Metabolic Mechanisms Induced by Enteral Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA) Supplementation in Preterm Infants
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 8 months
Healthy Volunteers: f
View:
• 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.)
Locations
United States
California
University of California, Los Angeles (UCLA)
RECRUITING
Los Angeles
Connecticut
Yale New Haven Hospital
RECRUITING
New Haven
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Northwestern University
RECRUITING
Chicago
New York
Weill Cornell Medicine
RECRUITING
New York
Texas
University Health System
RECRUITING
San Antonio
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Cynthia Blanco, MD, MSCI-TS
blanco@uthscsa.edu
210-567-5225
Backup
Diana Anzueto Guerra
anzuetod@uthscsa.edu
210-567-5254
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2028-04
Participants
Target number of participants: 328
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center at San Antonio
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)