Canadian Oxygen Trial (COT)

Completed · Phase 3

Conditions studied: Respiratory Insufficiency of Prematurity

In brief

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?

Key facts

Study ID

NCT00637169

Run by

McMaster University

People needed

1201

Starts

2006-12-01

Expected to finish

2012-12-01

Last updated by the study team

2018-03-22

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Gestational age 23 0/7 - 27 6/7 weeks
• Postnatal age < 24 hours

You may not qualify if…

• 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

Where it is running

• 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
• McMaster University Medical Centre — Hamilton, Ontario, Canada
• Children's Hospital of Eastern Ontario and Ottawa General Hospital — Ottawa, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Royal Victoria Hospital — Montreal, Quebec, Canada
• CHU Ste. Justine — Montreal, Quebec, Canada
• Centre Hospitalier Universitaire de Quebec — Québec, Quebec, Canada
• Royal University Hospital — Saskatoon, Saskatchewan, Canada
• Oulu University Central Hospital — Oulu, Finland
• University Children's Hospital — Tübingen, Germany
• Soroka University Medical Center — Beersheba, Israel
• Bnai-Zion Medical Center — Haifa, Israel
• Meir Medical Center — Kfar Saba, Israel

Full record on ClinicalTrials.gov

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