Effect of human milk diets on growth in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Texas Southwestern Medical Center at Dallas
  Dallas, Texas, United States Recruiting
• University of Texas Health Science Center at Houston
  Houston, Texas, United States Recruiting
• University of Mississippi Medical Center
  Jackson, Mississippi, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.