|
ISRCTN
|
ISRCTN62491227
|
|
ClinicalTrials.gov identifier
|
NCT00637169
|
|
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?
|
|
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
|
Canada, Germany, Finland, Norway, and Argentina
|
|
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
|
Ongoing
|
|
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
|
|
|
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
|
01/12/2008
|
|
Date ISRCTN assigned
|
22/08/2006
|
