO MIGHT BE 1242 00:44:39,260 --> 00:44:40,829 IMMEDIATELY POSTPARTUM. 1243 00:44:40,829 --> 00:44:43,431 AND ALSO SOME OF THE COMPONENTS 1244 00:44:43,431 --> 00:44:45,400 DO DIFFER OVER THE WEEKS AND 1245 00:44:45,400 --> 00:44:46,835 MONTHS POSTPARTUM IN TERMS OF 1246 00:44:46,835 --> 00:44:51,639 THE CHARACTERISTICS OF THE DONOR 1247 00:44:51,639 --> 00:44:52,073 MILK. 1248 00:44:52,073 --> 00:44:53,208 THERE WAS SOME DISCUSSION ABOUT 1249 00:44:53,208 --> 00:44:54,843 BETTER UNDERSTANDING THAT TO 1250 00:44:54,843 --> 00:44:55,510 POTENTIALLY OPTIMIZE THE 1251 00:44:55,510 --> 00:44:57,946 DELIVERY OF DONOR MILK THAT 1252 00:44:57,946 --> 00:44:59,347 MIGHT MAXIMIZE ITS KIND OF 1253 00:44:59,347 --> 00:45:00,882 BENEFICIAL CONTENT OF SPECIFIC 1254 00:45:00,882 --> 00:45:04,019 COMPONENTS BY SELECTION OF 1255 00:45:04,019 --> 00:45:05,186 DONORS WITHIN, FOR EXAMPLE, A 1256 00:45:05,186 --> 00:45:06,888 CERTAIN AMOUNT OF MONTHS 1257 00:45:06,888 --> 00:45:07,789 POSTPARTUM THAT MIGHT ALLOW 1258 00:45:07,789 --> 00:45:09,958 THAT, ALTHOUGH THAT'S AN AREA 1259 00:45:09,958 --> 00:45:11,292 WHERE THERE STILL NEEDS MORE 1260 00:45:11,292 --> 00:45:12,360 DATA TO KIND OF GUIDE THAT 1261 00:45:12,360 --> 00:45:14,029 ASPECT, BUT THERE ARE 1262 00:45:14,029 --> 00:45:15,864 DIFFERENCES IN DONORS AND THOSE 1263 00:45:15,864 --> 00:45:19,834 DONORS, MANY OF THEM ARE BORN 1264 00:45:19,834 --> 00:45:21,703 AT -- DELIVERED AT TERM JETION 1265 00:45:21,703 --> 00:45:24,706 TAIGESTATION SO THE CHARACTERISS 1266 00:45:24,706 --> 00:45:26,775 OF THAT MILK IS GOING TO BE 1267 00:45:26,775 --> 00:45:28,843 DIFFERENT THAN A BABY THAT'S 1268 00:45:28,843 --> 00:45:31,046 BORN, FOR EXAMPLE, AT 24 WEEKS 1269 00:45:31,046 --> 00:45:31,312 GESTATION. 1270 00:45:31,312 --> 00:45:33,314 >> THE OTHER ISSUE THAT CAME UP 1271 00:45:33,314 --> 00:45:34,382 IS THE FACT THAT THERE ARE 1272 00:45:34,382 --> 00:45:35,817 REALLY NO POINT OF CARE 1273 00:45:35,817 --> 00:45:37,252 DIAGNOSTICS FOR DETERMINING THE 1274 00:45:37,252 --> 00:45:39,354 COMPOSITION OF MILK WHEN IT'S 1275 00:45:39,354 --> 00:45:40,889 GIVEN, SO AGAIN, WHETHER OR NOT 1276 00:45:40,889 --> 00:45:43,625 YOU CAN EVEN TRY TO MATCH 1277 00:45:43,625 --> 00:45:45,393 CHRONOLOGICAL AND GESTATIONAL 1278 00:45:45,393 --> 00:45:46,694 AGE EVEN BEYOND THAT IS JUST 1279 00:45:46,694 --> 00:45:48,563 UNDERSTANDING THE CONTENT EVEN 1280 00:45:48,563 --> 00:45:50,665 AT THE SAME CHRONOLOGICAL OR 1281 00:45:50,665 --> 00:45:51,966 GESTATIONAL AGE, THERE'S A 1282 00:45:51,966 --> 00:45:53,168 GOOD DEGREE OF VARIABILITY AMONG 1283 00:45:53,168 --> 00:45:55,603 DONORS AND IT WOULD BE -- THE 1284 00:45:55,603 --> 00:45:57,705 DIFFERENT MEMBERS OF THE GROUP 1285 00:45:57,705 --> 00:45:58,473 WORKING GROUP THOUGHT IT WOULD 1286 00:45:58,473 --> 00:46:00,642 BE HELPFUL TO HAVE RAPID 1287 00:46:00,642 --> 00:46:02,744 DIAGNOSTICS TO BE ABLE TO 1288 00:46:02,744 --> 00:46:05,680 DETERMINE THAT CONTENT AND THE 1289 00:46:05,680 --> 00:46:06,181 COMPOSITION. 