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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Elizabeth Nelson, PhD
- Numero di telefono: 2679818066
- Email: enelson@mmib.health
Luoghi di studio
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Connecticut
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New Haven, Connecticut, Stati Uniti, 06511
- Yale University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Growth Velocity
Lasso di tempo: 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
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Serum Phosphate Level
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feeding Tolerance
Lasso di tempo: Up to 28 days of life or hospital discharge
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Sarah Taylor, MD, Yale University
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MMIB-NEOMOM-2000042290
- R44HD110306 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
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