Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of days alive and receiving full enteral feeding
研究概览
简要总结
To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.
详细描述
Qualifying participants will be randomly assigned to one of two study groups: 1) Early progressive feeding without MEF or 2) Progressive feedings preceded by 4 days of MEF. Regardless of study group assignment, donor human milk will be offered if not enough of the mother's expressed breastmilk during the intervention phase of the trial.
Intervention group: Progressive feeding of 20-24 ml/kg/d on day 1 of feeding, followed by daily increments of 24-25 ml/kg/d as tolerated until full enteral feeding achieved.
Control group: MEF with feeding volumes of 20-24 ml/kg/d for 4 days followed by progressive feeding (daily increments of 24-25 ml/kg/d) as tolerated until full enteral feeding achieved.
Both groups will receive fast progressive feeding (>/= 24 ml/kg/day)
If parent agrees, stool "dirty" diapers will be collected 5 times (at birth, 1, 2, 3 and 4 weeks of life).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •admission to the NICU within 48 hours with gestational age between 22.0 and 28.6 weeks
排除标准
- •small for gestational age (<10th percentile birthweight), major congenital or chromosomal anomalies, and infants with terminal illness in which decision to withhold or limit support have been made
结局指标
主要结局
Number of days alive and receiving full enteral feeding
时间窗: birth to 28 days
number of days alive on full enteral feeding in the first 28 days after birth
次要结局
- Changes in intestinal microbiome(birth to 28 days)
- Number of participants with diagnosis of necrotizing enterocolitis(birth to 120 days or discharge, whichever occurs first)
- Number of participants with diagnosis of intestinal perforation(birth to 14 days)
- Death(birth to 120 days)
- Number of days alive and receiving full enteral feeding according to time of exposure to human milk and formula feeding the first 28 days(birth to 28 days)
- Time to establish full enteral feeding(birth to 28 days)
- Number of episodes of feeding intolerance(birth to 28 days)
- Number of episodes of feeding intolerance resulting in an interruption or cessation of progressive enteral feeding for a period < 12 hours(birth to 28 days)
- Number of days receiving parenteral nutrition(birth to 28 days)
- Number of days requiring central line access(birth to 28 days)
- Number of episodes of culture proven sepsis(birth to 120 days or discharge, whichever occurs first)
- Growth/length at time of discharge(birth to 120 days or discharge, whichever occurs first)
- Duration of hospital stay in days(birth to 120 days or discharge, whichever occurs first)
研究者
Ariel A. Salas
Principal Investigator
University of Alabama at Birmingham