Canadian Oxygen Trial (COT)
This study has been completed.
Sponsor:
McMaster University
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
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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
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 June 18, 2013