NCT06076460

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

August 31, 2023

Last Update Submit

August 12, 2024

Conditions

Very Preterm Maturity of InfantEnteral Feeding Intolerance

Outcome Measures

Primary Outcomes (1)

  • Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth

    Days to attain full feeds during the first 28 days after birth

    Birth to 28 days

Secondary Outcomes (8)

  • Number of episodes of feeding intolerance

    From Randomization till 28 days after birth

  • Incidence of Necrotising Enterocolitis

    From Randomization till 28 days after birth

  • Incidence of Sepsis

    From randomization till 28 days after birth

  • Total duration of intravenous fluid usage

    From randomization till 28 days after birth

  • Time of regaining birth weight

    From randomization till 28 days after birth

  • +3 more secondary outcomes

Study Arms (2)

Early Total Enteral Feeding

EXPERIMENTAL

Mom's milk or donor milk at 80 ml/kg/day after randomization within the first 2 hours

Other: Early Total Enteral Feeding

Conventional Enteral Feeding

ACTIVE COMPARATOR

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.

Other: Conventional Enteral Feeding

Interventions

Early Total Enteral FeedingOTHER

This group will receive enteral feeding volumes at a rate 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.

Early Total Enteral Feeding
Conventional Enteral FeedingOTHER

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.

Conventional Enteral Feeding

Eligibility Criteria

AgeUp to 1 Hour
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Preterm neonate with gestational age of 27-32 weeks

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

Location

Related Publications (2)

  • Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2.

    PMID: 33368149BACKGROUND

  • Nangia S, Bishnoi A, Goel A, Mandal P, Tiwari S, Saili A. Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study. J Trop Pediatr. 2018 Feb 1;64(1):24-30. doi: 10.1093/tropej/fmx023.

    PMID: 28431170BACKGROUND

Study Officials

  • Sushma Nangia, DM (NEO)

    Lady Hardinge Medical College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sushma Nangia, Director Professor & Head, Neonatology

Study Record Dates

First Submitted

August 31, 2023

First Posted

October 10, 2023

Study Start

March 11, 2022

Primary Completion

January 10, 2024

Study Completion

January 10, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)