Impact of DHA and ARA Supplementation on Preterm Infants
Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 328 (estimated) |
| Ages | N/A to 36 Weeks |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 7 sites (Los Angeles, California and 6 other locations) |
| Trial ID | NCT05380401 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born between 25 0/7 and 29 6/7 weeks of gestation.
Not a fit: Patients with serious congenital anomalies or those requiring immediate surgical intervention will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve metabolic health and developmental outcomes for preterm infants.
How similar studies have performed: Other studies have shown promising results with similar nutritional interventions in preterm infants, suggesting potential for success.
Eligibility criteria
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 this trial is running
Los Angeles, California and 6 other locations
- 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)
- 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
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.