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Canadian Oxygen Trial (COT) (COT)

Primary Purpose

Respiratory Insufficiency of Prematurity

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Titration of oxygen therapy

About this trial

This is an interventional treatment trial for Respiratory Insufficiency of Prematurity focused on measuring oxygen therapy, neurodevelopmental impairment

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Gestational age 23 0/7 - 27 6/7 weeks
Postnatal age < 24 hours

Exclusion Criteria:

Infant not considered viable (decision made not to administer effective therapies)
Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment
Known or strongly suspected cyanotic heart disease
Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia
Unlikely to be available for long-term follow-up

Sites / Locations

Stony Brook University Medical Center
Pennsylvania Hospital
Hospital of the University of Pennsylvania (HUP)
Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network
Foothills Hospital
Royal Alexandra Hospital
B.C. Children's Hospital
St. Boniface General Hospital
Winnipeg Health Sciences Centre
IWK Health Centre
McMaster University Medical Centre
Children's Hospital of Eastern Ontario and Ottawa General Hospital
Mount Sinai Hospital
Sunnybrook Health Sciences Centre
Royal Victoria Hospital
CHU Ste. Justine
Centre Hospitalier Universitaire de Quebec
Royal University Hospital
Oulu University Central Hospital
University Children's Hospital
Soroka University Medical Center
Bnai-Zion Medical Center
Meir Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)

Secondary Outcome Measures

Retinopathy of prematurity

Bronchopulmonary dysplasia

Brain injury

Patent ductus arteriosus

Necrotizing enterocolitis

Growth

respiratory morbidity

Mean developmental index scores on the Bayley Scales

Full Information

NCT ID

NCT00637169

First Posted

March 6, 2008

Last Updated

March 20, 2018

Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT00637169

Brief Title

Canadian Oxygen Trial (COT)

Acronym

COT

Official 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 (COT)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McMaster University

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Study Question: 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?

Detailed Description

Most extremely preterm babies require supplemental oxygen for several weeks or even months after birth. The goal of oxygen therapy is to achieve adequate oxygen delivery to the tissues without causing oxygen toxicity and oxidative stress. At present, this goal is elusive in very immature infants. Although it is standard practice in modern neonatal intensive care units to monitor arterial oxygen saturations via pulse oximetry, there is insufficient evidence to guide the choice of the upper and lower alarm limits. A rigorous trial with long-term follow up is urgently needed and long overdue to determine whether oxygen exposure can be reduced safely in extremely preterm infants without increasing the risk of hypoxic death or disability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency of Prematurity

Keywords

oxygen therapy, neurodevelopmental impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1201 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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.

Arm Title

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Titration of oxygen therapy

Other Intervention Name(s)

Masimo Radical Pulse Oximeter

Intervention Description

Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.

Primary Outcome Measure Information:

Title

Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity)

Time Frame

18-21 months corrected for prematurity

Secondary Outcome Measure Information:

Title

Retinopathy of prematurity

Time Frame

32 to 44 weeks postmenstrual age

Title

Bronchopulmonary dysplasia

Time Frame

36 weeks postmenstrual age

Title

Brain injury

Time Frame

from week one of life up to 36 weeks postmenstrual age

Title

Patent ductus arteriosus

Time Frame

until first discharge home

Title

Necrotizing enterocolitis

Time Frame

until first discharge home

Title

Growth

Time Frame

until 18-21 months corrected for prematurity

Title

respiratory morbidity

Time Frame

until 18-21 months corrected for prematurity

Title

Mean developmental index scores on the Bayley Scales

Time Frame

18-21 months corrected for prematurity

10. Eligibility

Sex

All

Maximum Age & Unit of Time

24 Hours

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Gestational age 23 0/7 - 27 6/7 weeks Postnatal age < 24 hours Exclusion Criteria: Infant not considered viable (decision made not to administer effective therapies) Dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment Known or strongly suspected cyanotic heart disease Persistent pulmonary hypertension, e.g. associated with pulmonary hypoplasia Unlikely to be available for long-term follow-up

Overall Study Officials: