NCT00666120已完成不适用
Assessment of Feeding Tolerance in Infants Fed Cow Milk Formula
Mead Johnson Nutrition36 个研究点 分布在 1 个国家目标入组 333 人开始时间: 2005年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 333
- 试验地点
- 36
- 主要终点
- Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
研究概览
简要总结
To compare the number of infants who discontinue from study formula due to formula intolerance as documented by the investigator.
Hypothesize there will be no difference between formula groups.
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
- 4 Days 至 18 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton birth
- •Term infant at birth
- •Birth weight of 2500 g (5 lbs 8 oz) or more
- •4 - 18 days of age at Study Visit 1
排除标准
- •History of underlying metabolic or chronic disease or congenital malformation
- •Infant switched formulas more than one time between birth and Study Visit 1
- •Known feeding problems at Study Visit 1
结局指标
主要结局
Number of infants who discontinue from study formula due to formula intolerance as documented by the investigator
时间窗: 60 days
次要结局
- Infant temperament(60 days)
研究者
研究点 (36)
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