DHA and ARA Supplementation for Premature Infants
This study is looking at how giving premature infants a supplement called Enfamil® DHA & ARA affects their bodies. Specifically, researchers want to understand how this supplement impacts their lipid (fat) metabolism, inflammation, and organ development. You might be able to join if your baby was born very prematurely (between 25 weeks and 29 weeks and 6 days of pregnancy) and is less than 48 hours old. The study will measure levels of fatty acids in your baby's blood and red blood cells, and a marker for inflammation (Lipoxin A4), from when they start the supplement until they reach 36 weeks post-menstrual age. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 328 premature infants. Infants will be randomly assigned to one of four groups to receive the Enfamil® DHA & ARA supplement, and there is no blinding or placebo group.
- What's involved
- Infants will receive the Enfamil® DHA & ARA supplement through an enteral tube or oral syringe from within 48 hours after birth until 36 weeks post-menstrual age. If you are breastfeeding, you will be asked to provide milk samples, and your medical history and demographic information will be recorded.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your baby's fatty acid levels and a biomarker will be measured from the start of the study until they reach 36 weeks post-menstrual age.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
At a glance
Conditions
NCT05380401
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinoisstudy coordinator listed
Recruiting
Northwestern University
Chicago, Illinoisstudy coordinator listed
Recruiting
University Health System
San Antonio, Texasstudy coordinator listed
Recruiting
University of California, Los Angeles (UCLA)
Los Angeles, Californiastudy coordinator listed
Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texasstudy coordinator listed
Recruiting
Weill Cornell Medicine
New York, New Yorkstudy coordinator listed
Recruiting
Yale New Haven Hospital
New Haven, Connecticutstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Cynthia Blanco, MD, MSCI-TS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
Who to contact
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Inclusion
Exclusion
What this trial measures
- Fatty acid levels in plasmaBaseline to 36 weeks
Change in lipid metabolites reflected by levels in plasma
- Fatty acid levels in red blood cell (RBC) membranesBaseline to 36 weeks
Change in fatty acid levels in RBC membranes
- Change in circulating biomarker Lipoxin A4Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
- Change in biomarker Resolvin D1Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
- Change in biomarker Resolvin E1Baseline to 36 weeks
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
- Change in Protectin/NeuroprotectinBaseline to 36 weeks
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.