Canadian Oxygen Trial (COT) (COT)

March 20, 2018 updated by: 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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1201

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • Germany
      • Tuebingen, Germany
        • University Children's Hospital
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Haifa, Israel, 31048
        • Bnai-Zion Medical Center
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
  • United States
    • New York
      • Stony Brook, New York, United States, 11794-8111
        • Stony Brook University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania (HUP)
      • Philadelphia, Pennsylvania, United States, 19035
        • Pennsylvania Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Other Names:
  • Masimo Radical Pulse Oximeter
Active Comparator: 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.
Other: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Other Names:
  • Masimo Radical Pulse Oximeter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
Time Frame: 18-21 months corrected for prematurity
18-21 months corrected for prematurity

Secondary Outcome Measures

Outcome Measure
Time Frame
Retinopathy of prematurity
Time Frame: 32 to 44 weeks postmenstrual age
32 to 44 weeks postmenstrual age
Bronchopulmonary dysplasia
Time Frame: 36 weeks postmenstrual age
36 weeks postmenstrual age
Brain injury
Time Frame: 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
Time Frame: until first discharge home
until first discharge home
Necrotizing enterocolitis
Time Frame: until first discharge home
until first discharge home
Growth
Time Frame: until 18-21 months corrected for prematurity
until 18-21 months corrected for prematurity
respiratory morbidity
Time Frame: until 18-21 months corrected for prematurity
until 18-21 months corrected for prematurity
Mean developmental index scores on the Bayley Scales
Time Frame: 18-21 months corrected for prematurity
18-21 months corrected for prematurity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 6, 2008

First Submitted That Met QC Criteria

March 10, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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