Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Fat-free mass(FFM)-for-age Z-score
研究概览
简要总结
In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.
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
- None
入排标准
- 年龄范围
- 1 Day 至 4 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 29 to 33 weeks of gestation
- •Birth weight < 1800 g
- •Postnatal age < 96 hours
排除标准
- •Small for gestational age (<5th percentile)
- •Major congenital/chromosomal anomalies
- •Terminal illness needing withhold or limit support
研究组 & 干预措施
Early human milk fortification (HMF) group
A human milk fortifier will be added to the feeds between days 4 to 7, after a total feeding volume greater than 120 ml/kg/day is achieved.
干预措施: Early HMF (Dietary Supplement)
Delayed human milk fortification (HMF) group
A human milk fortifier will be added to the feeds between days 10 to 14, after a total feeding volume greater than 120 ml/kg/day is achieved.
干预措施: Delayed HMF (Dietary Supplement)
结局指标
主要结局
Fat-free mass(FFM)-for-age Z-score
时间窗: Postnatal day 14 to 21
Estimated by air displacement plethysmography
次要结局
- Growth - Head circumference(Birth to 36 weeks postmenstrual age or hospital discharge)
- Growth rate(Birth to 36 weeks postmenstrual age or hospital discharge)
- Number of participants with diagnosis of intestinal perforation(Birth to 10 days)
- Death(Birth to 60 days)
- Growth - Length(Birth to 36 weeks postmenstrual age or hospital discharge)
- Fecal microbiome composition(Birth to 36 weeks postmenstrual age)
- Duration of hospital stay in days(Birth to 60 days or discharge, whichever occurs first)
- Growth - Weight(Birth to 36 weeks postmenstrual age or hospital discharge)
- Number of participants with postnatal growth faltering(Birth to 36 weeks postmenstrual age or hospital discharge)
- Number of participants with diagnosis of necrotizing enterocolitis(Birth to 60 days or discharge)
研究者
Ariel A. Salas
Associate Professor of Pediatrics
University of Alabama at Birmingham