NCT05947084已完成不适用
Comparison of Growth and Tolerance of Healthy Term Infants Fed Iron-Fortified Infant Formulas. A 4 Month, Prospective, Randomized, Multi Center Clinical Trial.
Aussie Bubs, Inc.58 个研究点 分布在 1 个国家目标入组 518 人开始时间: 2023年8月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 518
- 试验地点
- 58
- 主要终点
- Weight gain (g) from study entry to 16 weeks of study.
研究概览
简要总结
A 4 month growth monitoring study of healthy term infants fed iron fortified infant formula. Infants will be fed ad-libitum for 16 weeks and growth will be evaluated in terms of weight gain over the 16 weeks.
详细描述
A Growth Monitoring Study conducted according to FDA established guidelines to evaluate the test infant formulas ability to promote normal growth and development.
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)
盲法说明
Study infant formulas have been blinded
入排标准
- 年龄范围
- 1 Day 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Term Infant
排除标准
- •Any health condition that would negatively impact infant feeding and growth.
结局指标
主要结局
Weight gain (g) from study entry to 16 weeks of study.
时间窗: 16 weeks of Clinical Study
Growth Monitoring Study
次要结局
- Recumbent length gain (cm) from study entry to 16 weeks of study.(16 weeks of Clinical Study)
- Tolerance of study formulas over 16 weeks of study(16 weeks of Clinical Study)
- Head Circumference gain (cm) from study entry to 16 weeks of study(16 weeks of Clinical Study)
研究者
研究点 (58)
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