Actively Recruiting
Early DHA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Led by University of Alabama at Birmingham · Updated on 2026-05-08
152
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
U
University of Alabama at Birmingham
Lead Sponsor
M
Mead Johnson Nutrition
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of early docosahexaenoic acid (DHA) supplementation in very preterm infants who have restricted growth and low fat mass. These infants often have low DHA levels that decline further during the first three weeks after birth due to current feeding and lipid supplementation practices. The study aims to see if giving DHA through enteral supplementation early on can improve head growth without negatively impacting fat mass in these vulnerable infants. In this randomized clinical trial, 152 very preterm infants will be assigned to one of two groups. One group will receive a DHA/arachidonic acid (ARA) supplement added to expressed or donor human milk during the first three weeks after birth. The other group will receive human milk without the DHA/ARA supplement. The study uses a quadruple masking approach to compare these two feeding strategies during this critical early period. Participants will be monitored from birth until 36 weeks postmenstrual age or discharge. Researchers will measure head circumference as the primary outcome and assess fat mass-for-age Z-scores and changes in serum metabolic profiles as secondary outcomes. This thorough monitoring will help determine how early DHA supplementation affects growth and metabolism in these infants over the study period.
CONDITIONS
Brief Title
Early DHA/ARA Supplementation in Growth-restricted Very Preterm Infants: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational ages between 22 0/7 and 32 6/7 weeks
- Birthweight below the 25th percentile
You will not qualify if you...
- Major congenital or chromosomal anomalies
- Terminal illness with decisions to withhold or limit support made
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - First 3 weeks after birth
Participants receive a DHA/ARA supplement added to expressed or donor human milk during the first 3 weeks after birth or no supplement in the control group.
Duration - Until 36 weeks postmenstrual age or discharge
Participants are monitored until 36 weeks postmenstrual age or discharge to assess growth and metabolic outcomes.
Trial Site Locations
Total: 1 location
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Actively Recruiting
Research Team
A
Ariel A Salas, MD, MSPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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