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临床试验/CTRI/2024/01/061086
CTRI/2024/01/061086尚未招募不适用

Stopping Versus Continuing Enteral Feeds Around Red Cell Transfusion and its Effect on Transfusion Associated Necrotising Enterocolitis in Preterm Neonates : A Pilot Randomised Study

Bai Jerbai Wadia Hospital for Children1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月8日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kiran More

Bai Jerbai Wadia Hospital for Children,Mumbai

研究点 (1)

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