Canadian Oxygen Trial (COT) - Full Text View

Sponsors and Collaborators:	McMaster University Canadian Institutes of Health Research (CIHR)
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00637169

Purpose

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?

Condition	Intervention	Phase
Respiratory Insufficiency of Prematurity	Other: Titration of oxygen therapy	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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)

Further study details as provided by McMaster University:

Primary Outcome Measures:

Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) [ Time Frame: 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Retinopathy of prematurity [ Time Frame: 32 to 44 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
Bronchopulmonary dysplasia [ Time Frame: 36 weeks postmenstrual age ] [ Designated as safety issue: No ]
Brain injury [ Time Frame: from week one of life up to 36 weeks postmenstrual age ] [ Designated as safety issue: Yes ]
Patent ductus arteriosus [ Time Frame: until first discharge home ] [ Designated as safety issue: Yes ]
Necrotizing enterocolitis [ Time Frame: until first discharge home ] [ Designated as safety issue: Yes ]
Growth [ Time Frame: until 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]
respiratory morbidity [ Time Frame: until 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]
Mean developmental index scores on the Bayley Scales [ Time Frame: 18-21 months corrected for prematurity ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1200
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.	Other: Titration of oxygen therapy Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
2: Active Comparator 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.	Other: Titration of oxygen therapy Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.

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.

Eligibility

Ages Eligible for Study:	up to 24 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637169

