NCT01987154已完成不适用
Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Enteral intake (ml/kg/day)
研究概览
简要总结
To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infant 28 to 33 weeks gestational age, inclusive, at birth
- •Infant has never received enteral feedings or current enteral intake is less than 30 mL/kg/day
- •Birth weight is greater than or equal to 700g to 1750g
- •Appropriate birth weight for gestational age
- •Singleton or twin birth
- •Signed Informed consent
排除标准
- •Infant's mother plans to exclusively breast feed
- •5 minute APGAR score is less than or equal to 4
- •Major surgery that required general anesthesia prior to randomization
- •Ventilator-dependent or requiring greater than 40% FiO2 on day of randomization
- •Grade III or IV intraventricular hemorrhage diagnosed prior to randomization
- •Infant is currently participating in another clinical study
研究组 & 干预措施
Marketed cow milk-based premature infant formula
Active Comparator
干预措施: Marketed cow milk-based premature infant formula (Other)
Marketed extensively hydrolyzed casein infant formula
Experimental
干预措施: Marketed extensively hydrolyzed casein infant formula (Other)
结局指标
主要结局
Enteral intake (ml/kg/day)
时间窗: Daily for 14 days
次要结局
- Feeding Tolerance(Daily for 14 days)
- Body Weight (g)(Daily for 14 days)
- Gut Inflammation(Once at Study Day 14)
- Respiratory status(Daily for 14 days)
- Date of hospital discharge(Once at hospital discharge)
- Growth(Study Days 1, 7, and 14)
- Confirmed or suspected sepsis or necrotizing enterocolitis(Daily for 14 days)
研究者
研究点 (1)
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