NCT00707837已完成3 期
Effect of Supplemental Infant Formula on Blood Levels in Preterm Infants
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 8
- 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
研究组 & 干预措施
Infant Formula
Experimental
Preterm infant formulas containing lipid soluble compounds
干预措施: Preterm infant formula with added soluble lipids (Other)
Preterm formulas
Active Comparator
Standard preterm infant formula and discharge formulas
干预措施: Preterm infant formulas and discharge formulas (Other)
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 (8)
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