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

4. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

310

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Connecticut
      • New Haven, Connecticut, Vereinigte Staaten, 06511
        • Yale University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Aktiver 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Growth Velocity
Zeitfenster: 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
Zeitfenster: 14 days of life
Serum phosphate concentration as a marker of mineral status in preterm infants receiving assigned feeding strategy.
14 days of life

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feeding Tolerance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mother's Milk is Best

Mitarbeiter

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

Ermittler

  • Hauptermittler: Sarah Taylor, MD, Yale University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

14. März 2027

Studienabschluss (Geschätzt)

1. Juli 2028

Studienanmeldedaten

Zuerst eingereicht

29. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. Mai 2026

Zuerst gepostet (Tatsächlich)

8. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MMIB-NEOMOM-2000042290
  • R44HD110306 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

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

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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