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Canadian Oxygen Trial (COT) (COT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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?

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency of Prematurity Other: Titration of oxygen therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : December 2006
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

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 Name: 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 Name: Masimo Radical Pulse Oximeter




Primary Outcome Measures :
  1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) [ Time Frame: 18-21 months corrected for prematurity ]

Secondary Outcome Measures :
  1. Retinopathy of prematurity [ Time Frame: 32 to 44 weeks postmenstrual age ]
  2. Bronchopulmonary dysplasia [ Time Frame: 36 weeks postmenstrual age ]
  3. Brain injury [ Time Frame: from week one of life up to 36 weeks postmenstrual age ]
  4. Patent ductus arteriosus [ Time Frame: until first discharge home ]
  5. Necrotizing enterocolitis [ Time Frame: until first discharge home ]
  6. Growth [ Time Frame: until 18-21 months corrected for prematurity ]
  7. respiratory morbidity [ Time Frame: until 18-21 months corrected for prematurity ]
  8. Mean developmental index scores on the Bayley Scales [ Time Frame: 18-21 months corrected for prematurity ]


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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637169


Locations
Show Show 23 study locations
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
Investigators
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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 of Results:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00637169    
Other Study ID Numbers: NTG-2006-COT
MCT-79217/ISRCTN62491227
First Posted: March 17, 2008    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: December 2014
Keywords provided by McMaster University:
oxygen therapy
neurodevelopmental impairment
Additional relevant MeSH terms:
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Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases