NCT03586102

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 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

First Submitted

Initial submission to the registry

June 1, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

June 1, 2018

Last Update Submit

May 26, 2025

Conditions

Premature Infant

Keywords

Protein supplementationHuman milk fortification

Outcome Measures

Primary Outcomes (1)

  • Infant body composition

    Percent body fat estimated by air displacement plethysmography

    Assessed at 36 weeks of postmenstrual age or at 3 months of corrected age

Secondary Outcomes (7)

  • Infant body composition

    Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first)

  • Growth

    Birth to 3 months of corrected age

  • Length

    Birth to 3 months of corrected age

  • Head circumference

    Birth to 3 months of corrected age

  • Body mass index

    Birth to 3 months of corrected age

  • +2 more secondary outcomes

Other Outcomes (2)

  • Changes in intestinal microbiome

    Birth to 3 months of corrected age

  • Changes in metabolic pathways

    Birth to 3 months of corrected age

Study Arms (2)

High protein supplementation

EXPERIMENTAL

Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Dietary Supplement: High protein supplementation

Standard protein supplementation

ACTIVE COMPARATOR

Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.

Dietary Supplement: Standard protein supplementation

Interventions

High protein supplementationDIETARY_SUPPLEMENT

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.

High protein supplementation
Standard protein supplementationDIETARY_SUPPLEMENT

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

Standard protein supplementation

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 25 and 28 weeks of gestation
  • Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.

You may not qualify if:

  • Necrotizing enterocolitis (NEC) stage 2 or greater.
  • Gastrointestinal or neurologic malformations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • Salas AA, Jerome M, Finck A, Razzaghy J, Chandler-Laney P, Carlo WA. Body composition of extremely preterm infants fed protein-enriched, fortified milk: a randomized trial. Pediatr Res. 2022 Apr;91(5):1231-1237. doi: 10.1038/s41390-021-01628-x. Epub 2021 Jun 28.

    PMID: 34183770BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Ariel A. Salas, MD, MSPH

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Clinicians and technicians responsible for the assessment of infant body composition will be masked.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 13, 2018

Study Start

August 23, 2018

Primary Completion

April 30, 2020

Study Completion

April 24, 2025

Last Updated

May 28, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)