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临床试验/CTRI/2026/02/102715
CTRI/2026/02/102715尚未招募不适用

A Three-Arm, Parallel-Group Randomized Controlled Trial Comparing Continuous, Standard Bolus, and Accelerated Continuous Enteral Feeding in Neonates with Birth Weight less than 1.8 kg

KRITI SHOKEEN1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2026年6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
180
试验地点
1
主要终点
To compare the time (in days) to achieve full enteral feeds (150 ml/kg/day) across the three feeding regimens

研究概览

简要总结

Low birth weight neonates often experience feeding intolerance and delayed achievement of full enteral nutrition due to gastrointestinal immaturity. Various enteral feeding strategies such as continuous and bolus feeding are practiced, but there is limited evidence regarding the optimal feeding method for neonates weighing less than 1.8 kg.

This study is a single-center, randomized controlled trial conducted in a tertiary care neonatal intensive care unit to compare continuous enteral feeding, standard bolus feeding, and accelerated continuous feeding in neonates weighing less than 1.8 kg. Eligible, hemodynamically stable neonates will be randomized into one of the three feeding groups. Enteral feeds will be initiated and advanced as per predefined protocols using expressed breast milk.

The primary outcome is the time taken to achieve full enteral feeds (150 ml/kg/day). Secondary outcomes include growth parameters, incidence of necrotizing enterocolitis, apnea, sepsis, and length of hospital stay. The findings of this study aim to identify the safest and most effective enteral feeding strategy for low birth weight neonates and guide evidence-based clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant 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

  • Neonates with a birth weight less than 1.8kg eligible for nasogastric (NG)feeding admitted in NICU hemodynamically stable and eligible to start enteral feeding as per unit protocol.

排除标准

  • Major congenital anomalies, particularly gastrointestinal anomalies Severe perinatal asphyxia Conditions contraindicating enteral feeding (e.g., necrotizing enterocolitis at baseline).

结局指标

主要结局

To compare the time (in days) to achieve full enteral feeds (150 ml/kg/day) across the three feeding regimens

时间窗: Assessed daily from initiation of enteral feeding until achievement of full enteral feeds (150 ml/kg/day) or till discharge, whichever is earlier

次要结局

  • Secondary:(1. To compare the rate of weight gain (g/kg/day) among neonates receiving the three feeding regimens.)

研究者

发起方
KRITI SHOKEEN
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

KRITI SHOKEEN

MGM MEDICAL COLLEGE, AURANGABAD, MAHARASHTRA

研究点 (1)

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