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| ID | Type | Description | Link |
|---|---|---|---|
| CIHR MCT-41549 | |||
| CIHR MCT-58455 |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
Hypothesis: That a high hemoglobin threshold for transfusion in extremely low birth weight (ELBW) infants is associated with a lower rate of survival without severe morbidity (defined as one or more of retinopathy of prematurity, bronchopulmonary dysplasia, or periventricular leukomalacia/ventriculomegaly).
Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.
Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Combined mortality or survival to tertiary hospital discharge without severe morbidity (BPD, severe ROP or brain injury) | neonatal phase | |
| Combined mortality or survival with neurodevelopmental disability (non-ambulatory cerebral palsy, blindness, deafness, cognitive delay) | follow-up phase 18 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| growth in weight and head circumference | neonatal phase | |
| time to extubation | neonatal phase | |
| time on oxygen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haresh Kirpalani, MD, MSc | McMaster University | Principal Investigator |
| Robin K Whyte, MD | Dalhousie University | Principal Investigator |
| Robin S Roberts, MTech | McMaster University | Study Director |
| Elizabeth Asztalos, MD, MSc | Sunnybrook & Women's College Health Sciences Centre | Study Director |
| Chad Andersen, MD | Mercy Hospital for Women | Study Director |
| Morris Blajchman, PhD | McMaster University | Study Director |
| Nancy Heddle, MSc | McMaster University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical Center | Albany | New York | 12208 | United States | ||
| Brooklyn Hospital Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16939737 | Result | Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011. | |
| 19117884 |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D001997 | Bronchopulmonary Dysplasia |
| D007969 | Leukomalacia, Periventricular |
| D006849 | Hydrocephalus |
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| neonatal phase |
| length of hospital stay until discharge home | neonatal phase |
| confirmed necrotizing enterocolitis | neonatal phase |
| apnea requiring treatment | neonatal phase |
| culture-proven infections | neonatal phase |
| use of post-natal steroids | neonatal phase |
| mean levels of hemoglobin | neonatal phase |
| number of transfusions | neonatal phase |
| number of donor exposures | neonatal phase |
| serum ferritin levels | neonatal phase |
| milder forms of cerebral palsy | follow-up phase 18 months corrected age |
| milder neurologic disorder | follow-up phase 18 months corrected age |
| personal and social functional capabilities | follow-up phase 18 months corrected age |
| hydrocephalus requiring a shunt | follow-up phase 18 months corrected age |
| seizure disorder | follow-up phase 18 months corrected age |
| respiratory disease | follow-up phase 18 months corrected age |
| iron nutritional status | follow-up phase 18 months corrected age |
| physical growth including head size | follow-up phase 18 months corrected age |
| Brooklyn |
| New York |
| 11201 |
| United States |
| Royal Women's Hospital | Melbourne | Victoria | 3053 | Australia |
| Mercy Hospital for Women | Melbourne | Victoria | 3084 | Australia |
| Royal Alexandra Hospital | Edmonton | Alberta | T5H 3T9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3P 1R8 | Canada |
| McMaster University | Hamilton | Ontario | L8S 4J9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Sunnybrook & Women's College Health Science Centre | Toronto | Ontario | M5S 1B2 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| Result |
| Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338. |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004678 | Encephalomalacia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |