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Human Milk Concentrating Device to Optimize Mother's Own Milk (NEOMOM)

4. maj 2026 opdateret af: Mother's Milk is Best

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

310

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06511
        • Yale University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: Human Milk Concentration Device
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.
Aktiv 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.
Andet: Standard of Care Fortified Feeding
Mother's own milk supplemented with cow's milk-based human milk fortifier and/or formula according to institutional standard of care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Growth Velocity
Tidsramme: 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
Tidsramme: 14 days of life
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
14 days of life

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Feeding Tolerance
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Mother's Milk is Best

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Yale University
Beth Israel Deaconess Medical Center
Weill Medical College of Cornell University

Efterforskere

  • Ledende efterforsker: Sarah Taylor, MD, Yale University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

14. marts 2027

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

29. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

8. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MMIB-NEOMOM-2000042290
  • R44HD110306 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

Beginning 6-12 months following publication and ending 3-5 years after publication.

IPD-delingsadgangskriterier

Access to de-identified individual participant data will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study sponsor to ensure the proposed use is scientifically and ethically appropriate and consistent with participant consent and institutional policies. Data sharing will require execution of a data use agreement and may require Institutional Review Board approval or exemption, as applicable. Data will be shared in a manner that protects participant privacy and confidential information.

IPD-deling Understøttende informationstype

  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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