NCT07562997

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?

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
42mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

March 31, 2026

Last Update Submit

April 28, 2026

Conditions

Very Preterm and Extremely Preterm Birth

Keywords

growthbody compositionsodium monitoring

Outcome Measures

Primary Outcomes (1)

  • Body composition by point-of-care ultrasound

    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.

    Enrollment to study completion, on average 4-10 weeks

Secondary Outcomes (1)

  • Body composition using air-displacement plethysmography

    At study completion, on average 4-10 weeks

Other Outcomes (2)

  • Anthropometric growth

    Enrollment to study completion, on average 4-10 weeks

  • Adverse outcomes

    Enrollment to hospital discharge, on average between 4 to 16 weeks

Study Arms (2)

Targeted sodium supplementation

EXPERIMENTAL

Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics.

Diagnostic Test: Urine sodium testingDiagnostic Test: Serum sodium testingDietary Supplement: Milk fortification

Enriched Milk Fortification

ACTIVE COMPARATOR

Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics.

Diagnostic Test: Serum sodium testingDietary Supplement: Milk fortification

Interventions

Milk fortificationDIETARY_SUPPLEMENT

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

Enriched Milk FortificationTargeted sodium supplementation
Urine sodium testingDIAGNOSTIC_TEST

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

Targeted sodium supplementation
Serum sodium testingDIAGNOSTIC_TEST

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

Enriched Milk FortificationTargeted sodium supplementation

Eligibility Criteria

Age0 Days - 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

  • Katie Strobel, MD, MSCR

    University of Washington

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Feltner, MS

CONTACT

(206) 543-3200jfeltner@uw.edu

Debbie Ng, MPH

CONTACT

ngdm@uw.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor: Pediatrics

Study Record Dates

First Submitted

March 31, 2026

First Posted

May 1, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Once the study and planned analyses are complete, we will submit de-identified participant data to a public database such as Zenodo.

Shared Documents
CSR
Time Frame
We anticipate this data would be available October 2030 and would be available untl 2040.

Locations

US(3)