Exclusive Enteral Nutrition in Preterm Neonates- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
研究概览
简要总结
To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.
详细描述
Qualifying participants will be randomly assigned to one of two study groups: 1) Exclusive Enteral Feeds or 2) Progressive Enteral Feeds with supplemental parenteral nutrition. Regardless of study group assignment, donor human milk will be offered if the mother's expressed breast milk is not enough to complete the intervention as assigned.
Intervention group: Feeds will be initiated with a target volume of 60-80 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150ml/kg/day is achieved.
Control group: Enteral feeds will be initiated with a target volume of 20-30 ml/kg/day and then advanced by 20-30 ml/kg/day until the total volume of 150 ml/kg/day is achieved.
If parent agrees, stool "dirty" diapers will be collected 2 times during this study.
One time around the time of birth and one time at 28 days or discharge (whichever occurs first).
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 Hour 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 28 and 32 weeks of gestation
排除标准
- •Intrauterine growth restriction (birth weight < 10th percentile)
- •Major congenital or chromosomal anomalies
- •Terminal illness in which decisions to withhold or limit support have been made
结局指标
主要结局
Number of days of full enteral feeding (150ml/kg/day) in the first 28 days after birth
时间窗: Birth to 28 days
Days of full feeds in the first 28 days after birth
次要结局
- Number of days receiving parenteral nutrition and IV fluids(Birth to 28 days)
- Number of days receiving central line access(Birth to 28 days)
- Duration of hospital stay in days(Birth to 60 days)
- Time to establish full enteral feeding(Birth to 28 days)
- Number of participants with diagnosis of necrotizing enterocolitis(Birth to 60 days or discharge, whichever occurs first)
- Length(Birth to 60 days)
- Number of episodes of culture proven sepsis(Birth to 60 days or discharge, whichever occurs first)
- Weight(Birth to 60 days)
- Number of episodes of feeding intolerance(Birth to 28 days)
- Number of participants with diagnosis of intestinal perforation(Birth to 14 days)
- Death(Birth to 60 days)
- Head circumference(Birth to 60 days)
研究者
Ariel A. Salas
Assistant Professor
University of Alabama at Birmingham