Canadian Oxygen Trial (COT)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Barbara Schmidt, McMaster University
ClinicalTrials.gov Identifier:
NCT00637169
First received: March 6, 2008
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Respiratory Insufficiency of Prematurity
Other: Titration of oxygen therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) [ Time Frame: 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Retinopathy of prematurity [ Time Frame: 32 to 44 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
  • Bronchopulmonary dysplasia [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
  • Brain injury [ Time Frame: from week one of life up to 36 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
  • Patent ductus arteriosus [ Time Frame: until first discharge home ] [ Designated as safety issue: Yes ]
  • Necrotizing enterocolitis [ Time Frame: until first discharge home ] [ Designated as safety issue: Yes ]
  • Growth [ Time Frame: until 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]
  • respiratory morbidity [ Time Frame: until 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]
  • Mean developmental index scores on the Bayley Scales [ Time Frame: 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]

Enrollment: 1201
Study Start Date: December 2006
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637169

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

Publications:
Responsible Party: Barbara Schmidt, Nominated PI, McMaster University
ClinicalTrials.gov Identifier: NCT00637169     History of Changes
Other Study ID Numbers: NTG-2006-COT, MCT-79217/ISRCTN62491227
Study First Received: March 6, 2008
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
oxygen therapy
neurodevelopmental impairment

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014