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Sodium and Milk Fortification for Very Preterm Infants

This study is looking at whether a special way of giving sodium (salt) to very preterm infants helps them grow better. Researchers will use urine sodium testing along with regular blood (serum) sodium testing to decide if and how much sodium supplementation is needed. This is compared to the usual way of giving milk fortification, which only uses blood sodium testing. The goal is to see if this targeted approach improves how much infants grow and their body composition (how much lean muscle they have). You might be able to join if your baby was born very preterm (between 24 weeks and 31 weeks, 6 days of pregnancy), is 0 to 14 days old, and is admitted to a specific NICU (University of Washington, Oregon Health and Sciences, or University of Cincinnati). The study is currently unclear on its recruitment status.

Study design
This is an interventional study planning to enroll 150 very preterm infants. It compares two different ways of providing nutrition and sodium.
What's involved
Your baby would have urine and serum sodium testing every two weeks. Milk fortification would be provided based on their growth.
Compensation
Not stated in the trial record.
Follow-up
Body composition will be measured from enrollment until the study ends, which is typically 4-10 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07562997

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

Recruiting
NAAges 0–14InterventionalTreatment
University of Washington
~150 participants
Updated 2026-05-28 on ClinicalTrials.gov
What's tested:Urine sodium testingSerum sodium testingMilk fortification

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Body composition by point-of-care ultrasound
Measured over Enrollment to study completion, on average 4-10 weeks

Conditions

Very Preterm and Extremely Preterm Birth

Explore related trials

Preterm Birth

Where it's being run

3 sites across 3 states
Ohio1
Oregon1
Washington1

Study leadership

  • Katie Strobel, MD, MSCR · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

John Feltner, MS
[email protected]
(206) 543-3200
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Body composition by point-of-care ultrasoundEnrollment to study completion, on average 4-10 weeks

    Evaluate muscle and subcutaneous fat accretion from enrollment to 36 weeks posmtnestrual age. The study team will perform biceps and rectus femoris cross-sectional area measurements using point-of-care ultrasound every 2 weeks. We will perform arm and mid-thigh subcutaneous fat measurements using point-of-care ultrasound every 2 weeks.