Contact information
Type
Scientific
Primary contact
Dr Barbara Kristina Schmidt
ORCID ID
Contact details
McMaster University
1200 Main Street West
Room 3N11E
Hamilton
Ontario
L8N 3Z5
Canada
+1 905 521 2100 (73243)
schmidt@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00637169
Protocol/serial number
MCT-79217
Study information
Scientific title
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
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/10/2006
Overall trial end date
28/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Gestational age 23^0/7 to 27^6/7 weeks
2. Postnatal age less than 24 hours, either sex
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
1200
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
Trial participating centre
McMaster University
Ontario
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
+1 (905) 525-9140
hsresadm@mcmaster.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79217)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23644995
Publication citations
-
Results
Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, Solimano A, Roberts RS, , Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial., JAMA, 2013, 309, 20, 2111-2120, doi: 10.1001/jama.2013.5555.