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

Part of paid clinical trials in Los Angeles, California.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05380401
Status
Recruiting
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Conditions

  • Premature

Eligibility Criteria

Sex
ALL
Age
N/A - 36 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Enfamil® DHA & ARA Supplement for Special Dietary Use — DIETARY_SUPPLEMENT
    Dosage: 60 mg/kg/day of DHA and 120 mg/kg/day of ARA. Route of administration: enteral tube or by oral syringe

Study Details

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.

Key Dates

Start date
Mar 9, 2023
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2028

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

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"

Primary Outcome Measure

Fatty acid levels in plasma [ Time Frame: Baseline to 36 weeks ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
University of California, Los Angeles (UCLA)Los AngelesCalifornia90404
Kara Calkins, MD
[email protected]
Ashley Dong
[email protected]
Yale New Haven HospitalNew HavenConnecticut06511
Sarah Taylor, MD
[email protected]
Tessa Kehoe
[email protected]
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Daniel Robinson, MD
[email protected]
Jonah Silverglade
[email protected]
Northwestern UniversityChicagoIllinois60611
Daniel Robinson, MD
[email protected]
Jonah Silverglade
[email protected]
Weill Cornell MedicineNew YorkNew York10021
Camilia Martin, MD
[email protected]
Martha Liu
[email protected]
University Health SystemSan AntonioTexas78229
Diana Anzueto Guerra, MS
[email protected]
210-567-5254
Cynthia Blanco, MD
[email protected]
210-567-5225
Cynthia L Blanco, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Cynthia Blanco, MD
[email protected]
Diana Anzueto Guerra
[email protected]

Find similar trials in Los Angeles, CA

By research site
University of California, Los Angeles (UCLA)· Los Angeles, CAYale New Haven Hospital· New Haven, CTAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILNorthwestern University· Chicago, ILWeill Cornell Medicine· New York, NYUniversity Health System· San Antonio, TX

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