Early Liquid Protein Supplementation of Human Milk in Extremely Low Birth Weight Infants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Growth velocity
研究概览
简要总结
We hypothesize that premature infants who receive their mothers' expressed breast milk supplemented with liquid protein early in their hospitalization will have a growth velocity in the first 28 days of life that is 20% greater than the growth velocity of premature infants that do not receive protein fortification.
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
- None
入排标准
- 年龄范围
- 26 Weeks 至 33 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •inborn at Mount Sinai Medical Center
- •gestational age between 26 0/7 weeks and 32 6/7 weeks gestation
- •plan by family for their infant to receive human milk feeds
排除标准
- •outborn infants
- •gestational age < 26 0/7 weeks or > 33 0/7 weeks
- •major congenital anomalies including cardiac disease, inborn errors of metabolism etc.
- •sepsis and/or other serious clinical complication precluding initiation of enteral feeds
- •plan by family for their infant to receive primarily preterm infant formula.
研究组 & 干预措施
liquid protein supplement
Study subjects will receive standard of care nutrition with the addition of a liquid protein supplement when the baby is able to tolerate an enteral feeding volume of 40mL/kg/day.
干预措施: liquid protein supplement (Dietary Supplement)
Control group
Study subjects will receive standard of care nutrition
结局指标
主要结局
Growth velocity
时间窗: up to 28 days
Growth velocity over the first 28 days of life - Daily weight measurements for the first 28 days of life
次要结局
- weight(average 11 weeks)
- head circumference(average 11 weeks)
- Length(average 11 weeks)
研究者
Andrea Weintraub
Associate Professor
Icahn School of Medicine at Mount Sinai