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Canadian Oxygen Trial (COT) (COT)

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ClinicalTrials.gov Identifier: NCT00637169
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE March 6, 2008
First Posted Date  ICMJE March 17, 2008
Last Update Posted Date March 22, 2018
Study Start Date  ICMJE December 2006
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) [ Time Frame: 18-21 months corrected for prematurity ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
  • Retinopathy of prematurity [ Time Frame: 32 to 44 weeks postmenstrual age ]
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks postmenstrual age ]
  • Brain injury [ Time Frame: from week one of life up to 36 weeks postmenstrual age ]
  • Patent ductus arteriosus [ Time Frame: until first discharge home ]
  • Necrotizing enterocolitis [ Time Frame: until first discharge home ]
  • Growth [ Time Frame: until 18-21 months corrected for prematurity ]
  • respiratory morbidity [ Time Frame: until 18-21 months corrected for prematurity ]
  • Mean developmental index scores on the Bayley Scales [ Time Frame: 18-21 months corrected for prematurity ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Canadian Oxygen Trial (COT)
Official Title  ICMJE 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)
Brief 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?
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Insufficiency of Prematurity
Intervention  ICMJE Other: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
Other Name: Masimo Radical Pulse Oximeter
Study Arms  ICMJE
  • 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.
    Intervention: Other: Titration of oxygen therapy
  • 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.
    Intervention: Other: Titration of oxygen therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2013)
1201
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2008)
1200
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Canada,   Finland,   Germany,   Israel,   United States
Removed Location Countries Norway
 
Administrative Information
NCT Number  ICMJE NCT00637169
Other Study ID Numbers  ICMJE NTG-2006-COT
MCT-79217/ISRCTN62491227
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
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
PRS Account McMaster University
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP