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How Different Levels of CPAP Affect Oxygen Delivery and Lung Expansion in Preterm Infants

23. juni 2026 opdateret af: University of Arkansas

Oxygen Delivery in CPAP and Its Relationship With Regional Lung Ventilation in Preterm Infants

With this study, it is expected to learn more about preterm babies on breathing support with nasal continuous positive airway pressure (nCPAP). To gain more information on how much oxygen is actually delivered to the baby from the nCPAP machine.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study will tell more about a specific method of breathing support used frequently with preterm babies called nasal continuous positive airway pressure (nCPAP). It helps the baby breathe by providing air pressure and a certain amount of oxygen. It is very important for the baby's health to provide only as much oxygen as they need.

With this study, it is expected to learn if the amount of oxygen ordered by a doctor on the nCPAP machine changes when it reaches the baby's airway, and if the amount of oxygen changes depending on how much air pressure the doctor provides. The answers to these questions, are not known, because special measurements are required that are difficult to know while a baby is on nCPAP. This study will collect these special measurements

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10

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
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Ikke rekrutterer endnu
        • University of Arkansas for Medical Sciences
        • Kontakt:
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Rekruttering
        • University of Arkansas for Medical Sciences
        • Kontakt:
        • Ledende efterforsker:
          • Nicholas Rowley, MD

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
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Gestational age at birth must be less than 35 weeks of completed gestation as documented in the subject's initial history and physical
  • The infant must be stable while receiving nasal CPAP at any pressure level at the time of study
  • The infant must be receiving 22-40% at the time of the study

Exclusion Criteria:

  • Oxygen requirements greater than 40% at time of enrollment
  • currently receiving invasive ventilation or not requiring ventilatory support
  • Major congenital anomalies of the heart and/or lungs

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Infants on nCPAP
All infants on CPAP will have a catheter placed in their oropharynx to measure delivered oxygen and a soft band placed around the infant's chest to measure lung expansion.
Enhed: Effective oxygen delivery and lung expansion measurement
This intervention arm will involve any infant who is already on nCPAP. It will involve placing a catheter in the infant's oropharynx and wrapping soft EIT bands around the infants chest to measure effective oxygen delivery and lung expansion, respectively.
Andre navne:
  • EIT

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inspired Oxygen
Tidsramme: Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.
Percent of oxygen delivered to the back of the infant's mouth. This will be measured by placing a small plastic tube in the back of the infant's mouth and sampling the air while the infant is receiving several different pressure levels of CPAP.
Sampling will occur at three separate points within a thirty minute time frame for each enrolled infant.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Lung Volume
Tidsramme: Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.
Using Electrical Impedance Tomography bands, the infant's lung volume will be monitored at several different CPAP pressure levels. These bands wrap around the infant's chest and measure lung volume using mild electrical currents.
Long volume will be continuously monitored throughout the 30 minute duration of the study for each enrolled infant.

Samarbejdspartnere og efterforskere

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

Sponsor

University of Arkansas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

15. april 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. juni 2027

Datoer for studieregistrering

Først indsendt

23. juni 2026

Først indsendt, der opfyldte QC-kriterier

23. juni 2026

Først opslået (Faktiske)

30. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 299138

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Coded IPD will be shared with a collaborator once data collection is complete for the purpose of statistical analysis. All shared IPD will be de-identified and individual patients will be given an identifying code. Shared information will include gestational age, date of birth, postnatal age, race/ethnicity, vital signs, prior medical history, current respiratory support, complications during pregnancy, medical problems and diagnoses that the infant receives during hospitalization, and the inspired oxygen and lung volume values gathered during the study itself.

IPD-delingstidsramme

Beginning once data collection is complete and for three months afterward to afford time for statistical analysis.

IPD-delingsadgangskriterier

Only primary investigators will be able to access de-coded IPD. One single collaborator will have access to coded IPD for the purpose of statistical analysis.

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.

Ja

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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