Contacts

Contact: Lorrie Costantini

905-527-2299 ext 43783

costan@mcmaster.ca

Locations

United States, New York
Stony Brook University Medical Center	Recruiting
Stony Brook, New York, United States, 11794-8111
Contact: Shanthy Sridhar, MD 631-444-7653 shanthy.sridhar@stonybrook.edu
Principal Investigator: Shanthy Sridhar, MD
United States, Pennsylvania
Pennsylvania Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19035
Contact: Soraya Abbasi, MD 215-829-3301 soraya.abbasi@uphs.upenn.edu
Principal Investigator: Soraya Abbasi, MD
Hospital of the University of Pennsylvania (HUP)	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu
Principal Investigator: Barbara Schmidt, MD
Argentina
Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network	Recruiting
Buenos Aires, Argentina
Contact: Nestor Vain, MD 54 11 4127 5534 nvain@trinidad.com.ar
Principal Investigator: Nestor Vain, MD
Canada, Alberta
Royal Alexandra Hospital	Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Abraham Peliowski, MC 780-735-4670 apeliows@cha.ab.ca
Principal Investigator: Abraham Peliowski, MD
Principal Investigator: Manoj Kumar, MD
Foothills Hospital	Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Jack Rabi, MD 403-944-1615 jack.rabi@calgaryhealthregion.ca
Principal Investigator: Jack Rabi, MD
Principal Investigator: Reginald Sauve, MD
Canada, British Columbia
B.C. Children's Hospital	Recruiting
Vancouver, British Columbia, Canada, V6H 3V4
Contact: Alfonso Solimano, MD 604-875-2135 asolimano@cw.bc.ca
Principal Investigator: Alfonso Solimano, MD
Canada, Manitoba
St. Boniface General Hospital	Recruiting
Winnipeg, Manitoba, Canada, R3E 0L8
Contact: Aaron Chiu, MD 204-787-1829 chiua@cc.umanitoba.ca
Principal Investigator: Aaron Chiu, MD
Principal Investigator: Diane Moddemann, MD
Winnipeg Health Sciences Centre	Recruiting
Winnipeg, Manitoba, Canada, R3L 0L8
Contact: Molly Seshia, MD 204-787-1853 mseshia@cc.umanitoba.ca
Principal Investigator: Molly Seshia, MD
Canada, Nova Scotia
IWK Health Centre	Recruiting
Halifax, Nova Scotia, Canada, B3P 1R8
Contact: Robin Whyte, MD 902-470-7426 robin.whyte@dal.ca
Principal Investigator: Robin Whyte, MD
Canada, Ontario
Sunnybrook Health Sciences Centre	Recruiting
Toronto, Ontario, Canada, M5S 1B2
Contact: Elizabeth Asztalos, MD 416-323-6266 elizabeth.asztalos@sunnybrook.ca
Principal Investigator: Elizabeth Asztalos, MD
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Prakeshkumar Shah, MD 416-586-4761 pshah@mtsinai.on.ca
Principal Investigator: Prakeshkumar Shah, MD
Kingston General Hospital	Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Maxine Clarke, MD 613-548-6144 clarkem@kgh.kari.net
Principal Investigator: Maxine Clarke, MD
Children's Hospital of Eastern Ontario and Ottawa General Hospital	Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Contact: JoAnn Harrold, MD 613-737-7600 ext 2417 jharrold@cheo.on.ca
Principal Investigator: JoAnn Harrold, MD
McMaster University Medical Centre	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Madan Roy, MD 905-521-2100 ext 75639 roym@mcmaster.ca
Principal Investigator: Madan Roy, MD
Canada, Quebec
Centre Hospitalier Universitaire de Quebec	Recruiting
Quebec City, Quebec, Canada, G1L 3L5
Contact: Aida Bairam, MD 418-525-4402 aida.bairam@crsfa.ulaval.ca
Principal Investigator: Aida Bairam, MD
Sub-Investigator: Marianne Deschenes, MD
Royal Victoria Hospital	Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: Nabeel Ali, MD 514-934-1934 ext 34876 nabeel.ali@mcgill.ca
Principal Investigator: Nabeel Ali, MD
CHU Ste. Justine	Not yet recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Keith Barrington, MD 514-345-4931 ext 5929 keith.barrington@mcgill.ca
Principal Investigator: Keith Barrington, MD
Canada, Saskatchewan
Royal University Hospital	Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact: Laurentiu Givelichian, MD 306-966-8118 dr.givelichian@usask.ca
Principal Investigator: Laurentiu Givelichian, MD
Sub-Investigator: Koravangattu Sankaran, MD
Finland
Oulu University Central Hospital	Recruiting
Oulu, Finland
Contact: M. Hallman, MD 358 8 315 5101 mikko.hallman@oulu.fi
Principal Investigator: M. Hallman, MD
Germany
University Children's Hospital	Recruiting
Tuebingen, Germany
Contact: Dirk Bassler, MD 011 49 7071 2984715 dirk.bassler@med.uni-tuebingen.de
Principal Investigator: Christian Poets, MD
Principal Investigator: Dirk Bassler, MD
Israel
Meir Medical Center	Recruiting
Kfar-Saba, Israel, 44281
Contact: Shmuel Arnon, MD 09-7472225 shmuelar@clalit.org.il
Principal Investigator: Shmuel Arnon, MD
Bnai-Zion Medical Center	Recruiting
Haifa, Israel, 31048
Contact: David Bader, MD 972 4 8359359 alona500@netvision.net.il
Principal Investigator: David Bader, MD

Sponsors and Collaborators

McMaster University

Canadian Institutes of Health Research (CIHR)

Investigators

Study Chair:	Barbara Schmidt, MD	McMaster University
Principal Investigator:	Robin Roberts, MMath	Hamilton Health Sciences/McMaster University
Principal Investigator:	Elizabeth Asztalos, MD	Sunnybrook Health Sciences Centre
Principal Investigator:	Alfonso Solimano, MD	Children's & Women's Health Centre of BC
Principal Investigator:	Keith Barrington, MD	Royal Victoria Hospital
Principal Investigator:	Robin Whyte, MD	IWK Health Centre

More Information

No publications provided

Responsible Party:	McMaster University ( Barbara Schmidt/Nominated PI )
Study ID Numbers:	NTG-2006-COT, MCT-79217/ISRCTN62491227
Study First Received:	March 6, 2008
Last Updated:	January 27, 2009
ClinicalTrials.gov Identifier:	NCT00637169 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by McMaster University:

oxygen therapy
neurodevelopmental impairment

Study placed in the following topic categories:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders
Benzocaine
Stress

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on May 07, 2009