A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: Newborn
Maximum Age: 4 days
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Mississippi
University of Mississippi Medical Center
NOT_YET_RECRUITING
Jackson
Texas
University of Texas Southwestern Medical Center at Dallas
NOT_YET_RECRUITING
Dallas
University of Texas Health Science Center at Houston
NOT_YET_RECRUITING
Houston
Contact Information
Primary
Ariel A. Salas, MD, MSPH
asalas@uab.edu
205-934-4680
Time Frame
Start Date: 2025-09-16
Estimated Completion Date: 2030-08-30
Participants
Target number of participants: 486
Treatments
Experimental: Intervention: 180-200 mL/kg/day of human milk
Study participants randomized to the intervention group will receive 180-200 mL/kg/day of human milk for 34 weeks corrected age.
Placebo_comparator: Control:140-160 mL/kg/day of human milk
Study participants randomized to the control group will receive 140-160 mL/kg/day of human milk for 34 weeks corrected age.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham