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

23. maj 2026 opdateret af: Katie Strobel, University of Washington
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?

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Very preterm infants (born <32 weeks gestational age) are at high risk for postnatal growth faltering, which is associated with adverse neurodevelopmental outcomes. Despite routine use of enriched human milk fortification in the NICU, many infants fail to achieve adequate somatic and lean mass growth. Sodium depletion has been identified as a potentially modifiable contributor to this problem: renal tubular immaturity in preterm infants results in obligate urinary sodium wasting. Total body sodium depletion has been associated with poor growth in infants and poor muscle mass development in animal studies.

Current NICU practice relies primarily on serum sodium to guide supplementation; however, serum sodium is a late and insensitive marker of total body sodium depletion. Urine sodium is a more sensitive indicator of sodium balance and may identify depletion before serum levels fall. Gestational-age-specific urine sodium thresholds to guide supplementation have recently been proposed (Stalter et al., 2025), but have evaluated body composition in a prospective randomized trial.

This trial tests whether a structured, urine sodium-guided supplementation protocol based on every other week urine and serum sodium monitoring improves anthropometric growth and lean mass accrual compared to standard enriched fortification alone. The intervention runs from day of life 14 through 36 weeks postmenstrual age, with tapering through 38 weeks PMA.

Body composition assessment incorporates two complementary modalities: serial point-of-care ultrasound (POCUS) of the biceps, rectus femoris, and subcutaneous fat for longitudinal lean and fat mass tracking, and Air Displacement Plethysmography (PeaPod) at 36 weeks postmenstrual age or discharge for criterion-standard whole-body composition. Fat mass, fat-free mass, and body fat percentage will be referenced against the Norris et al. preterm normative curves.

The trial uses an open-label design with block randomization stratified by gestational age. A Data Safety and Monitoring Board will conduct oversight and interim safety reviews.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

150

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: John Feltner, MS
  • Telefonnummer: (206) 543-3200
  • E-mail: jfeltner@uw.edu

Studiesteder

  • Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45221
        • Ikke rekrutterer endnu
        • University of Cincinnati
        • Kontakt:
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Ikke rekrutterer endnu
        • Oregon Health & Science University
        • Kontakt:
    • Washington
      • Seattle, Washington, Forenede Stater, 98195
        • Rekruttering
        • University of Washington
        • Kontakt:
          • Katie M Strobel, MD, MSCR
          • Telefonnummer: (206) 543-3200
          • E-mail: kmstrob@uw.edu
        • Underforsker:
          • D Taylor Hendrixson, MD, MPH

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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 Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Targeted sodium supplementation
Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm. Milk fortification per growth metrics.
Diagnostisk 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.
Diagnostisk 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.
Kosttilskud: 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.
Aktiv komparator: Enriched Milk Fortification
Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team. Milk fortification per growth metrics.
Diagnostisk 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body composition by point-of-care ultrasound
Tidsramme: Enrollment 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.
Enrollment to study completion, on average 4-10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Body composition using air-displacement plethysmography
Tidsramme: At study completion, on average 4-10 weeks
We will conduct air-displacement plethysmography when the infant is off of oxygen at 36 weeks postmenstrual age or prior to discharge, whichever comes earlier.
At study completion, on average 4-10 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anthropometric growth
Tidsramme: Enrollment to study completion, on average 4-10 weeks
The clinical team measures weight, length, and head circumference z-scores weekly during hospitalization. The investigators will evaluate the change in z-score from birth to 36 weeks postmenstrual age
Enrollment to study completion, on average 4-10 weeks
Adverse outcomes
Tidsramme: Enrollment to hospital discharge, on average between 4 to 16 weeks
The study team will evaluate adverse outcome rates such as bronchopulmonary dysplasia, necrotizing enterocolitis, and all-cause mortality.
Enrollment to hospital discharge, on average between 4 to 16 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Washington

Efterforskere

  • Ledende efterforsker: Katie Strobel, MD, MSCR, University of Washington

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

18. maj 2026

Primær færdiggørelse (Anslået)

1. juni 2029

Studieafslutning (Anslået)

31. oktober 2029

Datoer for studieregistrering

Først indsendt

31. marts 2026

Først indsendt, der opfyldte QC-kriterier

28. april 2026

Først opslået (Faktiske)

1. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00023657

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

We anticipate this data would be available October 2030 and would be available untl 2040.

IPD-deling Understøttende informationstype

  • CSR

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produkt fremstillet i og eksporteret fra U.S.A.

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