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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Elizabeth Nelson, PhD
- Numer telefonu: 2679818066
- E-mail: enelson@mmib.health
Lokalizacje studiów
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Connecticut
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New Haven, Connecticut, Stany Zjednoczone, 06511
- Yale University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Growth Velocity
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Feeding Tolerance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Sarah Taylor, MD, Yale University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- MMIB-NEOMOM-2000042290
- R44HD110306 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
Typ informacji pomocniczych dotyczących udostępniania IPD
- CSR
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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Badania kliniczne na Human Milk Concentration Device
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