Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Infant body composition
研究概览
简要总结
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.
详细描述
Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).
Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.
Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.
If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Clinicians and technicians responsible for the assessment of infant body composition will be masked.
入排标准
- 年龄范围
- 1 Day 至 21 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 25 and 28 weeks of gestation
- •Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.
排除标准
- •Necrotizing enterocolitis (NEC) stage 2 or greater.
- •Gastrointestinal or neurologic malformations.
- •Terminal illness needing to limit or withhold support will be exclusion criteria.
结局指标
主要结局
Infant body composition
时间窗: Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age
Percent body fat estimated by air displacement plethysmography
次要结局
- Length(Birth to 3 months of corrected age)
- Necrotizing enterocolitis(Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first)
- Infant body composition(Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first))
- Body mass index(Birth to 3 months of corrected age)
- Growth(Birth to 3 months of corrected age)
- Head circumference(Birth to 3 months of corrected age)
- Death(Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first)
研究者
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham