Canadian Oxygen Trial (COT)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | December 2006 |
| End Date: | December 2012 |
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 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?
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?
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.
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.
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
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4
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Pennsylvania Hospital Pennsylvania Hospital, the nation's first hospital, has been a leader in patient care,...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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