Trial Outcomes & Findings for Age of Red Blood Cells in Premature Infants Study (ARIPI) (NCT NCT00326924)
NCT ID: NCT00326924
Last Updated: 2018-01-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
377 participants
Primary outcome timeframe
2 weeks, 4 weeks, 12 weeks, 90 days
Results posted on
2018-01-19
Participant Flow
Participant milestones
| Measure |
Biological
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
Overall Study
STARTED
|
188
|
189
|
|
Overall Study
COMPLETED
|
187
|
188
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Baseline characteristics by cohort
| Measure |
Biological
n=188 Participants
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 Participants
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
Total
n=377 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.0 days
STANDARD_DEVIATION 9.7 • n=5 Participants
|
9.9 days
STANDARD_DEVIATION 9.5 • n=7 Participants
|
10 days
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
109 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · White
|
138 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Black
|
17 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Latin American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Aboriginal
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Filipino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Arab
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mothers' characteristics · Other or unknown
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
188 participants
n=5 Participants
|
189 participants
n=7 Participants
|
377 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks, 12 weeks, 90 daysThe 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.
Outcome measures
| Measure |
Biological
n=188 Participants
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 Participants
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
|
99 participants
|
100 participants
|
SECONDARY outcome
Timeframe: 90 daysInfection was categorized as clinically suspected and positive cultures.
Outcome measures
| Measure |
Biological
n=188 Participants
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 Participants
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
Clinically Suspected Infection and Culturally Confirmed Infections
|
146 number of participants
|
146 number of participants
|
SECONDARY outcome
Timeframe: until last participants left neonatal intensive care unitLength of Stay in neonatal intensive unit
Outcome measures
| Measure |
Biological
n=188 Participants
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 Participants
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
Length of Stay
|
84 number of days
Interval 50.0 to 104.0
|
77 number of days
Interval 50.0 to 104.0
|
SECONDARY outcome
Timeframe: whether a mechanical ventilation was used at any time point during 90 daysNumber of Participants using Mechanical Ventilation
Outcome measures
| Measure |
Biological
n=188 Participants
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 Participants
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
Number of Participants Using Mechanical Ventilation.
|
151 participants
|
153 participants
|
Adverse Events
Biological
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard PRBCs
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Biological
n=188 participants at risk
PRBCs that are less than 7 days old are considered 'fresh'.
Transfusion: PRBC blood transfusions.
|
Standard PRBCs
n=189 participants at risk
PRBCs 'stored' as per hospital policy.
Transfusion: PRBC blood transfusions.
|
|---|---|---|
|
Infections and infestations
cytomegalovirus infection
|
0.00%
0/188
|
0.53%
1/189 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dean Fergusson, Senior Scientist
Ottawa Hospital Research Institute
Phone: 613-737-8480
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place