Impact of DHA and ARA Supplementation on Preterm Infants
Official title: Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
Run by The University of Texas Health Science Center at San Antonio · NCT05380401 · Data updated 2026-11-12
This study tests if giving preterm infants a supplement of DHA and ARA right after birth can help improve their fat metabolism as they grow.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 36 Weeks |
| Sex | All |
| Enrollment | 328 (estimated) |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Status | Recruiting |
| Started | March 9, 2023 |
| Main results expected | April 2027 |
| Study ends | April 2028 |
| Registry record updated | October 7, 2026 |
| Trial ID | NCT05380401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born between 25 0/7 and 29 6/7 weeks of gestation.
✕Probably not a fit
Patients with serious congenital anomalies or those requiring immediate surgical intervention will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates how enteral supplementation of DHA and ARA affects lipid metabolism in preterm infants. Infants born between 25 and 29 weeks of gestation will be randomly assigned to receive the supplement within the first 48 hours after birth and monitored until 36 weeks postmenstrual age. The randomization will ensure a balanced representation of different gestational ages and associated comorbidities. Maternal consent will be obtained for participation, and breastfeeding mothers may provide milk samples for analysis.
Why it matters
Potential benefit: If successful, this study could improve metabolic health and developmental outcomes for preterm infants.
How similar studies have gone: Other studies have shown promising results with similar nutritional interventions in preterm infants, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * born between 25 0/7 and 29 6/7 weeks of gestation * less than 48 hours of age at first lipid dose (The cohort is defined by gestational age rather than birth weight to avoid an over-represented sample of growth-restricted infants in birth weight defined cohorts.) Exclusion Criteria: * serious congenital anomalies * conditions at birth that will require surgery prior to discharge * imminent death such that withdrawal of intensive care support is anticipated within the first 72 hours after birth
Where it's running
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University of California, Los Angeles (UCLA)
Los Angeles, California, United States Recruiting -
Yale New Haven Hospital
New Haven, Connecticut, United States Recruiting -
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Recruiting -
Northwestern University
Chicago, Illinois, United States Recruiting -
Weill Cornell Medicine
New York, New York, United States Recruiting -
University Health System
San Antonio, Texas, United States Recruiting
Show 1 more location
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States Recruiting
Study contacts
- Principal investigator: Cynthia Blanco, MD, MSCI-TS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Cynthia Blanco, MD, MSCI-TS
- Email: blanco@uthscsa.edu
- Phone: 210-567-5225
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.