Sodium and Milk Fortification Evaluation of Body Composition Among Very Preterm Infants (SAFE)
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Debbie Ng, MPH
- Correo electrónico: ngdm@uw.edu
Copia de seguridad de contactos de estudio
- Nombre: John Feltner, MS
- Número de teléfono: (206) 543-3200
- Correo electrónico: jfeltner@uw.edu
Ubicaciones de estudio
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45221
- Aún no reclutando
- University of Cincinnati
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Contacto:
- Ting Ting Fu, MD
- Número de teléfono: 513-636-4200
- Correo electrónico: futn@ucmail.uc.edu
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- Aún no reclutando
- Oregon Health & Science University
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Contacto:
- Brian Scottoline, MD, PhD
- Número de teléfono: (503) 494-8122
- Correo electrónico: scottoli@ohsu.edu
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Washington
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Seattle, Washington, Estados Unidos, 98195
- Reclutamiento
- University of Washington
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Contacto:
- Katie M Strobel, MD, MSCR
- Número de teléfono: (206) 543-3200
- Correo electrónico: kmstrob@uw.edu
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Sub-Investigador:
- D Taylor Hendrixson, MD, MPH
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body composition by point-of-care ultrasound
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Body composition using air-displacement plethysmography
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Anthropometric growth
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Katie Strobel, MD, MSCR, University of Washington
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00023657
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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