NCT06420531

Brief Summary

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
486

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Sep 2025Aug 2030

First Submitted

Initial submission to the registry

May 14, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2030

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

May 14, 2024

Last Update Submit

September 16, 2025

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

  • Fat-free Mass (FFM)-For-age-Z-score

    Estimated by bioelectric impedance analysis. FFM measurements will be converted into Z-scores using updated, sex specific reference curves of body composition in preterm infants

    36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

Secondary Outcomes (15)

  • Body fat percentage

    Birth to 36 weeks postmenstrual age

  • Anthropometric Measurements

    Birth to 36 weeks postmenstrual age

  • Bronchopulmonary Dysplasia

    36 weeks post menstrual age or hospital discharge, up to 120 days following birth, whichever is longer

  • Number of Days Alive and Receiving Full Enteral Feeding

    Birth to 28 days

  • Duration of Hospital Stay in Days

    Birth to 120 days or discharge, whichever occurs first

  • +10 more secondary outcomes

Other Outcomes (3)

  • Changes in Intestinal Microbiome

    Birth to 36 weeks postmenstrual age

  • Changes in Metabolic Pathways

    36 weeks postmenstrual age or discharge (whichever occurs first)

  • Cognitive scores

    2 - 3 years of age

Study Arms (2)

Intervention: 180-200 mL/kg/day of human milk

EXPERIMENTAL

Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.

Dietary Supplement: Human milk

Control:140-160 mL/kg/day of human milk

PLACEBO COMPARATOR

Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.

Dietary Supplement: Human milk

Interventions

Human milkDIETARY_SUPPLEMENT

maternal breastmilk or donor breastmilk

Control:140-160 mL/kg/day of human milkIntervention: 180-200 mL/kg/day of human milk

Eligibility Criteria

Age6 Hours - 4 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age between 27 0/7 and 31 6/7 weeks
  • Birthweight of 1500 grams or less
  • Human milk feeding during the first 14 days after birth
  • Full enteral feeding (120mL/kg/day or more) within the first 14 days after birth

You may not qualify if:

  • Necrotizing enterocolitis stage 2 or greater
  • Spontaneous intestinal perforation
  • Major congenital/chromosomal anomalies
  • Terminal illness requiring limited or withheld support
  • Intention to restrict fluid intake after the first 14 postnatal days due to the presence of a symptomatic patent ductus arteriosus (PDA)
  • Any formula feeding within the first 14 days after birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

NOT YET RECRUITING

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

NOT YET RECRUITING

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Milk, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Ariel A. Salas, MD, MSPH

    UAB Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel A. Salas, MD, MSPH

CONTACT

205-934-4680asalas@uab.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 20, 2024

Study Start

September 16, 2025

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

August 30, 2030

Last Updated

September 17, 2025

Record last verified: 2025-09

Locations

US(4)