Effect of human milk diets on growth in preterm infants
A Multicenter Randomized Clinical Trial Comparing Two Human Milk Volumes to Optimize Growth and Gut Health in Infants Born Very Preterm
This study is testing if giving moderately preterm infants more human milk can help them grow better without causing any health issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 486 (estimated) |
| Ages | 6 Hours to 4 Days |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT06420531 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized trial aims to evaluate the impact of different volumes of human milk diets on the growth outcomes of moderately preterm infants born between 27 and 31 weeks of gestation. Participants will be assigned to receive either 140-160 mL/kg/day or 180-200 mL/kg/day of human milk, with adjustments made by clinicians as needed until they reach 34 weeks postmenstrual age. The study will involve multiple assessments of body composition, stool, and breastmilk samples, as well as a blood sample at 36 weeks corrected age. The goal is to determine if higher feeding volumes can prevent growth faltering without adverse metabolic effects.
Who should consider this trial
Good fit: Ideal candidates are infants born between 27 and 31 weeks of gestation with a birthweight of 1500 grams or less who are fed human milk during the first 14 days after birth.
Not a fit: Patients with severe gastrointestinal complications or major congenital anomalies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve growth outcomes for preterm infants, potentially leading to better long-term health.
How similar studies have performed: Other studies have shown promising results with human milk diets in preterm infants, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, United States (Not_yet_recruiting)
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (Not_yet_recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Ariel A. Salas, MD, MSPH — UAB Hospital
- Study coordinator: Ariel A. Salas, MD, MSPH
- Email: asalas@uab.edu
- Phone: 205-934-4680
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.