NCT01122654已完成不适用
Growth and Tolerance of Cow Milk-Based Infant Formulas
Mead Johnson Nutrition24 个研究点 分布在 1 个国家目标入组 405 人开始时间: 2010年7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
- 405
- 试验地点
- 24
- 主要终点
- Body weight measured on calibrated infant scale at each study visit
研究概览
简要总结
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Days 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 12-16 days of age at randomization
- •Term infant with birth weight of minimum of 2500 g
- •Solely formula fed
- •Signed Informed Consent and Protected Health Information
排除标准
- •History of underlying metabolic or chronic disease or immunocompromised
- •Acute infection
- •Feeding difficulties or formula intolerance
结局指标
主要结局
Body weight measured on calibrated infant scale at each study visit
次要结局
- Twenty-four hour recall of infant formula intake at each study visit
- Medically-confirmed adverse events collected throughout the study period
- Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
- Parental Product Assessment Questionnaire completed at Study Visit 2
- Body Length and Head Circumference measured at each study visit
研究者
研究点 (24)
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