An interventional study of Enfamil® DHA & ARA Supplement for Special Dietary Use in Premature, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 7 sites in United States. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Basic science
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.
Infants will be randomized to receive the combined enteral DHA/ARA supplement within the first 48 hours after birth to 36 weeks postmenstrual age. The randomization procedure will follow a stratified permuted block scheme to fulfill two goals: (1) randomize infants into one of four arms and (2) ensure an adequate sample size within each week of gestational age. Preterm infants will be randomized using random permuted blocks within each of the 5 birth gestational age strata. When treatment assignment is open and sample size is not overtly large, a block randomization procedure with randomly chosen block sizes can maintain treatment assignment balance and reduce the potential for selection bias. This approach will also ensure that preterm infants of all eligible gestational ages at birth are approximately equally represented in each of 4 arms of the trial, thus ensuring that important comorbidities and standard of care applicable to infants of different gestational ages at birth are also approximately equally distributed across the study arms. There is no placebo for this study. There is no blinding in this study. Consent will also be obtained from the mother of the infant, as they will be asked to provide milk samples if they're breastfeeding their infant, and maternal medical history and demographical data will be recorded.
2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.
This study's planned enrollment of 328 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DHA/ARA supplement throughout the duration of the protocol, "d-on"
Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use
no DHA/ARA supplement throughout the duration of the protocol, "d-off"
DHA/ARA supplement from enrollment to 31 6/7 weeks post-menstrual age (PMA) then no supplement from 32 to 36 weeks' PMA, "x- on/off"
Dietary Supplement: Enfamil® DHA & ARA Supplement for Special Dietary Use
No DHA/ARA supplement till 31 6/7 weeks' then long-chain polyunsaturated fatty acids (LCPUFA) supplement from 32 to 36 weeks PMA, "x-off/on"
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
Also known as: DHA/ARA Supplement
Fatty acid levels in plasma
Change in lipid metabolites reflected by levels in plasma
Time frame: Baseline to 36 weeks
Fatty acid levels in red blood cell (RBC) membranes
Change in fatty acid levels in RBC membranes
Time frame: Baseline to 36 weeks
Change in circulating biomarker Lipoxin A4
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Time frame: Baseline to 36 weeks
Change in biomarker Resolvin D1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Time frame: Baseline to 36 weeks
Change in biomarker Resolvin E1
Biomarker reflective of system development and function will be measured. There are no specific levels since there is no normative data in neonates.
Time frame: Baseline to 36 weeks
Change in Protectin/Neuroprotectin
Levels of protectin/neuroprotectin and fatty acids in the n3 and n6 pathways will be measured.
Time frame: Baseline to 36 weeks
Change in infant weigh
Recorded in grams (ounces)
Time frame: Baseline to 36 weeks
Bronchopulmonary dysplasia (BDP)
Percentage of participants with BDP
Time frame: Baseline to 36 weeks
Late-onset sepsis (LOS)
Percentage of participants with LOS
Time frame: Baseline to 36 weeks
Retinopathy of prematurity (ROP)
Percentage of participants with ROP
Time frame: Baseline to 36 weeks
Necrotizing enterocolitis (NEC)
Percentage of participants with NEC
Time frame: Baseline to 36 weeks
Plan to share: Yes — Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The University of Texas Health Science Center at San Antonio