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
- 1
- 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.
研究组 & 干预措施
High protein supplementation
Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.
干预措施: High protein supplementation (Dietary Supplement)
Standard protein supplementation
Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.
干预措施: Standard protein supplementation (Dietary Supplement)
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