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Canadian Oxygen Trial (COT) (COT)

20. marts 2018 opdateret af: McMaster University

Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants: The Canadian Oxygen Trial (COT)

Study Question: In infants who are born at gestational ages of 23 0/7 to 27 6/7 weeks, does lowering the concentration of supplemental oxygen to target an arterial oxygen saturation by pulse oximetry (SpO2)of 85-89% compared with 91-95%, from the day of birth until the baby's first discharge home, increase the probability of survival without severe neurosensory disability to a corrected age of 18 months?

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1201

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Buenos Aires, Argentina
        • Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Foothills Hospital
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • B.C. Children's Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0L8
        • St. Boniface General Hospital
      • Winnipeg, Manitoba, Canada, R3L 0L8
        • Winnipeg Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3P 1R8
        • IWK Health Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario and Ottawa General Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5S 1B2
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Ste. Justine
      • Quebec City, Quebec, Canada, G1L 3L5
        • Centre Hospitalier Universitaire de Quebec
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Finland
      • Oulu, Finland
        • Oulu University Central Hospital
  • Forenede Stater
    • New York
      • Stony Brook, New York, Forenede Stater, 11794-8111
        • Stony Brook University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania (HUP)
      • Philadelphia, Pennsylvania, Forenede Stater, 19035
        • Pennsylvania Hospital
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31048
        • Bnai-Zion Medical Center
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
  • Tyskland
      • Tuebingen, Tyskland
        • University Children's Hospital

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

Ikke ældre end 1 dag (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Gestational age 23 0/7 - 27 6/7 weeks
  • Postnatal age < 24 hours

Exclusion Criteria:

  • Infant not considered viable (decision made not to administer effective therapies)
  • Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
  • Known or strongly suspected cyanotic heart disease
  • Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
  • Unlikely to be available for long-term follow-up

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
Andet: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Andre navne:
  • Masimo Radical Pulse Oximeter
Aktiv komparator: 2
Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 91-95%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations.
Andet: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Andre navne:
  • Masimo Radical Pulse Oximeter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
Tidsramme: 18-21 months corrected for prematurity
18-21 months corrected for prematurity

Sekundære resultatmål

Resultatmål
Tidsramme
Retinopathy of prematurity
Tidsramme: 32 to 44 weeks postmenstrual age
32 to 44 weeks postmenstrual age
Bronchopulmonary dysplasia
Tidsramme: 36 weeks postmenstrual age
36 weeks postmenstrual age
Brain injury
Tidsramme: from week one of life up to 36 weeks postmenstrual age
from week one of life up to 36 weeks postmenstrual age
Patent ductus arteriosus
Tidsramme: until first discharge home
until first discharge home
Necrotizing enterocolitis
Tidsramme: until first discharge home
until first discharge home
Growth
Tidsramme: until 18-21 months corrected for prematurity
until 18-21 months corrected for prematurity
respiratory morbidity
Tidsramme: until 18-21 months corrected for prematurity
until 18-21 months corrected for prematurity
Mean developmental index scores on the Bayley Scales
Tidsramme: 18-21 months corrected for prematurity
18-21 months corrected for prematurity

Samarbejdspartnere og efterforskere

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

Sponsor

McMaster University

Samarbejdspartnere

Canadian Institutes of Health Research (CIHR)

Efterforskere

  • Studiestol: Barbara Schmidt, MD, McMaster University
  • Ledende efterforsker: Robin Roberts, MMath, Hamilton Health Sciences/McMaster University
  • Ledende efterforsker: Elizabeth Asztalos, MD, Sunnybrook Health Sciences Centre
  • Ledende efterforsker: Alfonso Solimano, MD, Children's & Women's Health Centre of BC
  • Ledende efterforsker: Robin Whyte, MD, IWK Health Centre
  • Ledende efterforsker: Jack Rabi, MD, Foothills Hospital
  • Ledende efterforsker: Christian Poets, MD, University Children's Hospital Tuebingen

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

1. december 2006

Primær færdiggørelse (Faktiske)

1. september 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

6. marts 2008

Først indsendt, der opfyldte QC-kriterier

10. marts 2008

Først opslået (Skøn)

17. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. marts 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. marts 2018

Sidst verificeret

1. december 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NTG-2006-COT
  • MCT-79217/ISRCTN62491227

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 .

Kliniske forsøg med Respiratorisk insufficiens af præmaturitet

Kliniske forsøg med Titration of oxygen therapy

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lebanon

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner