Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The goal of the trial is to learn if targeted sodium supplementation (including blood and urine sodium testing) versus standard milk fortification (including blood sodium testing) improves growth and body composition in very preterm infants?
Eligibility
Participation Requirements
Sex: All
Maximum Age: 14 days
Healthy Volunteers: f
View:
• Admitted to the University of Washington, Oregon Health and Sciences, or University of Cincinnati NICU at 14 days of age
• Born between 24w0days and 31w6d
• Achieved full enteral feeding
Locations
United States
Ohio
University of Cincinnati
NOT_YET_RECRUITING
Cincinnati
Oregon
Oregon Health & Science University
NOT_YET_RECRUITING
Portland
Washington
University of Washington
RECRUITING
Seattle
Contact Information
Primary
John Feltner, MS
jfeltner@uw.edu
(206) 543-3200
Backup
Debbie Ng, MPH
ngdm@uw.edu
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 150
Treatments
Experimental: Targeted sodium supplementation
Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics.
Active_comparator: Enriched Milk Fortification
Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics.
Related Therapeutic Areas
Sponsors
Leads: University of Washington