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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Elizabeth Nelson, PhD
- Numéro de téléphone: 2679818066
- E-mail: enelson@mmib.health
Lieux d'étude
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Connecticut
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New Haven, Connecticut, États-Unis, 06511
- Yale University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
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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.
|
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Comparateur actif: 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.
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Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Growth Velocity
Délai: Birth to 28 days of life or hospital discharge, whichever occurs first
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Average daily weight gain normalized to body weight in preterm infants receiving assigned feeding strategy.
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Birth to 28 days of life or hospital discharge, whichever occurs first
|
|
Serum Phosphate Level
Délai: 14 days of life
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Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
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14 days of life
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feeding Tolerance
Délai: 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.
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Up to 28 days of life or hospital discharge
|
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Weight Gain Monitoring
Délai: Daily through 28 days of life or discharge
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Serial assessment of infant weight to evaluate adequacy of growth during the study period.
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Daily through 28 days of life or discharge
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Feeding Preparation Cost
Délai: Up to 28 days of life or discharge
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Cost associated with preparation of feedings, including staff time and materials required for each feeding strategy.
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Up to 28 days of life or discharge
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Total Feeding Cost
Délai: First 28 days of life or until discharge
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Total cost of feeding over the study period, including milk, fortifier, formula, and preparation time.
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First 28 days of life or until discharge
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Length of Stay
Délai: From birth to hospital discharge (up to 10 weeks)
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Duration of hospitalization in the NICU.
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From birth to hospital discharge (up to 10 weeks)
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Total NICU cost of care
Délai: From birth to hospital discharge (up to 10 weeks)
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Total hospital costs incurred during NICU stay, including all resources utilized.
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From birth to hospital discharge (up to 10 weeks)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sarah Taylor, MD, Yale University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MMIB-NEOMOM-2000042290
- R44HD110306 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime 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.
Délai de partage IPD
Critères d'accès au 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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