At-the-Breast vs. Expressed Human Milk: Genesis of Infant Nutrition (BEGIN)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Infant Sleep Latency
研究概览
简要总结
The purpose of this study is to define human milk (HM) as an ecosystem which investigators will then combine into temporal models of milk dynamics to accurately describe HM chronobiology. This study addresses 4 crucial public health gaps: 1) how breast milk changes over time and over the day, 2) how milk dynamics are related to infant sleep patterns, 3) how milk dynamics are related to infant microbiome dynamics, and 4) how all these relationships differ between infants fed directly at-the-breast vs pumped milk. These fundamental insights have been unknown until now, so that families who feed pumped breast milk are completely underserved. These results are critical to optimizing infant feeding and health outcomes for all infants receiving breast milk.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lactating mothers between 20-40 years old at enrollment
- •o 120 mother/infant dyads who primarily feed HM ATB (average >75% of feeds,
- •pumping no more than one time per day)
- •o 120 mother/infant dyads who predominantly feed expressed HM (average >75% of feeds)
- •All races and ethnicities may enroll
- •Singleton infant delivered after 37 weeks
- •Infant between the ages of 0-1 months at the time of enrollment.
- •No serious health complications in mother or infant
排除标准
- •Non-English-speaking subjects as study personnel only speak English
- •Lactating moms who will be feeding both ATB and expressed HM (over 25% of the time in either feeding mode)
- •Infant supplementation with formula ≥10 oz before sample collections begin, and/or no more than 16 oz during active participation/ sample collections.
结局指标
主要结局
Infant Sleep Latency
时间窗: Baseline, 2 months and 4 months
The time to fall asleep after bedtime(minutes)
次要结局
未报告次要终点
研究者
Bridget Young
Associate Professor of Pediatrics
University of Rochester