NCT03276884已完成不适用
Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 44
- 主要终点
- Weight Gain
研究概览
简要总结
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is judged to be in good health.
- •Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- •Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- •Subject is between 0 and 8 days of age at enrollment.
- •Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- •Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
- •Subject participates in another study that has not been approved as a concomitant study.
研究组 & 干预措施
Experimental Infant Formula
Experimental
Infant formula powder to be fed ad libitum
干预措施: Experimental Infant Formula (Other)
Control Infant Formula
Active Comparator
Infant formula powder to be fed ad libitum
干预措施: Control Infant Formula (Other)
结局指标
主要结局
Weight Gain
时间窗: Study Day 14 to Study Day 119
Infant scale
次要结局
- GI tolerance(Study Day 1 to Study Day 119)
- Length(Study Day 1 to Study Day 119)
- Head Circumference(Study Day 1 to Study Day 119)
- Weight(Study Day 1 to Study Day 119)
研究者
研究点 (44)
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