1290 00:46:06,181 --> 00:46:08,550 >> WE'LL TAKE ONE LAST QUESTION. 1291 00:46:08,550 --> 00:46:09,651 >> THANK YOU. 1292 00:46:09,651 --> 00:46:11,286 SO ONE OF THE RECOMMENDATIONS 1293 00:46:11,286 --> 00:46:16,558 WAS ON HARNESSING OPEN AI AND 1294 00:46:16,558 --> 00:46:17,692 MACHINE LEARNING AND THAT MAKES 1295 00:46:17,692 --> 00:46:19,094 SENSE GIVEN THE NUMBER OF 1296 00:46:19,094 --> 00:46:23,064 STUDIES, BUT DO YOU THINK WHAT'S 1297 00:46:23,064 --> 00:46:24,132 READINESS OF THE DATASETS? 1298 00:46:24,132 --> 00:46:25,767 DO YOU THINK WE NEED SOME 1299 00:46:25,767 --> 00:46:29,204 HARMONIZING OR -- THEY NEED 1300 00:46:29,204 --> 00:46:30,405 INFRASTRUCTURE THAT NEEDS TO BE 1301 00:46:30,405 --> 00:46:33,374 DONE IF BEFORE WE GO THERE? 1302 00:46:33,374 --> 00:46:34,642 MY SECOND QUESTION IS, HOW WOULD 1303 00:46:34,642 --> 00:46:36,578 YOU PRIORITIZE AIL THESE 1304 00:46:36,578 --> 00:46:37,345 REPRESENTATIONS, OR DO WE NEED 1305 00:46:37,345 --> 00:46:38,012 TO? 1306 00:46:38,012 --> 00:46:38,880 >> GREAT POINT. 1307 00:46:38,880 --> 00:46:41,216 I DON'T KNOW, RAVI, IF YOU 1308 00:46:41,216 --> 00:46:43,818 HAVE -- WE TALKED A BIT AND I 1309 00:46:43,818 --> 00:46:48,890 KNOW WITH DAVID ROWCH AS WELL WE 1310 00:46:48,890 --> 00:46:52,260 TALKED ABOUT THE AVAILABILITY OF 1311 00:46:52,260 --> 00:46:53,461 ELECTRONIC HEALTH RECORDS 1312 00:46:53,461 --> 00:46:55,663 DATASETS AND I THINK MORE AND 1313 00:46:55,663 --> 00:46:57,098 MORE THEY ARE BECOMING 1314 00:46:57,098 --> 00:46:57,866 AVAILABLE, I DON'T KNOW 1315 00:46:57,866 --> 00:46:58,967 SPECIFICALLY FOR THIS PARTICULAR 1316 00:46:58,967 --> 00:47:03,037 INDICATION BUT CAPACITY IS BEING 1317 00:47:03,037 --> 00:47:04,906 BUILT AT A NUMBER OF 1318 00:47:04,906 --> 00:47:05,240 INSTITUTIONS. 1319 00:47:05,240 --> 00:47:05,907 THE QUESTION WOULD BE, AGAIN, 1320 00:47:05,907 --> 00:47:08,543 THE ABILITY TO HAVE THE 1321 00:47:08,543 --> 00:47:13,181 COMPUTING POWER TO BE ABLE TO 1322 00:47:13,181 --> 00:47:14,682 STORE THAT -- 1323 00:47:14,682 --> 00:47:16,551 >> I THINK THERE'S OPPORTUNITY, 1324 00:47:16,551 --> 00:47:17,852 THE CHALLENGE FOR A LOT OF THE 1325 00:47:17,852 --> 00:47:19,087 MACHINE LEARNING AND THE AI 1326 00:47:19,087 --> 00:47:21,589 MODELS IS TRAINING WHAT'S THE 1327 00:47:21,589 --> 00:47:22,490 GOLD STANDARD DEFINITION AND 1328 00:47:22,490 --> 00:47:24,125 THAT'S A LIMITATION OF KIND OF 1329 00:47:24,125 --> 00:47:26,561 WHAT YOU USE AS THE GOLD 1330 00:47:26,561 --> 00:47:27,962 STANDARD DEFINITION TO LEARN ON 1331 00:47:27,962 --> 00:47:28,530 THOSE MODELS. 