NCT00936637已完成不适用
A 16-Week Growth Study of an Extensively Hydrolyzed Infant Formula, 3 Months Treatment and 1 Month Follow-up for a Duration of 4 Months.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants
研究概览
简要总结
The purpose of this study is to assess growth in infants who are fed an extensively hydrolyzed formula.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At birth:
- •Healthy, term (37-42 weeks) infant
- •Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
- •At time of enrollment:
- •< or = 21 days post-natal age
- •Weight for length between the 10th and 90th percentile according to the National Center for Health Statistics (NCHS) growth charts
- •Exclusively formula fed
- •Written informed consent of parent/guardian
排除标准
- •At the time of enrollment: partially human-milk fed; fed baby/solid foods
- •Conditions requiring feedings other than those specified in the protocol
- •Documented or suspected cow's milk allergy and/or soy protein allergies
- •Major congenital deformities
- •Suspected or documented systemic or congenital infections
- •Evidence of cardiac, respiratory, hematological, gastrointestinal, or other systemic diseases
- •Participation in any other clinical trial
结局指标
主要结局
An extensively hydrolyzed formula is nutritionally adequate for normal growth of healthy full-term infants
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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