Preterm Neonatal Feeding Protocol Comparing Feed Administration Time
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
研究概览
简要总结
Doctors have tried many different methods of feeding to try to decrease feeding intolerance in preterm babies so that they spend less time receiving liquid nutrition and have fewer problems with feeding intolerance.
The purpose of this study is to test two different methods of feeding preterm babies in the hopes of identifying a method that will decrease some of the feeding intolerance that can occur when feeding premature babies.
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
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any infant born at OHSU or transferred in from another facility whose birthweight is greater than 500 grams and less than 1500 grams, and whose gestational age is less than 32 weeks.
排除标准
- •Any infant who has major anomalies including but not limited to *gastroschisis
- •omphalocele
- •bowel obstruction or atresia
- •tracheo-esophageal fistula
- •Hirschsprung's Disease
- •congenital diaphragmatic hernia
- •congenital heart disease and other major syndromes
- •infants who have started enteral feeds prior to entering the study
- •Any infant whose birth weight is greater than or equal to 1500 grams or less than 500 grams
- •Any infant whose gestational age is greater than 32 weeks.
研究组 & 干预措施
Group 1 Bolus Feeds
This group will receive feeds administered by bolus method over no more than 30 minutes per feed.
干预措施: Length of time for feed administration (Other)
Group 2- Slow Infusion Feeds
This group will receive feeds administered by slow infusion over pump for 2 hours.
干预措施: Length of time for feed administration (Other)
结局指标
主要结局
To compare feeding intolerance between these two groups as defined by the following criteria: the number of times that the signs and symptoms in an infant caused the perception of feeding intolerance with feeds paused for longer than one feeding.
时间窗: Daily
次要结局
- To compare the number of days it takes the infant to reach full feeds.(After reaching full feeds.)
- To compare the number of days the infant requires intravenous nutrition.(After reaching full feeds.)
- To compare the number of days of overall hospitalization duration.(After patient discharge.)
研究者
Sue Ann Smith
MD, Neonatologist
Oregon Health and Science University