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.

NCT05380401

Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants

Recruiting
NAUp to 36InterventionalBasic science
The University of Texas Health Science Center at San Antonio
~328 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:Enfamil® DHA & ARA Supplement for Special Dietary Use

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fatty acid levels in plasma
Measured over Baseline to 36 weeks
+5 more outcomes measured
Premature

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.

  • Cynthia Blanco, MD, MSCI-TS · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio

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Eligibility criteria

Inclusion

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

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
  • 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.