Efficacy and safety of targeting lower arterial oxygen saturations to reduce oxygen toxicity and oxidative stress in very preterm infants: the Canadian Oxygen Trial

ISRCTN	ISRCTN62491227
DOI	https://doi.org/10.1186/ISRCTN62491227
ClinicalTrials.gov number	NCT00637169
Secondary identifying numbers	MCT-79217

Submission date: 22/08/2006
Registration date: 22/08/2006
Last edited: 08/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Barbara Kristina Schmidt
Scientific

McMaster University
1200 Main Street West
Room 3N11E
Hamilton
Ontario
L8N 3Z5
Canada

Phone	+1 905 521 2100 (73243)
Email	schmidt@mcmaster.ca

Study information

Study design	Two arm randomised parallel controlled trial with study participant, investigator, caregiver, outcome assessor, and data analyst blinded.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	COT
Study hypothesis	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?
Ethics approval(s)	Research Ethics Board, McMaster University (Hamilton Health Sciences) approved on August 10, 2006; REBs for other four countries are pending.
Condition	Respiratory insufficiency of prematurity
Intervention	Exerimental arm: supplemental oxygen to maintain functional arterial oxygen saturations in the range of 85-89%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations. Duration: Until first discharge to home. Control arm: Supplemental oxygen to maintain functional arterial oxygen saturations in the range of 91-95%. Dose of oxygen is determined by the individual infant's need to achieve the target oxygen saturations. Duration: Until first discharge to home.
Intervention type	Other
Primary outcome measure	1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
Secondary outcome measures	1. Retinopathy of prematurity measured at 32 to 44 weeks postmenstrual age 2. Bronchopulmonary dysplasia measured at 36 weeks postmenstrual age 3. Brain injury, measured from the week one of life up to 36 weeks postmenstrual age 4. Patent ductus arteriosus, measured until first discharge to home 5. Necrotising enterocolitis measured until first discharge to home 6. Growth, measured until a corrected age of 18 to 21 months 7. Respiratory morbidity, measured until a corrected age of 18 to 21 months 8. Mean developmental index scores on the Bayley Scales measured at the corrected age of 18 to 21 months
Overall study start date	01/10/2006
Overall study end date	28/02/2011

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	1200
Participant inclusion criteria	1. Gestational age 23^0/7 to 27^6/7 weeks 2. Postnatal age less than 24 hours, either sex
Participant exclusion criteria	1. Infant not considered viable 2. Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment 3. Known or strongly suspected cyanotic heart disease 4. Persistent pulmonary hypertension 5. Unlikely to be available for long-term follow-up
Recruitment start date	01/10/2006
Recruitment end date	28/02/2011

Locations

Countries of recruitment

Argentina
Canada
Finland
Germany
Norway

Study participating centre

McMaster University

Ontario
L8N 3Z5
Canada

Sponsor information

McMaster University (Canada)
University/education

1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada

Phone	+1 (905) 525-9140
Email	hsresadm@mcmaster.ca
"ROR"	https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79217)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/05/2013		Yes	No