Optimizing Human Milk Intake for Growth and Gut Health in Very Preterm Infants

Prematurity Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Participants will be randomized once they reach 120 mL/kg/day. Clinicians will be able to increase feeds each day as they see fit, until the patient reaches the target goal of 140-160 mL/kg/day or 180-200 mL/kg/day. They will then maintain this volume until 34 weeks postmenstrual age. Researchers will compare these two targets to see if higher feeding volumes prevent faltering growth without causing adverse metabolic outcomes.

Participants will:

• Have a feeding volume of 180-200 mL/kg/day or a volume of 140-160 mL/kg/day until 34 weeks corrected age

• Have four body composition assessments with a bioelectrical impedance analyzer throughout study period

• Have four stool samples collected throughout study period

• Have four maternal breastmilk samples collected and analyzed throughout the study period

• Have one blood sample collected at 36 weeks corrected age

• Have the option to participate in a follow-up survey completed by parents at 2-3 years of age ;

Related Conditions & MeSH terms

• Premature Birth
• Prematurity

• NCT number: NCT06420531
• Study type: Interventional
• Source: University of Alabama at Birmingham
• Contact: Ariel A. Salas, MD, MSPH
• Phone: 205-934-4680
• Email: asalas@uab.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2025
• Completion date: May 2030