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Clinical Trials/CTRI/2025/07/090829
CTRI/2025/07/090829Not yet recruitingNot Applicable

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 site in 1 country58 target enrollmentStarted: July 25, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
58
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
1.00 Day(s) to 28.00 Day(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: Outcome will be assessed at 4 weeks from start date.

Secondary Outcomes

  • 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.)

Investigators

Sponsor
Madhukar Rainbow Children Hospital
Sponsor Class
Private hospital/clinic
Responsible Party
Principal Investigator
Principal Investigator

Dr Neeraj Kumar

Madhukar Rainbow Childrens Hospital

Study Sites (1)

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