NCT03967132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
- 189
- 试验地点
- 38
- 主要终点
- Weight
研究概览
简要总结
The purpose of this study is to evaluate growth and tolerance of healthy term infants fed an experimental milk-based infant formula with oligosaccharides compared to a control milk-based infant formula.
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
- •Good health as determined from participant's medical history
- •Singleton from a full-term birth with a gestational age of 37-42 weeks
- •Birth weight was > 2490 g (~5 lbs. 8 oz.)
- •If parent(s) of the participant elect to formula-feed the participant, parent(s) confirm the participant has not been given human milk since being discharged from the hospital following birth, and confirm their intention to feed their infant the study product as the sole source of feeding from Study Visit 1-Visit 7, unless instructed otherwise by their healthcare professional.
- •If parent(s) of the participant elect to feed the infant human milk, they confirm the infant has not received any formula prior to enrollment, and confirm their intention to exclusively feed human milk from birth, and as the sole source of feeding from Study Visit 1-Visit
- •Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional.
- •Participant's parent(s) has voluntarily signed and dated an ICF, approved by an IRB/IEC and provided HIPAA (or other 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 (OTC), such as Mylicon® for gas), prebiotics, probiotics, home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance.
- •Participant participates in another study that has not been approved as a concomitant study by AN.
结局指标
主要结局
Weight
时间窗: Day of life 14 - 119
Weight gain per day
次要结局
- Length(Study Day 1 to Day of life 119)
- Head Circumference (HC)(Study Day 1 to Day of life 119)
- Stool Characteristics(Study Day 1 to Day of life 119)
- Illness Incidence(Study Day 1 to Day of life 119)
- Formula Tolerance(Study Day 1 to Day of life 119)
研究者
研究点 (38)
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