Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
NCT ID: NCT05380401
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
328 participants
INTERVENTIONAL
2023-03-09
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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DHA/ARA supplement
DHA/ARA supplement throughout the duration of the protocol, "d-on"
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
No DHA/ARA supplement
no DHA/ARA supplement throughout the duration of the protocol, "d-off"
No interventions assigned to this group
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"
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
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"
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
36 Weeks
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Cynthia Blanco, MD, MSCI-TS
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center San Antonio
Locations
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University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Northwestern University
Chicago, Illinois, United States
Weill Cornell Medicine
New York, New York, United States
University Health System
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HSC20220120H
Identifier Type: -
Identifier Source: org_study_id
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