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Exclusive Enteral Nutrition in Preterm Neonates

NCT04337710 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-08-17

No results posted yet for this study

Summary

To test the hypothesis that early exclusive enteral nutrition with the minimal use of parenteral nutrition will improve preterm infants' nutritional outcomes when compared to delayed progression of enteral nutrition and prolonged use of parenteral nutrition.

Conditions

  • Premature; Infant, Light-for-dates
  • Enteral Feeding Intolerance

Interventions

PROCEDURE

Exclusive Enteral Nutrition

Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.

PROCEDURE

Progressive Enteral Nutrition

Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Vivek Shukla, MD · University of Alabama at Birmingham

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

  • Jacqueline Razzaghy, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
48 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-27
Primary Completion
2022-09-12
Completion
2026-05-31

Countries

  • United States

Study Locations

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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 NCT04337710 on ClinicalTrials.gov