Effects of Infant Formula on the Growth and Tolerance in Preterm/Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 10
- 主要终点
- Weight
研究概览
简要总结
This is a two stage open-label, single-arm, multicenter and observational study.
详细描述
Stage 1: In hospital, preterm/low birth weight infants less than or equal to 34 weeks gestational age at birth, birth weight of ≥ 1000g to <1800g and conditions meeting the enrollment criteria will be fed formula with or without parenteral nutrition until discharge. Stage 2: Post-discharge, all infants with birth weight < or =1500g will be followed on formula per standard of care and accepted standard of care including feeding until the infant's weight >or= 25th percentile of growth expectation based on corrected age (P25) or until infant reaches 9 months corrected age.
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
- — 至 21 Days(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
Weight
时间窗: Change from first feeding to discharge (up to ~8 weeks)
次要结局
- Length(Change from first feeding to discharge (up to ~8 weeks))
- Head Circumference(Change from first feeding to discharge (up to ~8 weeks))
- Hospitalization Length of Stay(Time from Birth to discharge (up to ~8 weeks))
- Gastrointestinal Tolerance(From first feeding to discharge (up to ~8 weeks))
- Catch Up Growth(From discharge to 9 months corrected age)