1332 00:47:28,530 --> 00:47:30,098 THE OTHER CHALLENGE IS NEC CAN 1333 00:47:30,098 --> 00:47:32,167 BE AN ACUTE DISEASE THAT OFTEN 1334 00:47:32,167 --> 00:47:33,468 IS VERY SUDDEN ONSET, SO THE 1335 00:47:33,468 --> 00:47:37,972 KIND OF DOCUMENTATION FOR 1336 00:47:37,972 --> 00:47:39,207 CLINICAL SYMPTOMATOLOGY, TIME OF 1337 00:47:39,207 --> 00:47:40,842 ONSET MAY NOT BE CONSISTENT, AND 1338 00:47:40,842 --> 00:47:41,943 SO SOME OF THE FEATURES THAT 1339 00:47:41,943 --> 00:47:44,479 MIGHT BE RECORDED ON A DAILY 1340 00:47:44,479 --> 00:47:46,347 BASIS ON FOR EXAMPLE A DAILY 1341 00:47:46,347 --> 00:47:47,882 NOTE MAY NOT CAPTURE THE 1342 00:47:47,882 --> 00:47:49,083 GRANULARITY THAT MIGHT BE NEEDED 1343 00:47:49,083 --> 00:47:50,752 AT TIME OF ONSET, WHICH CAN BE 1344 00:47:50,752 --> 00:47:54,355 VERY ACUTE AND PROGRESS QUICKLY, 1345 00:47:54,355 --> 00:47:56,124 SO THERE ARE OTHER DATA IN THE 1346 00:47:56,124 --> 00:47:56,891 ELECTRONIC HEALTH RECORD THAT 1347 00:47:56,891 --> 00:47:58,760 CAN BE EXTRACTED BUT SOME OF THE 1348 00:47:58,760 --> 00:47:59,761 CLINICAL DATA IS LIMITED IN THAT 1349 00:47:59,761 --> 00:48:05,466 REGARD. 1350 00:48:05,466 --> 00:48:06,768 >> YOU ALSO MENTIONED 1351 00:48:06,768 --> 00:48:08,102 PRIORITIZING. 1352 00:48:08,102 --> 00:48:09,170 WE COULDN'T GET TO THAT POINT 1353 00:48:09,170 --> 00:48:09,337 YET. 1354 00:48:09,337 --> 00:48:10,838 I DON'T KNOW IF IN THE NEXT WEEK 1355 00:48:10,838 --> 00:48:11,973 WE'LL BE ABLE TO DO THAT. 1356 00:48:11,973 --> 00:48:14,609 IT'S A PRETTY BROAD ARRAY OF 1357 00:48:14,609 --> 00:48:16,244 QUESTIONS, BUT I THINK WE'LL 1358 00:48:16,244 --> 00:48:18,680 HAVE TO THINK ABOUT MAYBE A 1359 00:48:18,680 --> 00:48:21,182 SECOND SET OF MEETINGS TO TRY TO 1360 00:48:21,182 --> 00:48:22,617 THINK ABOUT PRIORITIZATION, BUT 1361 00:48:22,617 --> 00:48:24,385 I THINK THIS WAS AT LEAST A 1362 00:48:24,385 --> 00:48:25,687 PRELIMINARY STAB AT SOME OF THE 1363 00:48:25,687 --> 00:48:27,355 HIGH LEVEL QUESTIONS THAT 1364 00:48:27,355 --> 00:48:30,625 HAVEN'T REALLY BEEN ADDRESSED. 1365 00:48:30,625 --> 00:48:32,026 >> OKAY. 1366 00:48:32,026 --> 00:48:34,262 IN THE INTEREST OF TIME, 1367 00:48:34,262 --> 00:48:35,230 REGRETFULLY I HAVE TO LIMIT THE 1368 00:48:35,230 --> 00:48:36,664 DISCUSSION, AND AGAIN, I WANT TO 1369 00:48:36,664 --> 00:48:39,000 THANK EVERYONE INVOLVED AND THE 1370 00:48:39,000 --> 00:48:42,403 COUNCILMEMBERS FOR THEIR VERY 1371 00:48:42,403 --> 00:48:43,905 INTERESTING AND RELEVANT 1372 00:48:43,905 --> 00:48:44,672 QUESTIONS. 