NCT04389606已完成不适用
Follow-up Study of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ByHeart
- 入组人数
- 311
- 试验地点
- 54
- 主要终点
- Weight Gain Velocity
研究概览
简要总结
The purpose of this two-month follow-up study is to continue to follow growth, safety, and other health outcomes of infants fed a new infant formula for term infants or comparator formula. A reference group of human milk-fed infants will also be followed. This study is designed in accordance with Good Clinical Practice guidelines.
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)
入排标准
- 年龄范围
- 16 Weeks 至 19 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who enrolled and completed the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
排除标准
- •Subjects who did not enroll in the previous phase of the clinical trial: NCT04218929 "Evaluation of Growth, Safety, and Efficacy of an Infant Formula for Healthy Term Infants"
结局指标
主要结局
Weight Gain Velocity
时间窗: up to 24 weeks
G/D
次要结局
- Weight Measures(20 weeks, 24 weeks)
- 72-hr record of formula intake at each study visit(20 weeks, 24 weeks)
- Human milk composition (concentrations of proteins, lipids, carbohydrates, vitamins, and minerals(24 weeks)
- Weight for length Z-scores(20 weeks, 24 weeks)
- Parent report of infant stool frequency at each study visit(20 weeks, 24 weeks)
- Weight for age Z-scores(20 weeks, 24 weeks)
- Stool microbiome(24 weeks)
- Head Circumference Measures(20 weeks, 24 weeks)
- Length for age Z-scores(20 weeks, 24 weeks)
- Blood concentrations of amino acids (umol/L)(24 weeks)
- Length Measures(20 weeks, 24 weeks)
- Length Gain Velocity(20 weeks, 24 weeks)
- Head circumference for age Z-scores(20 weeks, 24 weeks)
- Blood concentrations of Interleukin-6 (pg/mL), Interleukin-10 (pg/mL), and tumor necrosis factor-alpha (pg/mL)(24 weeks)
- Medically-diagnosed adverse events collected throughout the study period(16-24 weeks)
- Parent rating of infant stool consistency at each study visit(20 weeks, 24 weeks)
- Parent report of infant disposition (fussiness, crying, gas, spit up, Infant Characteristics Questionnaire) at each study visit(20 weeks, 24 weeks)
- Stool metabolome(24 weeks)
研究者
研究点 (54)
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