MedTrace Logo

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

NCT07562997 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-05-01

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Katie Strobel, MD, MSCR · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2029-06-01
Completion
2029-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07562997 on ClinicalTrials.gov