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Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation (ETEFVsCEF)

L

Lady Hardinge Medical College

Status

Completed

Conditions

Very Preterm Maturity of Infant
Enteral Feeding Intolerance

Treatments

Other: Early Total Enteral Feeding
Other: Conventional Enteral Feeding

Study type

Interventional

Funder types

Other

Identifiers

NCT06076460
LHMC/IEC/2021/03/68

Details and patient eligibility

About

The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).

Full description

Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned

Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.

Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Enrollment

183 patients

Sex

All

Ages

Under 1 hour old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Preterm neonate with gestational age of 27-32 weeks

Exclusion criteria

  1. Antenatally diagnosed GI malformation
  2. Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
  3. Presence of major congenital anomalies at birth
  4. Need of vasopressor support at the time of randomization
  5. Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

183 participants in 2 patient groups

Early Total Enteral Feeding
Experimental group
Description:
Mom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours
Treatment:
Other: Early Total Enteral Feeding
Conventional Enteral Feeding
Active Comparator group
Description:
Mom's milk or donor milk at 20 ml/kg/day and rest of the requirement as Total parenteral nutrition after randomization within the first 2 hours.
Treatment:
Other: Conventional Enteral Feeding

Trial contacts and locations

1

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Central trial contact

Tapas Bandyopadhyay, MD, DM (Neo); Sushma Nangia, DM (Neo)

Data sourced from clinicaltrials.gov

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