NCT01380886已完成3 期
Growth and Tolerance of Young Infants Fed Infant Formulas
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 209
- 试验地点
- 12
- 主要终点
- Weight gain
研究概览
简要总结
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 8 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy infant
- •full term
- •birth weight > 2490 g
- •0 to 8 days of age
- •parent/physician agree to not use medications affecting tolerance/growth
- •parent agrees to sole source feeding of study formula
- •parent agrees to not use vitamin/mineral supplements
- •parent has signed consent/HIPAA authorization
排除标准
- •any maternal, fetal, or infant history affecting growth and tolerance
- •participation in any other study not preapproved by Abbott
研究组 & 干预措施
Infant formula, alternate protein source
Experimental
Experimental infant formula with alternate protein source
干预措施: experimental infant formula with alternate protein source (Other)
Infant formula powder
Active Comparator
Infant formula powder
干预措施: Infant formula powder (Other)
结局指标
主要结局
Weight gain
时间窗: 119 days
次要结局
- gastrointestinal tolerance(119 days)
- Anthropometric variables(119 days)
研究者
研究点 (12)
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