MedTrace Logo

Early Progressive Feeding in Human-Milk Fed Extremely Preterm Infants: A Randomized Trial

NCT02915549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-16

No results posted yet for this study

Summary

To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

Conditions

  • Premature; Infant, Light-for-dates

Interventions

OTHER

Progressive Feeding without MEF

This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

OTHER

Progressive Feeding with MEF

This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ariel A. Salas, MD, MSPH · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-10-31
Completion
2022-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02915549 on ClinicalTrials.gov