Probiotic supplementation and its effect on feed tolerance and weight gain in low birth weight infants on orogastric feeds- A Randomized controlled trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the time taken(in days) to reach full enteral feeds(150ml/kg/day) in low birth weight infants on orogastric feeds between the probiotic and no probiotic group.
研究概览
简要总结
Establishment of full feeds and feeding management is an emerging challenge in the care of Low birth weight infants. Probiotics are live microbial supplements that colonize the bowel of these neonates with favourable flora, improve feed tolerance and enhances growth of these infants. However probiotics are not yet used as a standard of care and no study has been done in our area for their use. Hence this study is planned in which Low birth weight infants will be divided into 2 groups out of which feeds of infants of one group will be supplemented with probiotics and other group will be given only feeds. The two groups will be compared for the role of probiotics in Low birth weight infants in time taken to reach full feeds, episodes of feed intolerance, weight gain, duration of hospital stay, incidence of NEC stage 2 or more and morbidity and mortality during hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All neonates with a birth weight between 1000 to 1800gm admitted to the NICU in whom enteral feeds can be started.
排除标准
- •Neonates with weight<1000gm.
- •Neonates with gastrointestinal anomalies.
- •Neonates with major congenital malformations.
- •Neonates in whom the feed could not be started by day 14 of life.
结局指标
主要结局
To compare the time taken(in days) to reach full enteral feeds(150ml/kg/day) in low birth weight infants on orogastric feeds between the probiotic and no probiotic group.
时间窗: Time taken to reach full enteral feeds
To compare episodes of feed intolerance and weight gain in both the groups.
时间窗: Time taken to reach full enteral feeds
次要结局
- To compare the duration of hospital stay, incidence of NEC stage 2 or more, other morbidity and mortality during hospital stay in both the groups.