NCT02953223已完成不适用
A Study to Monitor the Use of an Amino Acid-Based Infant Formula
Société des Produits Nestlé (SPN)29 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2017年1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
- 144
- 试验地点
- 29
- 主要终点
- Adverse events
研究概览
简要总结
To assess the frequency and nature of adverse events in infants fed a free amino acid based infant formula.
详细描述
Prospective, post-market surveillance program to be conducted in the United States (US). Infant will be invited to enroll by their healthcare provider who recommends the use of a free amino acid based infant formula
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants who use a free amino acid based Infant formula during their first year of life including:
- •Those that are currently consuming the formula at the time of enrollment
- •Those for whom consumption of the formula is planned
- •At least one parent/guardian is willing to provide written informed consent form (ICF) for participation in the surveillance program
排除标准
- •Infants <37 weeks of corrected gestation age (CGA) at time of enrollment
结局指标
主要结局
Adverse events
时间窗: 4 months
To assess the frequency and nature of adverse events in infants consuming a free amino acid based infant formula
次要结局
- Clinical characteristics(4 months)
研究者
研究点 (29)
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