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| ID | Type | Description | Link |
|---|---|---|---|
| MCT-79217/ISRCTN62491227 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Titration of oxygen therapy | Other | Supplemental oxygen to maintain functional arterial oxygen saturations in one of two saturation target ranges. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survival without severe neurosensory disability to 18 to 21 months (corrected for prematurity) | 18-21 months corrected for prematurity |
| Measure | Description | Time Frame |
|---|---|---|
| Retinopathy of prematurity | 32 to 44 weeks postmenstrual age | |
| Bronchopulmonary dysplasia | 36 weeks postmenstrual age | |
| Brain injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Schmidt, MD | McMaster University | Study Chair |
| 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 |
| Robin Whyte, MD | IWK Health Centre | Principal Investigator |
| Jack Rabi, MD | Foothills Hospital | Principal Investigator |
| Christian Poets, MD | University Children's Hospital Tuebingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Medical Center | Stony Brook | New York | 11794-8111 | United States | ||
| Pennsylvania Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23644995 | Result | Schmidt B, Whyte RK, Asztalos EV, Moddemann D, Poets C, Rabi Y, Solimano A, Roberts RS; Canadian Oxygen Trial (COT) Group. Effects of targeting higher vs lower arterial oxygen saturations on death or disability in extremely preterm infants: a randomized clinical trial. JAMA. 2013 May 22;309(20):2111-20. doi: 10.1001/jama.2013.5555. | |
| 24973289 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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|
| from week one of life up to 36 weeks postmenstrual age |
| Patent ductus arteriosus | until first discharge home |
| Necrotizing enterocolitis | until first discharge home |
| Growth | until 18-21 months corrected for prematurity |
| respiratory morbidity | until 18-21 months corrected for prematurity |
| Mean developmental index scores on the Bayley Scales | 18-21 months corrected for prematurity |
| Philadelphia |
| Pennsylvania |
| 19035 |
| United States |
| Hospital of the University of Pennsylvania (HUP) | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital Sanatorio de la Trinidad & Buenos Aires NICU Network | Buenos Aires | Argentina |
| Foothills Hospital | Calgary | Alberta | T2N 2T9 | Canada |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3V9 | Canada |
| B.C. Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R3E 0L8 | Canada |
| Winnipeg Health Sciences Centre | Winnipeg | Manitoba | R3L 0L8 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3P 1R8 | Canada |
| McMaster University Medical Centre | Hamilton | Ontario | L8N 3Z5 | Canada |
| Children's Hospital of Eastern Ontario and Ottawa General Hospital | Ottawa | Ontario | K1H 8L1 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M5S 1B2 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| CHU Ste. Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | Quebec | G1L 3L5 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Oulu University Central Hospital | Oulu | Finland |
| University Children's Hospital | Tübingen | Germany |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Bnai-Zion Medical Center | Haifa | 31048 | Israel |
| Meir Medical Center | Kfar Saba | 44281 | Israel |
| Schmidt B, Roberts RS, Whyte RK, Asztalos EV, Poets C, Rabi Y, Solimano A, Nelson H; Canadian Oxygen Trial Group. Impact of study oximeter masking algorithm on titration of oxygen therapy in the Canadian oxygen trial. J Pediatr. 2014 Oct;165(4):666-71.e2. doi: 10.1016/j.jpeds.2014.05.028. Epub 2014 Jun 25. |
| 34428130 | Derived | Jensen EA, Whyte RK, Schmidt B, Bassler D, Vain NE, Roberts RS; Canadian Oxygen Trial Investigators. Association between Intermittent Hypoxemia and Severe Bronchopulmonary Dysplasia in Preterm Infants. Am J Respir Crit Care Med. 2021 Nov 15;204(10):1192-1199. doi: 10.1164/rccm.202105-1150OC. |