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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Children's Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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%
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし:Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
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アクティブコンパレータ: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."
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Any formula use at 1 week of age
時間枠:1 week
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Any formula intake within the last 24 hours.
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1 week
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exclusive breastfeeding
時間枠: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
時間枠: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
時間枠:1 month
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1 month
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Exclusive breastfeeding
時間枠:1 month
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1 month
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Exclusive breastfeeding
時間枠:2 months
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2 months
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Any breastfeeding
時間枠:2 months
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2 months
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Any breastfeeding
時間枠:1 week
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1 week
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Laura R Kair, MD、University of Iowa
- スタディディレクター:Tarah T Colaizy, MD, MPH、University of Iowa
- スタディディレクター:Valerie J Flaherman, MD, MPH、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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