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Effect of Increased Enteral Protein on Body Composition of Preterm Infants

NCT03586102 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-05-28

No results posted yet for this study

Summary

The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Conditions

  • Premature Infant

Interventions

DIETARY_SUPPLEMENT

High protein supplementation

To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive \> 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.

DIETARY_SUPPLEMENT

Standard protein supplementation

Infants assigned to the standard protein supplementation group will receive fortified human milk (\< 4.5 g/kg/day of enteral protein)

Sponsors & Collaborators

  • Children's Health System, Alabama

    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
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2020-04-30
Completion
2025-04-24

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 NCT03586102 on ClinicalTrials.gov