Status:
RECRUITING
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Premature
Eligibility:
All Genders
Up to 36 years
Phase:
NA
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 biol...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT05380401
Start Date
March 9 2023
End Date
April 1 2028
Last Update
September 24 2025
Active Locations (7)
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1
University of California, Los Angeles (UCLA)
Los Angeles, California, United States, 90404
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06511
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Northwestern University
Chicago, Illinois, United States, 60611