Clinical trial

A Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm

NCT06420531

Name

IRB-300013026

Description

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 arms

Trial start

2025-04-01

Estimated PCD

2028-06-01

Trial end

2030-05-01

Status

Not yet recruiting

Treatment

Human milk

maternal breastmilk or donor breastmilk

Arms:

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

Size

486

Primary endpoint

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

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

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 486, 'type': 'ESTIMATED'}}

Updated at

2024-05-22

1 organization

1 product

1 indication

Organization

University of Alabama at Birmingham

Product

Human milk

Indication

Premature Birth