Canadian Oxygen Trial (COT)

Last updated: March 20, 2018
Sponsor: McMaster University
Overall Status: Completed

Phase

3

Condition

Lung Injury

Respiratory Failure

Treatment

N/A

Clinical Study ID

NCT00637169
NTG-2006-COT
MCT-79217/ISRCTN62491227
  • Ages < 24
  • All Genders

Study Summary

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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestational age 23 0/7 - 27 6/7 weeks

  • Postnatal age < 24 hours

Exclusion

Exclusion Criteria:

  • Infant not considered viable (decision made not to administer effective therapies)

  • Dysmorphic features or congenital malformations that adversely affect life expectancyor 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

Study Design

Total Participants: 1201
Study Start date:
December 01, 2006
Estimated Completion Date:
December 31, 2012

Study Description

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.

Connect with a study center

  • Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network

    Buenos Aires,
    Argentina

    Site Not Available

  • Foothills Hospital

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • B.C. Children's Hospital

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • St. Boniface General Hospital

    Winnipeg, Manitoba R3E 0L8
    Canada

    Site Not Available

  • Winnipeg Health Sciences Centre

    Winnipeg, Manitoba R3L 0L8
    Canada

    Site Not Available

  • IWK Health Centre

    Halifax, Nova Scotia B3P 1R8
    Canada

    Site Not Available

  • McMaster University Medical Centre

    Hamilton, Ontario L8N 3Z5
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario and Ottawa General Hospital

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Mount Sinai Hospital

    Toronto, Ontario M5G 1X5
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M5S 1B2
    Canada

    Site Not Available

  • CHU Ste. Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • Royal Victoria Hospital

    Montreal, Quebec H3A 1A1
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Quebec

    Quebec City, Quebec G1L 3L5
    Canada

    Site Not Available

  • Royal University Hospital

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Oulu University Central Hospital

    Oulu,
    Finland

    Site Not Available

  • University Children's Hospital

    Tuebingen,
    Germany

    Site Not Available

  • Soroka University Medical Center

    Beer Sheva, 84101
    Israel

    Site Not Available

  • Bnai-Zion Medical Center

    Haifa, 31048
    Israel

    Site Not Available

  • Meir Medical Center

    Kfar-Saba, 44281
    Israel

    Site Not Available

  • Stony Brook University Medical Center

    Stony Brook, New York 11794-8111
    United States

    Site Not Available

  • Hospital of the University of Pennsylvania (HUP)

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Pennsylvania Hospital

    Philadelphia, Pennsylvania 19035
    United States

    Site Not Available

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