跳至主要内容
临床试验/CTRI/2025/07/090829
CTRI/2025/07/090829尚未招募不适用

A Study Comparing Semi-Continuous and Bolus Feeding in Premature Babies Weighing Less Than 1250 Grams to See Which Method Improves Feeding Tolerance

Madhukar Rainbow Children Hospital1 个研究点 分布在 1 个国家目标入组 58 人开始时间: 2025年7月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
58
试验地点
1
主要终点
Time to reach full enteral feeds—was the day on which the infant tolerated the target feeding volume without interruption, measured from the start of enteral feeding.

研究概览

简要总结

With advances in neonatal care  survival of neonates has increased .one of the indications for admission in nicu is prematurity and low birth weight. Babies are given either semicontinuous gastric infusion  or intermittent gastric bolus as there is no coordination in sucking and swallowing ,a requirement for oral feeding. There are limited studies related to which method leads to early attainment of full feeds and better weight gain.so a study is planned to compare semicontinuous versus bolus feeding and its outcome in form of attainment of full feeds, weight gain and feed intolerance.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Infants with a birth weight of less than 1250 grams who are hemodynamically stable and whose parents have provided consent were included in the study.

排除标准

  • Infants with congenital malformations, chromosomal anomalies, shock requiring inotropic support, or without parental consent were excluded from the study.

结局指标

主要结局

Time to reach full enteral feeds—was the day on which the infant tolerated the target feeding volume without interruption, measured from the start of enteral feeding.

时间窗: Outcome will be assessed at 4 weeks from start date.

次要结局

  • The outcomes assessed will include the number of NPO days, events necessitating discontinuation of feeds (such as apnea, bradycardia, or vomiting), daily weight gain, & the occurrence of necrotizing enterocolitis (NEC).(Outcome will be assessed based on time to regain birth weight on daily basis till 4 to 8 weeks.)

研究者

发起方
Madhukar Rainbow Children Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Neeraj Kumar

Madhukar Rainbow Childrens Hospital

研究点 (1)

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