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

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

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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