Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants (SAFE)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Debbie Ng, MPH
- E-mail: ngdm@uw.edu
Sauvegarde des contacts de l'étude
- Nom: John Feltner, MS
- Numéro de téléphone: (206) 543-3200
- E-mail: jfeltner@uw.edu
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45221
- Pas encore de recrutement
- University of Cincinnati
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Contact:
- Ting Ting Fu, MD
- Numéro de téléphone: 513-636-4200
- E-mail: futn@ucmail.uc.edu
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Oregon
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Portland, Oregon, États-Unis, 97239
- Pas encore de recrutement
- Oregon Health & Science University
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Contact:
- Brian Scottoline, MD, PhD
- Numéro de téléphone: (503) 494-8122
- E-mail: scottoli@ohsu.edu
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Washington
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Seattle, Washington, États-Unis, 98195
- Recrutement
- University of Washington
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Contact:
- Katie M Strobel, MD, MSCR
- Numéro de téléphone: (206) 543-3200
- E-mail: kmstrob@uw.edu
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Sous-enquêteur:
- D Taylor Hendrixson, MD, MPH
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Targeted sodium supplementation
Every two weeks serum sodium and urine sodium testing with sodium supplementation if indicated by algorithm.
Milk fortification per growth metrics.
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The investigators will utilize urine sodium testing every two weeks in conjunction with serum sodium testing to determine if sodium supplementation is indicated.
The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.
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Comparateur actif: Enriched Milk Fortification
Serum sodium testing every two weeks with sodium supplementation if indicated by clinical team.
Milk fortification per growth metrics.
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The investigators will use serum sodium testing to determine if sodium supplementation or adjustments to sodium supplementation need to be made.
The investigators will provide milk fortification using either a bovine-based or a human-milk-based fortifier (per unit protocol), based on growth trajectories.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Body composition by point-of-care ultrasound
Délai: Enrollment to study completion, on average 4-10 weeks
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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.
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Enrollment to study completion, on average 4-10 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Body composition using air-displacement plethysmography
Délai: At study completion, on average 4-10 weeks
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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.
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At study completion, on average 4-10 weeks
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anthropometric growth
Délai: Enrollment to study completion, on average 4-10 weeks
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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
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Enrollment to study completion, on average 4-10 weeks
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Adverse outcomes
Délai: Enrollment to hospital discharge, on average between 4 to 16 weeks
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The study team will evaluate adverse outcome rates such as bronchopulmonary dysplasia, necrotizing enterocolitis, and all-cause mortality.
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Enrollment to hospital discharge, on average between 4 to 16 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Katie Strobel, MD, MSCR, University of Washington
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- STUDY00023657
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Type d'informations de prise en charge du partage d'IPD
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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