Sodium-guided Fortification for growth in very preterm infants
Official title: Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants
Run by University of Washington · NCT07562997 · Data updated 2026-11-12
In very preterm babies, this study tests whether guiding milk fortification with urine and blood sodium tests helps them grow and gain lean mass better than standard fortified milk.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Days to 14 Days |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 3 sites (Cincinnati, Ohio and 2 other locations) |
| Status | Recruiting |
| Started | May 18, 2026 |
| Main results expected | June 1, 2029 |
| Study ends | October 31, 2029 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07562997 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born between 24+0 and 31+6 weeks gestation, admitted to participating NICUs, and who have achieved full enteral feeding.
✕Probably not a fit
Infants with congenital anomalies affecting growth, significant renal dysfunction, NEC grade 2 or higher, limited NICU stay, or enrollment in conflicting interventional studies may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares a urine sodium-guided supplementation protocol with the standard enriched fortification approach in very preterm infants. Starting around day 14 of life and continuing until about 38 weeks postmenstrual age, researchers monitor urine and serum sodium to tailor electrolyte and fortification needs. The goal is to improve body growth and lean mass by addressing early sodium depletion due to immature kidney function. Outcomes include anthropometric measures and body composition assessments. The trial is conducted across three NICUs with predefined inclusion and exclusion criteria.
Why it matters
Potential benefit: If successful, the approach could improve growth and lean mass in very preterm infants by optimizing sodium balance.
How similar studies have gone: Urine sodium-guided approaches have shown potential in identifying sodium depletion earlier than serum testing, with some prospective data supporting improved growth signals, but this specific protocol is novel in validating body composition outcomes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
University of Washington
Seattle, Washington, United States Recruiting -
University of Cincinnati
Cincinnati, Ohio, United States Not yet recruiting -
Oregon Health & Science University
Portland, Oregon, United States Not yet recruiting
Study contacts
- Principal investigator: Katie Strobel, MD, MSCR — University of Washington
- Study coordinator: John Feltner, MS
- Email: jfeltner@uw.edu
- Phone: (206) 543-3200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.