Effect of Early Limited Formula Use on Breastfeeding Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Is infant receiving exclusively breast milk at 8 days of life?
研究概览
简要总结
The aim of this study is to conduct a pilot randomized controlled trial of the effect of early limited formula supplementation on breastfeeding-related outcomes for infants with high early weight loss. The investigators will enroll 40 exclusively breastfeeding infants at 24-48 hours of age and will randomly assign them to early limited formula supplementation following nursing (intervention group) or to no formula feeding (control group). Both groups will receive intensive lactation support. Outcome variables will include breastfeeding status on day-of-life 8, weight nadir, breastfeeding self-efficacy, maternal satisfaction, and exclusive and partial breastfeeding at 1-3 months. The hypothesis for this study is that early limited formula supplementation might help infants with early weight loss avoid eventual weight loss ≥ 10% and associated breastfeeding problems.
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
- 是
入选标准
- •Healthy term infants (37 to 42 weeks gestation)
- •Infants who have lost 5% of their birth weight at <36 hours of age
排除标准
- •Infants who have received formula or water
- •Mothers who are producing mature milk supply
- •Infants receiving Level II or Level III care other than healthy term infants with routine complete blood count and blood tests pending
结局指标
主要结局
Is infant receiving exclusively breast milk at 8 days of life?
时间窗: 8 days following baseline
次要结局
- Is infant receiving exclusive or partial breastfeeding at 1 month, 2 months, and 3 months?(1-3 months following baseline)