NCT05380401 · The University of Texas Health Science Center at San Antonio
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
What this study is about
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
View original scientific description
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors.
Interventions
DIETARY_SUPPLEMENT
Enfamil® DHA & ARA Supplement for Special Dietary Use
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe
Primary outcome measures
Fatty acid levels in plasma
Time frame: Baseline to 36 weeks
Change in lipid metabolites reflected by levels in plasma
Fatty acid levels in red blood cell (RBC) membranes
Time frame: Baseline to 36 weeks
Change in fatty acid levels in RBC membranes
Change in circulating biomarker Lipoxin A4
Time frame: Baseline 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 D1
Time frame: Baseline 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 E1
Time frame: Baseline 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/Neuroprotectin
Time frame: Baseline to 36 weeks
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
- New Haven, Connecticut
- Chicago, Illinois
- New York, New York
- San Antonio, Texas
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2025 · Source of record for eligibility and locations