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

September 19, 2025 updated by: The University of Texas Health Science Center at San Antonio

Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

328

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: DHA/ARA supplement
DHA/ARA supplement throughout the duration of the protocol, "d-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
Other Names:
  • DHA/ARA Supplement
No Intervention: No DHA/ARA supplement
no DHA/ARA supplement throughout the duration of the protocol, "d-off"
Other: DHA/ARA initially then no supplement
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
Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe
Other Names:
  • DHA/ARA Supplement
Other: No supplement initially then DHA/ARA supplement
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
Other Names:
  • DHA/ARA Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fatty acid levels in plasma
Time Frame: Baseline to 36 weeks
Change in lipid metabolites reflected by levels in plasma
Baseline to 36 weeks
Fatty acid levels in red blood cell (RBC) membranes
Time Frame: Baseline to 36 weeks
Change in fatty acid levels in RBC membranes
Baseline to 36 weeks
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.
Baseline to 36 weeks
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.
Baseline to 36 weeks
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.
Baseline to 36 weeks
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.
Baseline to 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in infant weigh
Time Frame: Baseline to 36 weeks
Recorded in grams (ounces)
Baseline to 36 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bronchopulmonary dysplasia (BDP)
Time Frame: Baseline to 36 weeks
Percentage of participants with BDP
Baseline to 36 weeks
Late-onset sepsis (LOS)
Time Frame: Baseline to 36 weeks
Percentage of participants with LOS
Baseline to 36 weeks
Retinopathy of prematurity (ROP)
Time Frame: Baseline to 36 weeks
Percentage of participants with ROP
Baseline to 36 weeks
Necrotizing enterocolitis (NEC)
Time Frame: Baseline to 36 weeks
Percentage of participants with NEC
Baseline to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Cynthia Blanco, MD, MSCI-TS, University of Texas Health Science Center San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2023

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20220120H
  • 1R01HD108646 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified data will be shared with the funding body, NIH, summary results will be shared in ClinicalTrials.gov

IPD Sharing Time Frame

Data will be shared at completion of the study when data analysis has occure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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