Not Yet RecruitingNot Applicable

Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants

United States150 participantsStarted 2026-06-01

Plain-language 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?

Who can participate

Age range0 Days – 14 Days

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Congenital or chromosomal anomalies affecting growth * Acute renal insufficiency (KDIGO stage 1 or higher) * Necrotizing enterocolitis (modified Bell's stage IIA or higher) * Anticipated NICU stay less than 30 days * Enrollment in a concurrent interventional study that may confound study outcomes

What they're measuring

Body composition by point-of-care ultrasound

Timeframe: Enrollment to study completion, on average 4-10 weeks

Trial details

NCT IDNCT07562997

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-06-01

Contact for this trial

John Feltner, MS

(206) 543-3200 jfeltner@uw.edu

View on ClinicalTrials.gov More Very Preterm and Extremely Preterm Birth trials