NCT04105686已完成不适用
Growth and Tolerance of Young Infants Fed Milk-Based Infant Formula With Oligosaccharides
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 366
- 试验地点
- 64
- 主要终点
- Weight
研究概览
简要总结
This is a randomized, multicenter, controlled, double-blind, parallel study to evaluate growth and tolerance of healthy term infants fed milk-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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is judged to be in good health as determined from participant's medical history.
- •Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks.
- •Participant's birth weight was > 2490 g (~5 lbs. 8 oz.).
- •Parent(s) who elect to formula-feed the participant, confirm their intention to feed their infant the study product as the sole source of feeding during the study.
- •Parent(s) who elect to feed the participant human milk, confirm their intention to exclusively feed human milk as the sole source of feeding during the study.
- •Parent(s) of formula-fed infants confirm their intention not to administer vitamin or mineral supplements, (except for vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- •Parent(s) of human milk-fed infants confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study (vitamins and minerals are acceptable).
- •Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or applicable privacy regulation) authorization prior to any participation in the study.
排除标准
- •An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- •Participant is taking and plans to continue taking medications (including over the counter), prebiotics, probiotics, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance.
- •Participant participates in another study that has not been approved as a concomitant study.
结局指标
主要结局
Weight
时间窗: Day of life 14 to Day of life 119
Weight gain per day
次要结局
- Stool Characteristics(Study Day 1 to Day of life 119)
- Head Circumference (HC)(Day of life 14 to Day of life 119)
- Length(Day of life 14 to Day of life 119)
- Formula Tolerance(Study Day 1 to Day of life 119)
研究者
研究点 (64)
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