Premature Birth
Conditions
Keywords
Transfusion
Brief summary
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
Interventions
BIOLOGICALTransfusion
PRBC blood transfusions.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 37 Weeks
Healthy volunteers
No
Inclusion criteria
* birthweight of less than 1250g * admitted to participating NICU * consent acquired from proxy for the patient
Exclusion criteria
* already received one or more transfusions * requirement for an exchange transfusion * will be receiving directed donations * have rare blood types/difficult cross-match * proxy has refused consent * moribund on admission to NICU/expected to die * mitigating child protection issues
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | 2 weeks, 4 weeks, 12 weeks, 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Suspected Infection and Culturally Confirmed Infections | 90 days | Infection was categorized as clinically suspected and positive cultures. |
| Length of Stay | until last participants left neonatal intensive care unit | Length of Stay in neonatal intensive unit |
| Number of Participants Using Mechanical Ventilation. | whether a mechanical ventilation was used at any time point during 90 days | Number of Participants using Mechanical Ventilation |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Biological PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions. | 188 |
| Standard PRBCs PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions. | 189 |
| Total | 377 |
Baseline characteristics
| Characteristic | Biological | Standard PRBCs | Total |
|---|---|---|---|
| Age, Continuous | 10.0 days STANDARD_DEVIATION 9.7 | 9.9 days STANDARD_DEVIATION 9.5 | 10 days STANDARD_DEVIATION 9.6 |
| Race/Ethnicity, Customized Mothers' characteristics Aboriginal | 10 Participants | 20 Participants | 30 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Arab | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Asian | 6 Participants | 8 Participants | 14 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Black | 17 Participants | 24 Participants | 41 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Filipino | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Latin American | 4 Participants | 1 Participants | 5 Participants |
| Race/Ethnicity, Customized Mothers' characteristics Other or unknown | 10 Participants | 8 Participants | 18 Participants |
| Race/Ethnicity, Customized Mothers' characteristics White | 138 Participants | 123 Participants | 261 Participants |
| Region of Enrollment Canada | 188 participants | 189 participants | 377 participants |
| Sex: Female, Male Female | 79 Participants | 95 Participants | 174 Participants |
| Sex: Female, Male Male | 109 Participants | 94 Participants | 203 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 188 | 0 / 189 |
| serious Total, serious adverse events | 0 / 188 | 1 / 189 |
Outcome results
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.
Time frame: 2 weeks, 4 weeks, 12 weeks, 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biological | 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | 99 participants |
| Standard PRBCs | 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality | 100 participants |
Secondary
Clinically Suspected Infection and Culturally Confirmed Infections
Infection was categorized as clinically suspected and positive cultures.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biological | Clinically Suspected Infection and Culturally Confirmed Infections | 146 number of participants |
| Standard PRBCs | Clinically Suspected Infection and Culturally Confirmed Infections | 146 number of participants |
Secondary
Length of Stay
Length of Stay in neonatal intensive unit
Time frame: until last participants left neonatal intensive care unit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Biological | Length of Stay | 84 number of days |
| Standard PRBCs | Length of Stay | 77 number of days |
Secondary
Number of Participants Using Mechanical Ventilation.
Number of Participants using Mechanical Ventilation
Time frame: whether a mechanical ventilation was used at any time point during 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Biological | Number of Participants Using Mechanical Ventilation. | 151 participants |
| Standard PRBCs | Number of Participants Using Mechanical Ventilation. | 153 participants |