Canadian Oxygen Trial (COT)

Respiratory Insufficiency of Prematurity Clinical Trial

— COT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637169
• Other study ID #: NTG-2006-COT
• Secondary ID: MCT-79217/ISRCTN
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2008
• Last updated: March 20, 2018
• Start date: December 2006
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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 information / eligibility

• Status: Completed
• Enrollment: 1201
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Insufficiency of Prematurity

Intervention

Other:
• Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.

Locations

Country	Name	City	State
Argentina	Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network	Buenos Aires
Canada	Foothills Hospital	Calgary	Alberta
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	IWK Health Centre	Halifax	Nova Scotia
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	CHU Ste. Justine	Montreal	Quebec
Canada	Royal Victoria Hospital	Montreal	Quebec
Canada	Children's Hospital of Eastern Ontario and Ottawa General Hospital	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	B.C. Children's Hospital	Vancouver	British Columbia
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Canada	Winnipeg Health Sciences Centre	Winnipeg	Manitoba
Finland	Oulu University Central Hospital	Oulu
Germany	University Children's Hospital	Tuebingen
Israel	Soroka University Medical Center	Beer Sheva
Israel	Bnai-Zion Medical Center	Haifa
Israel	Meir Medical Center	Kfar-Saba
United States	Hospital of the University of Pennsylvania (HUP)	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania
United States	Stony Brook University Medical Center	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Countries where clinical trial is conducted

United States,  Argentina,  Canada,  Finland,  Germany,  Israel, 

References & Publications (2)

Schmidt B, Roberts RS, Whyte RK, Asztalos EV, Poets C, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Group. Impact of study oximeter masking algorithm on titration of oxygen therapy in the Canadian oxygen trial. J Pediatr. 2014 Oct;165(4):666-71.e2. — View Citation

Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, Solimano A, Roberts RS; Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)		18-21 months corrected for prematurity
Secondary	Retinopathy of prematurity		32 to 44 weeks postmenstrual age
Secondary	Bronchopulmonary dysplasia		36 weeks postmenstrual age
Secondary	Brain injury		from week one of life up to 36 weeks postmenstrual age
Secondary	Patent ductus arteriosus		until first discharge home
Secondary	Necrotizing enterocolitis		until first discharge home
Secondary	Growth		until 18-21 months corrected for prematurity
Secondary	respiratory morbidity		until 18-21 months corrected for prematurity
Secondary	Mean developmental index scores on the Bayley Scales		18-21 months corrected for prematurity