RecruitingNot ApplicableNCT07562997

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


Sponsor

University of Washington

Enrollment

150 participants

Start Date

May 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 DaysMax Age: 14 Days

Inclusion Criteria3

  • 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 Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTUrine 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.

DIAGNOSTIC_TESTSerum sodium testing

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

DIETARY_SUPPLEMENTMilk 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.


Locations(3)

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Washington

Seattle, Washington, United States

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NCT07562997