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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
University of Washington
Study ID
NCT07562997
Status
Recruiting
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Conditions

  • Very Preterm and Extremely Preterm Birth

Eligibility Criteria

Sex
ALL
Age
0 Days - 14 Days
Healthy Volunteers
Not accepted

Interventions

  • Urine sodium testing — DIAGNOSTIC_TEST
    The investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated.
  • Serum sodium testing — DIAGNOSTIC_TEST
    The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
  • Milk fortification — DIETARY_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.

Study Details

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 Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Jun 1, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Targeted sodium supplementation
    Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics.
  • Active Comparator: Enriched Milk Fortification
    Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics.

Primary Outcome Measure

Body composition by point-of-care ultrasound [ Time Frame: Enrollment to study completion, on average 4-10 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45221
Ting Ting Fu, MD
[email protected]
513-636-4200
Oregon Health & Science UniversityPortlandOregon97239
Brian Scottoline, MD, PhD
[email protected]
(503) 494-8122
University of WashingtonSeattleWashington98195
Katie M Strobel, MD, MSCR
[email protected]
(206) 543-3200
D Taylor Hendrixson, MD, MPH (SUB_INVESTIGATOR)

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University of Cincinnati· Cincinnati, OHOregon Health & Science University· Portland, ORUniversity of Washington· Seattle, WA