Multi-Center Clinical Database of Infants for the Investigation of Early Nutrition Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- ByHeart
- 入组人数
- 2,000
- 试验地点
- 8
- 主要终点
- Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
研究概览
简要总结
An observational study to generate a long-term outcome database from medical records for infants who completed protocol SS-101-18 or infants who are breastfed, fed commercial formula, or fed a marketed ByHeart formula.
详细描述
The first Cohort (Cohort 1) goals of the registry include: to compile a clinical database of children who were fed in SS-101-18 by breastfeeding, commercial formula, or ByHeart formula; to investigate any difference in demographics, growth, development, medical diagnoses, and outcomes between the feeding groups, and in particular to compare ByHeart formula-fed infants against commercial formula-fed infants, and referenced against breastfed infants.
The second Cohort (Cohort 2) goals of the registry include: to compile a clinical database of children who were fed by breastfeeding or commercial formula (including ByHeart formula); to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake; and to inform or facilitate development of future ByHeart products.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Days 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cohort 2: Growth, Development, Diagnoses, and Long-term Outcomes
时间窗: 5 years
A clinical database of children of all feeding options; to describe any difference in growth, development, medical diagnoses, and outcomes based on early nutritional intake
Cohort 1: Growth, Development, Diagnoses, and Long-term Outcomes
时间窗: 5 years
The registry will be utilized to investigate growth, development, diagnoses, and long-term outcomes of infants who received ByHeart study formula, commercially available formula, or breastmilk in the SS-101-18 protocol.
次要结局
未报告次要终点