Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Any formula use at 1 week of age
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 48 Hours(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
研究组 & 干预措施
Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
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)
干预措施: Donor Milk (Other)
结局指标
主要结局
Any formula use at 1 week of age
时间窗: 1 week
Any formula intake within the last 24 hours.
次要结局
- Exclusive breastfeeding(2 months)
- Any breastfeeding(1 week)
- Any breastfeeding at 3 months(3 months)
研究者
Laura Kair
Adjunct Assistant Professor
University of Iowa
