NCT00984230已完成不适用
A New Adaptive Feeding Plan for Newborns: Effects on Gut Maturity and Gut Microbiota
Société des Produits Nestlé (SPN)12 个研究点 分布在 3 个国家目标入组 186 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 186
- 试验地点
- 12
- 主要终点
- gut maturation : Specific proteins in stools
研究概览
简要总结
The purpose of this clinical trial is to identify the infant formula(s) for which the investigators get the closest gut maturation index compared to the one they get with breastfed babies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy newborn infant
- •Full term infant (≥ 37 weeks gestation; < 42 weeks gestation)
- •Birth weight from 2500g to 4500g
- •For the formula-fed groups: babies whose mothers elected not to breastfeed at all
- •For the breastfed group: babies whose mothers elected to exclusively breastfeed for at least 2 months
- •Newborn whose parents / caregivers can be expected to comply with the protocol
- •Study explained and written information given
- •Informed consent signed
排除标准
- •Mother who had antibiotics in the 7 days preceding delivery
- •Caesarian section
- •Multiple birth
- •Congenital illness or malformation that may affect normal growth
- •Significant pre-natal and/or post-natal disease
- •Newborn participating in another clinical trial
结局指标
主要结局
gut maturation : Specific proteins in stools
时间窗: 3rd day, at 1 week, 2 weeks and 1 month of age
次要结局
- Growth and gut microbiota(At 1 month and 2 months)
研究者
研究点 (12)
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