NCT02481531已完成不适用
Growth and Tolerance of Cow's Milk-Based Infant Formulas
Mead Johnson Nutrition42 个研究点 分布在 1 个国家目标入组 373 人开始时间: 2015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
- 373
- 试验地点
- 42
- 主要终点
- Body weight measured at each study visit
研究概览
简要总结
This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed 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
- 10 Days 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton, 10-14 days of age at randomization
- •Term infant with birth weight of a minimum of 2500 grams
- •Solely formula fed
- •Signed Informed Consent and Protected Health Information
排除标准
- •Anemia at time of birth
- •Current use of iron or iron-containing supplements
- •History of underlying metabolic or chronic disease or immunocompromised
- •Feeding difficulties or formula intolerance
结局指标
主要结局
Body weight measured at each study visit
时间窗: 12 months
Measurement collected with a calibrated infant scale
次要结局
- Body length measured at each study visit(12 months)
- Head circumference measured at each study visit(12 months)
- Parental recall of study formula intake at each study visit(12 months)
- Parental recall of stool consistency measured at each study visit(12 months)
- Blood Collection(Once at 12 months)
- Medically-confirmed adverse events collected throughout the study period(12 months)
研究者
研究点 (42)
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