Status:
COMPLETED
Canadian Oxygen Trial (COT)
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Respiratory Insufficiency of Prematurity
Eligibility:
All Genders
Up to 24 years
Phase:
PHASE3
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 ...
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...
Eligibility Criteria
Inclusion
- Gestational age 23 0/7 - 27 6/7 weeks
- Postnatal age \< 24 hours
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1201 Patients enrolled
Trial Details
Trial ID
NCT00637169
Start Date
December 1 2006
End Date
December 1 2012
Last Update
March 22 2018
Active Locations (23)
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1
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794-8111
2
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19035
3
Hospital of the University of Pennsylvania (HUP)
Philadelphia, Pennsylvania, United States, 19104
4
Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network
Buenos Aires, Argentina