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Sponsors and Collaborators: |
McMaster University Canadian Institutes of Health Research (CIHR) |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00637169 |
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 |
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) |
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.
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Other: Titration of oxygen therapy
Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges.
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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.
|
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.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lorrie Costantini | 905-527-2299 ext 43783 | costan@mcmaster.ca |
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 |
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 |
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 |
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