Condition category
Pregnancy and Childbirth
Date applied
22/08/2006
Date assigned
22/08/2006
Last edited
08/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

Additional files

Editorial Notes