Recruiting

Sodium Supplementation vs. Milk Fortification

Sponsor:

University of Washington

Code:

NCT07562997

Conditions

Very Preterm and Extremely Preterm Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Urine sodium testing

Serum sodium testing

Milk fortification

Study Details

Brief 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?

Conditions

Very Preterm and Extremely Preterm Birth

Study ID

NCT07562997

Start date

May 18, 2026

Status verified date

May, 2026

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Urine sodium testing

The investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated.

Serum sodium testing

The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.

Milk fortification

The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.

Primary outcome measure

  • Body composition by point-of-care ultrasound [ Time Frame: Enrollment to study completion, on average 4-10 weeks ]

Central Contacts and Locations

Central contacts

John Feltner, MS

(206) 543-3200jfeltner@uw.edu

Debbie Ng, MPH

ngdm@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Katie M Strobel, MD, MSCR

(206) 543-3200kmstrob@uw.edu

More Information

Sponsor

University of Washington

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

  • growth
  • body composition
  • sodium monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-28.