- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02221167
Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes (Rx Milk)
Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population.
We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Children's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Gestational age greater than or equal to 37 weeks
- Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
- Chronologic age of 24-48 hours old at the time of study enrollment
Exclusion Criteria:
- twins and higher level multiples
- infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
- mother incarcerated
- mother's age <18 years
- mother reports mature milk production prior to study enrollment
- mother does not speak English
- infants offered > 1 supplemental feeding of formula or donor milk
- weight loss greater than 10%
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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간섭 없음: Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
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활성 비교기: Donor Milk
Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II)
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breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Any formula use at 1 week of age
기간: 1 week
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Any formula intake within the last 24 hours.
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1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exclusive breastfeeding
기간: 3 months
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Infants receiving breast milk and no formula in the last 24 hours.
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3 months
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Any breastfeeding at 3 months
기간: 3 months
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Infants receiving some breast milk in addition to some formula in the last 24 hours.
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3 months
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Any breastfeeding
기간: 1 month
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1 month
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Exclusive breastfeeding
기간: 1 month
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1 month
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Exclusive breastfeeding
기간: 2 months
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2 months
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Any breastfeeding
기간: 2 months
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2 months
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Any breastfeeding
기간: 1 week
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1 week
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Laura R Kair, MD, University of Iowa
- 연구 책임자: Tarah T Colaizy, MD, MPH, University of Iowa
- 연구 책임자: Valerie J Flaherman, MD, MPH, University of California, San Francisco
간행물 및 유용한 링크
일반 간행물
- Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.
- Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.
- Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.
- Kair LR, Flaherman VJ, Colaizy TT. Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Clin Pediatr (Phila). 2019 May;58(5):534-540. doi: 10.1177/0009922819826105. Epub 2019 Jan 28.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .