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Trial record 1 of 1 for:    23045213 [PUBMED-IDS]
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Age of Red Blood Cells in Premature Infants Study (ARIPI)

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ClinicalTrials.gov Identifier: NCT00326924
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : January 19, 2018
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Premature Birth
Intervention Biological: Transfusion
Enrollment 377
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Period Title: Overall Study
Started 188 189
Completed 187 188
Not Completed 1 1
Arm/Group Title Biological Standard PRBCs Total
Hide Arm/Group Description

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Total of all reporting groups
Overall Number of Baseline Participants 188 189 377
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 188 participants 189 participants 377 participants
10.0  (9.7) 9.9  (9.5) 10  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 189 participants 377 participants
Female
79
  42.0%
95
  50.3%
174
  46.2%
Male
109
  58.0%
94
  49.7%
203
  53.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Mothers' characteristics Number Analyzed 188 participants 189 participants 377 participants
White
138
  73.4%
123
  65.1%
261
  69.2%
Black
17
   9.0%
24
  12.7%
41
  10.9%
Latin American
4
   2.1%
1
   0.5%
5
   1.3%
Asian
6
   3.2%
8
   4.2%
14
   3.7%
Aboriginal
10
   5.3%
20
  10.6%
30
   8.0%
Filipino
0
   0.0%
4
   2.1%
4
   1.1%
Arab
3
   1.6%
1
   0.5%
4
   1.1%
Other or unknown
10
   5.3%
8
   4.2%
18
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 188 participants 189 participants 377 participants
188 189 377
1.Primary Outcome
Title 1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description:

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Overall Number of Participants Analyzed 188 189
Measure Type: Number
Unit of Measure: participants
99 100
2.Secondary Outcome
Title Clinically Suspected Infection and Culturally Confirmed Infections
Hide Description Infection was categorized as clinically suspected and positive cultures.
Time Frame 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description:

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Overall Number of Participants Analyzed 188 189
Measure Type: Number
Unit of Measure: number of participants
146 146
3.Secondary Outcome
Title Length of Stay
Hide Description Length of Stay in neonatal intensive unit
Time Frame until last participants left neonatal intensive care unit
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description:

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Overall Number of Participants Analyzed 188 189
Mean (Inter-Quartile Range)
Unit of Measure: number of days
84
(50 to 104)
77
(50 to 104)
4.Secondary Outcome
Title Number of Participants Using Mechanical Ventilation.
Hide Description Number of Participants using Mechanical Ventilation
Time Frame whether a mechanical ventilation was used at any time point during 90 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description:

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

Overall Number of Participants Analyzed 188 189
Measure Type: Number
Unit of Measure: participants
151 153
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Biological Standard PRBCs
Hide Arm/Group Description

PRBCs that are less than 7 days old are considered 'fresh'.

Transfusion: PRBC blood transfusions.

PRBCs 'stored' as per hospital policy.

Transfusion: PRBC blood transfusions.

All-Cause Mortality
Biological Standard PRBCs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Biological Standard PRBCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/188 (0.00%)      1/189 (0.53%)    
Infections and infestations     
cytomegalovirus infection * [1]  0/188 (0.00%)  0 1/189 (0.53%)  1
*
Indicates events were collected by non-systematic assessment
[1]
One serious adverse event potentially related to transfusion was a diagnosis of cytomegalovirus infection in an infant randomized to the standard red cell group.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biological Standard PRBCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/188 (0.00%)      0/189 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dean Fergusson, Senior Scientist
Organization: Ottawa Hospital Research Institute
Phone: 613-737-8480
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00326924     History of Changes
Other Study ID Numbers: 2004706-01H
First Submitted: May 15, 2006
First Posted: May 17, 2006
Results First Submitted: March 13, 2017
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018