NCT00707837已完成3 期
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 16
- 主要终点
- The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
研究概览
简要总结
An evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Birthweight 500-1800 g
- •Less than 33 wks gestational age
- •Enteral feeding initiated by 21 days of life
- •Asymmetrical small-for-gestational age (SGA) infants and infants with patent ductus arteriosus (PDA) are eligible to participate
- •Singleton or twin births only
- •Infant is 21 days of age or less at time of randomization
排除标准
- •Serious congenital abnormalities that may affect growth and development
- •Grade III or IV intraventricular hemorrhage (IVH)
- •Maternal incapacity
- •History of major surgery
- •Extracorporeal membrane oxygenation (ECMO)
- •Confirmed NEC or positive blood cultures at the time of randomization
结局指标
主要结局
The primary objective of this study is to compare the serum concentrations of fat soluble compounds in preterm infants fed a regimen of preterm formulas and in human milk fed infants
时间窗: variable
次要结局
- Measures of eye function, ROP, measures of skin lipid soluble compound concentration(variable)
研究者
研究点 (16)
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