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临床试验/CTRI/2021/12/038613
CTRI/2021/12/038613尚未招募不适用

Early Versus Late Feeding in Preterm neonates with Absent or Reversed End Diastolic Flow on Antenatal Umbilical Doppler studyâ€: A Randomized Controlled Trial

Bai Jerbai Wadia Hospital for Children1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Time taken to achieve full enteral feeds

研究概览

简要总结

This study is being conducted in preterm babies born with antenatal abnormal dopplers . After randomization these babies will be divided into two groups , early and late feeding groups  and will be fed according to the protocol till they reach a full feeds of 150 ml per kg per day. during their hospital stay , babies will be monitored for signs of feed intolerance and action will be taken accordingly.Time taken to reach full feed will be taken as primary outcome . And ,incidence of NEC, day of regaining birthweight, duration of Parenteral nutrition, duration of hospitalization and incidence of late onset sepsis will be the secondary outcome.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
1.00 Day(s) 至 2.00 Day(s)(—)
性别
All

入选标准

  • Preterm babies with abnormal dopplers will be randomized within 6 hours of life.

排除标准

  • 1.Neonates with major congenital malformations including gastrointestinal obstruction 2.Babies with known chromosomal abnormality or with dysmorphic features 3.Neonates with severe birth asphyxia (APGAR <4 at 5 min of life with cord/within 1 hour of life pH <7) 4.Twin to twin transfusion 5.Neonates requiring intrauterine transfusion or exchange transfusion 6.Significant multi-organ failure prior to trial entry 7.Inotropic support prior to trial entry 8.Already received any enteral feeding.

结局指标

主要结局

Time taken to achieve full enteral feeds

时间窗: till the hospital stay

次要结局

  • 1.Incidence of NEC(2.Day of regaining birthweight)

研究者

申办方类型
Research institution

研究点 (1)

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