Re-feeding Residuals Versus Feeding Fresh Formula/Milk for Feeding Intolerance in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Time to establish full enteral feeding
研究概览
简要总结
The purpose of this study is to determine whether re-feeding of gastric residuals reduces the time needed to establish full enteral feedings in premature infants. Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Primary outcome measure is time to establish full enteral feedings (120cc/kg/day).
详细描述
Infants with gestational ages 23-28 weeks at birth will be randomized within one week to receive either gastric residuals or fresh formula or breastmilk whenever significant residuals during feeding advancement require clinical assessment for continuing feedings. Feeding advancement determined by clinical physicians.
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
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 23.0 and 28.6 weeks;
- •Receiving intravenous fluids but not enteral nutrition more than trophic feeds;
- •Written informed consent from the parents
排除标准
- •Major congenital/chromosomal anomalies;
- •Moribund infant with low likelihood of survival, in the opinion of the clinical team
研究组 & 干预措施
Re-feeding gastric residuals
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
干预措施: Re-feeding residuals (Procedure)
Fresh feeding breastmilk/formula only
In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breast milk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
干预措施: Fresh Feeding Breastmilk or Formula only (Procedure)
结局指标
主要结局
Time to establish full enteral feeding
时间窗: Birth to 28 days
Time required to reach enteral feeding at 120cc/kg/day
次要结局
- Feeding intolerance(Birth to 28 days)
- Episodes of feeding intolerance resulting in a interruption or cessation of progression of enteral feeds for a period of < 12 hours.(Birth to 28 days)
- Number of days receiving parenteral nutrition(Birth to 28 days)
- Duration of hospital stay(Birth to 120 days or discharge, whichever occurs first.)
- Diagnosis of necrotizing enterocolitis(Birth to 120 days or discharge, whichever occurs first.)
- Diagnosis of intestinal perforation(Birth to 120 days or discharge, whichever occurs first)
- Death(Birth to 120 days)
研究者
Ariel Salas, MD
Fellow Instructor, Department of Pediatrics, Division of Neonatology
University of Alabama at Birmingham