1373 00:48:44,672 --> 00:48:47,542 WE ARE NOW GOING TO ASK FOR A 1374 00:48:47,542 --> 00:48:48,643 MOTION FOR APPROVAL OF THE 1375 00:48:48,643 --> 00:48:49,744 WORKING GROUP'S REPORT. 1376 00:48:49,744 --> 00:48:51,946 WE'RE GOING TO DO DOUBLE DUTY 1377 00:48:51,946 --> 00:48:54,148 AND ASK YOU TO ENDORSE THE 1378 00:48:54,148 --> 00:48:55,149 RECOMMENDATIONS FOR FUTURE 1379 00:48:55,149 --> 00:48:57,018 RESEARCH. 1380 00:48:57,018 --> 00:49:01,489 SO WE'LL USE IT ALSO AS AN OPEN 1381 00:49:01,489 --> 00:49:04,325 CLEARANCE OF THE CONCEPT. 1382 00:49:04,325 --> 00:49:05,793 SO WE NEED A MOTION TO APPROVE 1383 00:49:05,793 --> 00:49:07,895 THE WORKING GROUP'S REPORT AND 1384 00:49:07,895 --> 00:49:10,498 AT THE SAME TIME, PROVIDE 1385 00:49:10,498 --> 00:49:11,466 CONCEPT CLEARANCE. 1386 00:49:11,466 --> 00:49:13,034 SO DOES SOMEONE WANT TO PROVIDE 1387 00:49:13,034 --> 00:49:14,669 A MOTION? 1388 00:49:14,669 --> 00:49:15,770 >> SO MOVED. 1389 00:49:15,770 --> 00:49:17,405 >> THANK YOU, MARCEL. 1390 00:49:17,405 --> 00:49:18,539 IS THERE A SECONDER? 1391 00:49:18,539 --> 00:49:19,173 >> SECOND. 1392 00:49:19,173 --> 00:49:22,910 >> THANK YOU, ENYA. 1393 00:49:22,910 --> 00:49:24,646 NOW WE'RE GOING TO ASK YOU TO 1394 00:49:24,646 --> 00:49:26,381 VOTE BY RAISING YOUR HANDS AND 1395 00:49:26,381 --> 00:49:27,649 THOSE -- I SEE DR. BARKIN, I 1396 00:49:27,649 --> 00:49:34,255 DON'T KNOW IF DR. -- 1397 00:49:34,255 --> 00:49:41,296 >> PROFESSOR BROOKS AND 1398 00:49:41,296 --> 00:49:44,599 DR. FAIR. 1399 00:49:44,599 --> 00:49:46,267 >> OKAY, THANK YOU VERY MUCH. 1400 00:49:46,267 --> 00:49:48,903 SO THE WORKING GROUP'S REPORT IS 1401 00:49:48,903 --> 00:49:49,170 APPROVED. 1402 00:49:49,170 --> 00:49:51,205 AGAIN, WE THANK YOU FOR YOUR 1403 00:49:51,205 --> 00:49:52,573 OUTSTANDING WORK AT THIS TIME, 1404 00:49:52,573 --> 00:49:55,043 THE OPEN SESSION IS GOING TO 1405 00:49:55,043 --> 00:49:55,310 CONCLUDE. 1406 00:49:55,310 --> 00:49:57,145 WE ARE GOING TO TAKE A 15-MINUTE 1407 00:49:57,145 --> 00:49:59,247 BREAK NOW TO SWITCH OVER TO THE 1408 00:49:59,247 --> 00:50:00,014 CLOSED SESSION. 1409 00:50:00,014 --> 00:50:02,750 I REALIZE SOME OF YOU HAVE TIGHT 1410 00:50:02,750 --> 00:50:03,951 FLIGHT CONNECTIONS, SO WE MAY 1411 00:50:03,951 --> 00:50:06,521 NEED TO SACRIFICE THE BREAK 1412 00:50:06,521 --> 00:50:07,689 LATER ON IN THE MEETING. 1413 00:50:07,689 --> 00:50:09,357 I'M VERY AWARE OF THE FACT THAT 1414 00:50:09,357 --> 00:50:10,825 PEOPLE NEED TO GET TO THE 1415 00:50:10,825 --> 00:50:11,359 AIRPORT. 1416 00:50:11,359 --> 00:50:15,263 SO LET'S TAKE A BREAK NOWM, ANDD 1417 00:50:15,263 --> 00:50:19,200 WE WILL RESUME AT 10:00.