NCT02132663已完成不适用
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
Mead Johnson Nutrition44 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2014年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 44
- 主要终点
- Body weight measured at each study visit
研究概览
简要总结
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
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
- 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
- •History of underlying metabolic or chronic disease or immunocompromised
- •Feeding difficulties or formula intolerance
研究组 & 干预措施
Infant formula containing an alternate source of DHA
Experimental
干预措施: An investigational infant formula containing an alternate source of DHA (Other)
Marketed routine infant formula
Active Comparator
干预措施: Control: Marketed routine infant formula (Other)
结局指标
主要结局
Body weight measured at each study visit
时间窗: 3.5 Months
次要结局
- Body length measured at each study visit(3.5 months)
- Recall of stool consistency measured at each study visit(3.5 months)
- Recall of gastrointestinal tolerance measured at each study visit(3.5 months)
- Blood Collection(Once at 120 days of age)
- Medically-confirmed adverse events collected throughout the study period(3.5 months)
- Head circumference measured at each study visit(3.5 months)
- Recall of infant formula intake at each study visit(3.5 months)
研究者
研究点 (44)
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