Canadian Oxygen Trial (COT)
- Conditions
- Respiratory Insufficiency of Prematurity
- Registration Number
- NCT00637169
- Lead Sponsor
- 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?
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1201
- Gestational age 23 0/7 - 27 6/7 weeks
- Postnatal age < 24 hours
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) 18-21 months corrected for prematurity
- Secondary Outcome Measures
Name Time Method Growth until 18-21 months corrected for prematurity respiratory morbidity until 18-21 months corrected for prematurity Retinopathy of prematurity 32 to 44 weeks postmenstrual age Bronchopulmonary dysplasia 36 weeks postmenstrual age Brain injury from week one of life up to 36 weeks postmenstrual age Patent ductus arteriosus until first discharge home Necrotizing enterocolitis until first discharge home Mean developmental index scores on the Bayley Scales 18-21 months corrected for prematurity
Trial Locations
- Locations (23)
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania (HUP)
🇺🇸Philadelphia, Pennsylvania, United States
Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network
🇦🇷Buenos Aires, Argentina
Foothills Hospital
🇨🇦Calgary, Alberta, Canada
Royal Alexandra Hospital
🇨🇦Edmonton, Alberta, Canada
B.C. Children's Hospital
🇨🇦Vancouver, British Columbia, Canada
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Winnipeg Health Sciences Centre
🇨🇦Winnipeg, Manitoba, Canada
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Scroll for more (13 remaining)Stony Brook University Medical Center🇺🇸Stony Brook, New York, United States