Recruiting

DHA & ARA

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05380401

Conditions

Premature

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Enfamil® DHA & ARA Supplement for Special Dietary Use

Study Details

Brief summary:

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.

Conditions

Premature

Study ID

NCT05380401

Start date

Mar 9, 2023

Status verified date

Sep, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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 Design

Enrollment

328 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: DHA/ARA supplement

DHA/ARA supplement throughout the duration of the protocol, "d-on"

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"

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"

Interventions

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 measure

  • Fatty acid levels in plasma [ Time Frame: Baseline to 36 weeks ]
  • Fatty acid levels in red blood cell (RBC) membranes [ Time Frame: Baseline to 36 weeks ]
  • Change in circulating biomarker Lipoxin A4 [ Time Frame: Baseline to 36 weeks ]
  • Change in biomarker Resolvin D1 [ Time Frame: Baseline to 36 weeks ]
  • Change in biomarker Resolvin E1 [ Time Frame: Baseline to 36 weeks ]
  • Change in Protectin/Neuroprotectin [ Time Frame: Baseline to 36 weeks ]

Central Contacts and Locations

Central contacts

Cynthia Blanco, MD, MSCI-TS

210-567-5225blanco@uthscsa.edu

Diana Anzueto Guerra

210-567-5254anzuetod@uthscsa.edu

Locations

University of California, Los Angeles (UCLA)

Recruiting

Los Angeles, California, United States, 90404

Contacts

Kara Calkins, MD

KCalkins@mednet.ucla.edu

Ashley Dong

AMDong@mednet.ucla.edu

Yale New Haven Hospital

Recruiting

New Haven, Connecticut, United States, 06511

Contacts

Sarah Taylor, MD

sarah.n.taylor@yale.edu

Tessa Kehoe

tessa.kehoe@yale.edu

Ann & Robert H. Lurie Children's Hospital of Chicago

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Daniel Robinson, MD

DTRobinson@luriechildrens.org

Jonah Silverglade

jsilverglade@luriechildrens.org

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Daniel Robinson, MD

DTRobinson@luriechildrens.org

Jonah Silverglade

jsilverglade@luriechildrens.org

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Camilia Martin, MD

camilia.martin@med.cornell.edu

Martha Liu

mal4038@med.cornell.edu

University Health System

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Diana Anzueto Guerra, MS

210-567-5254anzuetod@uthscsa.edu

Cynthia Blanco, MD

210-567-5225blanco@uthscsa.edu

Principal Investigator:

Cynthia L Blanco, MD

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Cynthia Blanco, MD

blanco@uthscsa.edu

Diana Anzueto Guerra

anzuetod@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Sep 24, 2025

Last verified

Sep, 2025

Keywords

  • infant, premature
  • fatty acids
  • nutrition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-09-24.