NCT01373073已完成3 期
Evaluation of a Novel Human Milk Fortifier in Preterm Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 30
- 主要终点
- Weight gain
研究概览
简要总结
The purpose of this study is to assess growth of preterm infants fed human milk supplemented with an experimental human milk fortifier.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •700-1500g birth weight
- •33 weeks or less gestational age
- •Appropriate for gestational age
- •Initiate enteral feeds of human milk by 21 days of life
- •Mother provided exclusive human milk feeds
- •Parents allow both human milk and study human milk fortifier
- •Singleton or twin birth
排除标准
- •Feeding preterm infant formula or non-study human milk fortifier
- •Expected at facility less than 15 days
- •Congenital anomalies/disease affecting growth and development
- •5 minute APGAR of 4 or less
- •Steroid use
- •Grade III or IV PVH/IVH
- •Mechanical ventilator dependency
- •Maternal incapacity
- •History of major surgery
- •Confirmed NEC or sepsis
- •Use of probiotics
结局指标
主要结局
Weight gain
时间窗: 29 days
次要结局
- Anthropometric variables(29 days)
- GI tolerance(29 days)
研究者
研究点 (30)
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