Stopping Versus Continuing Enteral Feeds Around Red Cell Transfusion and its Effect on Transfusion Associated Necrotising Enterocolitis in Preterm Neonates : A Pilot Randomised Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Incidence of Necrotising Enterocolitis Post Packed Red Blood Cell Transfusion
研究概览
简要总结
All preterm neonates less than 34 weeks of gestation meeting the inclusion and exclusion criteria will be included in the study. This is a pilot randomised open label unblinded single centre study. The sample size is 50. The neonates will be divided into 2 study groups by a computer generated randomisation sequence. In the first group, the neonates will be kept nil per oral for 4 hours before, during and after Packed Red Blood Cell transfusion and in the second group enteral feeds will be continued before, after and throughout the transfusion. The neonates will be monitored for features of Necrotising enterocolitis occuring within 48 hours of Packed red cell transfusion using Modified Bell’s Staging.This study will help us to ascertain whether stopping feeds during and around packed red blood cell transfusion has any role in reducing the incidence of Transfsuion Associated Necrotising enterocolitis. The primary outcome is incidence of Necrotising enterocolitis post packed red cell transfsuion in preterm neonates. The secondary outcomes are neonatal moratlity, duration of NICU stay, duartion of ventilation and growth parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 4.00 Month(s)(—)
- 性别
- All
入选标准
- •All Neonates less than or equal to 34 weeks of Gestational age admitted to the NICU.
排除标准
- •Parents opting out of the trial -Contraindication to enteral feeds -Has previously received enteral feeds during blood transfusion.
结局指标
主要结局
Incidence of Necrotising Enterocolitis Post Packed Red Blood Cell Transfusion
时间窗: 48 hours
次要结局
- Duration of NICU stay(Neonatal Mortality)
研究者
Dr Kiran More
Bai Jerbai Wadia Hospital for Children,Mumbai
