NCT02456805已完成不适用
Efficacy of Alternate Formula Feedings in Formula Intolerant Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 16
- 主要终点
- Stool Characteristics
研究概览
简要总结
This study assessed tolerance improvement of a formula change in healthy term infants with perceived intolerance to their current milk-based formula feeding.
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
- 2 Weeks 至 9 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants formula-fed exclusively and experiencing symptoms of cow's milk formula intolerance.
- •Infants whose physicians had made a recommendation that the parents change the infant's feeding.
- •Full term infants at birth with a gestational age of 37 to 42 weeks.
- •Infants 2- 9 weeks of age at study entry with birth weights greater than 2500 grams.
排除标准
- •Infants with a maternal medical history which had adverse effects on the fetus, such as diabetes, tuberculosis, perinatal infections, or substance abuse.
- •Infants with evidence of cardiac, respiratory, gastrointestinal, hematological, or metabolic disease.
结局指标
主要结局
Stool Characteristics
时间窗: Change from Baseline (Study Day 1) to Study Day 15
Parent questionnaire
次要结局
- Weight(Change from Baseline (Study Day 1) to Study Day 15)
- Formula Intake(Change from Baseline (Study Day 1) to Study Day 15)
- Incidence of spit up/vomiting(Change from Baseline (Study Day 1) to Study Day 15)
研究者
研究点 (16)
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