NCT02307760已完成不适用
Evaluation of Two Human Milk Fortifiers in Preterm Infants
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 36
- 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 one of two commercially available human milk fortifiers.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight of 700 g-1500 g.
- •≤ 32 weeks and 0 days GA at birth.
- •Appropriate for GA (AGA).
- •Enteral feeding of human milk initiated by 21 days of life (birth date is day of life 0).
- •Mother agrees to provide human milk as the exclusive feeding during the study period; use of donor milk is permitted if the plan is that it will be fortified.
- •Parent(s) agrees to allow infant to receive both human milk and HMF.
- •Singleton or twin births only.
排除标准
- •Enteral feeding of preterm infant formula or HMF for > 7 days.
- •Expected to be transferred to another facility and will not be able to be followed for at least 15 days.
- •Serious congenital abnormalities or underlying disease that may affect growth and development.
- •5 minute APGAR ≤
- •Steroids used at the time of randomization.
- •Grade III or IV periventricular/intraventricular hemorrhage (PVH/IVH).
- •Mechanical ventilator dependence.
- •Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
- •Infant has a history of major surgery (intra-thoracic or intra-abdominal procedures or other surgery requiring general anesthesia).
- •Asphyxia defined as progressive hypoxemia and hypercapnia with significant metabolic acidemia characterized by APGAR score <3 at 10 minutes, seizures within the first 12 hours of life, or a cord blood gas < 7.0 and seizures and/or severe tonic abnormalities in the first 12 hours of life (24).
- •Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
- •Infant has any other condition that, in the opinion of the investigator, precludes participation in the study.
- •Participation in another study that has not been approved as a concomitant study by AN.
结局指标
主要结局
Weight Gain
时间窗: Study Day 1 to Study Day 29 (or discharge, whichever happens first)
scale measurement g/kg/d
次要结局
- Gastrointestinal Tolerance(Study Day 1 to Study Day 29 (or discharge, whichever happens first))
- Length(Study Day 1 to Study Day 29 (or discharge, whichever happens first))
- Head Circumference(Study Day 1 to Study Day 29 (or discharge, whichever happens first))
研究者
研究点 (36)
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