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RECRUITING
NCT07562997
NA

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

Sponsor: University of Washington

View on ClinicalTrials.gov

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?

Key Details

Gender

All

Age Range

0 Days - 14 Days

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-05-18

Completion Date

2029-10-31

Last Updated

2026-05-28

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Serum sodium testing

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

DIETARY_SUPPLEMENT

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.

Locations (3)

University of Cincinnati

Cincinnati, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Washington

Seattle, Washington, United States