Human Milk Concentrating Device to Optimize Mother's Own Milk (NEOMOM)
Noninferiority Evaluation of Human Milk Concentrating Device to Optimize Mother's Own Milk
This study is a randomized, non-inferiority clinical trial evaluating a human milk concentration (HMC) device in preterm infants. The trial compares outcomes in infants fed mother's own milk (MOM) concentrated using the HMC device to those receiving standard of care feeding with MOM supplemented with cow's milk-based fortifiers or formula.
The primary objective is to determine whether infants receiving HMC-concentrated MOM achieve growth and mineral status that are non-inferior to standard of care, as measured by growth velocity through 28 days of life or hospital discharge and serum phosphate levels at 14 days of life.
Secondary objectives include assessment of clinical safety through evaluation of feeding tolerance, weight gain, and serum chemistries during the study period. The study will also evaluate the cost and resource utilization associated with feeding strategies by comparing preparation time, supply costs, total feeding costs, and overall neonatal intensive care unit (NICU) cost of care, including length of stay.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Preterm infants often require nutritional supplementation to support adequate growth and bone mineralization during hospitalization. Current standard of care commonly involves the addition of cow's milk-based fortifiers or formula to mother's own milk (MOM), which may introduce variability in feeding practices, added cost, and exposure to non-human milk components.
This study evaluates a human milk concentration (HMC) device designed to increase the nutrient density of MOM through passive water removal using forward osmosis. The device enables concentration of MOM without the addition of bovine-derived products and is intended to integrate into existing neonatal intensive care unit (NICU) feeding workflows.
The study is a randomized, controlled, non-inferiority trial conducted in preterm infants receiving enteral nutrition in the NICU. Participants are assigned to receive either MOM concentrated using the HMC device or standard of care feeding consisting of MOM with supplementation per institutional practice. Feeding preparation and administration are performed according to site-specific protocols.
Clinical assessments are conducted throughout the study period to evaluate infant growth, nutritional status, and overall clinical stability. Safety monitoring includes routine clinical evaluations and laboratory assessments consistent with standard NICU care. In addition, data are collected to assess resource utilization and costs associated with feeding preparation and overall care during hospitalization.
The goal of this study is to generate evidence on whether concentrating MOM using the HMC device can provide a clinically comparable alternative to standard supplementation practices while potentially reducing reliance on bovine-derived products and impacting healthcare resource utilization.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Elizabeth Nelson, PhD
- Número de teléfono: 2679818066
- Correo electrónico: enelson@mmib.health
Ubicaciones de estudio
-
-
Connecticut
-
New Haven, Connecticut, Estados Unidos, 06511
- Yale University
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Birth at 32 0/7 to 34 5/7 weeks' gestational age, with a birthweight above 1500 grams and receiving MOM
- Enteral feeding must be initiated within 48 hours post-birth and the infant must meet the NICU's clinical guidelines for feed fortification/supplementation.
- Multiples are eligible and will be randomized to the same group since the intervention affects MOM preparation.
Exclusion Criteria:
- Major congenital anomalies
- Contraindication to receiving MOM
- Feeds not started by 2 days post-birth
- Fortification/supplementation not ordered by 5 days post-birth,
- Inadequate MOM for concentration/fortification within 5 days post-birth
- Expected transfer to another hospital
- Expected hospital discharge within 14 days post-birth
- Enrollment in another intervention study with an intervention that could affect infant growth or mineral status
- Infant with contraindications for use of the HMC device
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: HMC-Concentrated MOM
Preterm infants receive enteral feedings of mother's own milk that has been concentrated using the HMC device to increase nutrient density without the addition of bovine-derived fortifiers.
|
A sterile, single-use human milk concentration device used to passively remove water from mother's own milk prior to feeding, increasing nutrient density without the addition of bovine-derived fortifier.
|
|
Comparador activo: Standard Fortified Feeding (MOM + Fortifier/Formula)
Preterm infants receive enteral feedings of mother's own milk supplemented with cow's milk-based fortifier or formula according to institutional standard of care.
|
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Growth Velocity
Periodo de tiempo: Birth to 28 days of life or hospital discharge, whichever occurs first
|
Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
|
Birth to 28 days of life or hospital discharge, whichever occurs first
|
|
Serum Phosphate Level
Periodo de tiempo: 14 days of life
|
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
|
14 days of life
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feeding Tolerance
Periodo de tiempo: Up to 28 days of life or hospital discharge
|
Clinical assessment of feeding tolerance based on physical examination and incidence of feeding intolerance events during the study period.
|
Up to 28 days of life or hospital discharge
|
|
Weight Gain Monitoring
Periodo de tiempo: Daily through 28 days of life or discharge
|
Serial assessment of infant weight to evaluate adequacy of growth during the study period.
|
Daily through 28 days of life or discharge
|
|
Feeding Preparation Cost
Periodo de tiempo: Up to 28 days of life or discharge
|
Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
|
Up to 28 days of life or discharge
|
|
Total Feeding Cost
Periodo de tiempo: First 28 days of life or until discharge
|
Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
|
First 28 days of life or until discharge
|
|
Length of Stay
Periodo de tiempo: From birth to hospital discharge (up to 10 weeks)
|
Duration of hospitalization in the NICU.
|
From birth to hospital discharge (up to 10 weeks)
|
|
Total NICU cost of care
Periodo de tiempo: From birth to hospital discharge (up to 10 weeks)
|
Total hospital costs incurred during NICU stay, including all resources utilized.
|
From birth to hospital discharge (up to 10 weeks)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sarah Taylor, MD, Yale University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MMIB-NEOMOM-2000042290
- R44HD110306 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
IPD Description:
De-identified individual participant data underlying the results reported in this study, including baseline characteristics and outcome measures, may be shared.
Access Criteria:
Data will be made available to qualified researchers upon reasonable request, subject to review and approval by the study sponsor. Access will require a data use agreement and must comply with applicable privacy and regulatory requirements.
Marco de tiempo para compartir IPD
Criterios de acceso compartido de 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Human Milk Concentration Device
-
KK Women's and Children's HospitalActivo, no reclutandoFalta de crecimiento | Lactante de muy bajo peso al nacer | Leche Materna de DonanteSingapur
-
Columbia UniversityReclutamientoFalta de crecimiento | Retraso del crecimiento | Precocidad; Extremo | Trastornos de la nutrición infantil | Falta de crecimiento en el recién nacidoEstados Unidos