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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 10.1186/ISRCTN62491227
ClinicalTrials.gov identifier NCT00637169
EudraCT number
Public 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
Scientific title
Acronym COT
Serial number at source MCT-79217
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?
Lay summary Not provided at time of registration
Ethics approval Research Ethics Board, McMaster University (Hamilton Health Sciences) approved on August 10, 2006; REBs for other four countries are pending.
Study design Two arm randomised parallel controlled trial with study participant, investigator, caregiver, outcome assessor, and data analyst blinded.
Countries of recruitment Argentina, Canada, Finland, Germany, Norway
Disease/condition/study domain Respiratory insufficiency of prematurity
Participants - inclusion criteria 1. Gestational age 23^0/7 to 27^6/7 weeks
2. Postnatal age less than 24 hours, either sex
Participants - 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
Anticipated start date 01/10/2006
Anticipated end date 28/02/2011
Status of trial Completed
Patient information material
Target number of participants 1200
Interventions 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.
Primary outcome measure(s) 1. Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)
Secondary outcome measure(s) 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
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79217)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23644995
Contact name Dr  Barbara Kristina  Schmidt
  Address McMaster University
1200 Main Street West
Room 3N11E
Hamilton
  City/town Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 905 521 2100 (73243)
  Fax +1 905 521 7914
  Email schmidt@mcmaster.ca
Sponsor McMaster University (Canada)
  Address 1200 Main Street West
Hamilton
  City/town Ontario
  Zip/Postcode L8N 3Z5
  Country Canada
  Tel +1 (905) 525-9140
  Fax +1 (905) 570-0742 (RESEARCH)
  Email hsresadm@mcmaster.ca
Date applied 22/08/2006
Last edited 08/05/2013
Date ISRCTN assigned 22/08/2006
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