NCT01137877终止3 期
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 399
- 试验地点
- 40
- 主要终点
- weight gain
研究概览
简要总结
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 11 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in good health
- •singleton full term birth
- •Birth weight > 2490 g.
- •Infant is between 0 and 11 days of age
- •Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
- •If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- •If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
- •not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study
排除标准
- •adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
结局指标
主要结局
weight gain
时间窗: 14 to 119 days of age
次要结局
- GI tolerance(14 to 119 days of age)
- anthropometrics(14 to 119 days of age)
研究者
研究点 (40)
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