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To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological | Experimental | PRBCs that are less than 7 days old are considered 'fresh'. |
|
| Standard PRBCs | Experimental | PRBCs 'stored' as per hospital policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transfusion | Biological | PRBC blood transfusions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. | 2 weeks, 4 weeks, 12 weeks, 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Suspected Infection and Culturally Confirmed Infections | Infection was categorized as clinically suspected and positive cultures. | 90 days |
| Length of Stay | Length of Stay in neonatal intensive unit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dean Fergusson, PhD | OHRI | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23874777 | Derived | Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013. | |
| 23045213 | Derived | Fergusson DA, Hebert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, Lachance C, Lee S, Walker CR, Hutton B, Ducharme R, Balchin K, Ramsay T, Ford JC, Kakadekar A, Ramesh K, Shapiro S. Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial. JAMA. 2012 Oct 10;308(14):1443-51. doi: 10.1001/2012.jama.11953. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Biological | PRBCs that are less than 7 days old are considered 'fresh'. Transfusion: PRBC blood transfusions. |
| FG001 | Standard PRBCs | PRBCs 'stored' as per hospital policy. Transfusion: PRBC blood transfusions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Biological | PRBCs that are less than 7 days old are considered 'fresh'. Transfusion: PRBC blood transfusions. |
| BG001 | Standard PRBCs | PRBCs 'stored' as per hospital policy. Transfusion: PRBC blood transfusions. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | The primary outcome was a composite outcome composed of mortality and major neonatal morbidities associated with acute organ dysfunction or failure. In addition to death, the 4 major morbidities comprising the composite outcome were bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and intraventricular hemorrhage. | Posted | Number | participants | 2 weeks, 4 weeks, 12 weeks, 90 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Biological | PRBCs that are less than 7 days old are considered 'fresh'. Transfusion: PRBC blood transfusions. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cytomegalovirus infection | Infections and infestations | Non-systematic Assessment | One serious adverse event potentially related to transfusion was a diagnosis of cytomegalovirus infection in an infant randomized to the standard red cell group. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dean Fergusson, Senior Scientist | Ottawa Hospital Research Institute | 613-737-8480 | dafergusson@ohri.ca |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D001803 | Blood Transfusion |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| until last participants left neonatal intensive care unit |
| Number of Participants Using Mechanical Ventilation. | Number of Participants using Mechanical Ventilation | whether a mechanical ventilation was used at any time point during 90 days |
| 19056034 | Derived | Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, Sankaran K, Shapiro S, Smyth JA, Ramesh K, Bouali NR, Tinmouth A, Walker R. The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design. Transfus Med Rev. 2009 Jan;23(1):55-61. doi: 10.1016/j.tmrv.2008.09.005. |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|
| Secondary | Clinically Suspected Infection and Culturally Confirmed Infections | Infection was categorized as clinically suspected and positive cultures. | Posted | Number | number of participants | 90 days |
|
|
|
| Secondary | Length of Stay | Length of Stay in neonatal intensive unit | Posted | Mean | Inter-Quartile Range | number of days | until last participants left neonatal intensive care unit |
|
|
|
| Secondary | Number of Participants Using Mechanical Ventilation. | Number of Participants using Mechanical Ventilation | Posted | Number | participants | whether a mechanical ventilation was used at any time point during 90 days |
|
|
|
| 0 |
| 188 |
| 0 |
| 188 |
| EG001 | Standard PRBCs | PRBCs 'stored' as per hospital policy. Transfusion: PRBC blood transfusions. | 1 | 189 | 0 | 189 |
|
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| D000091642 | Urogenital Diseases |