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Age of Red Blood Cells in Premature Infants Study (ARIPI)

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Transfusion
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Transfusion

Eligibility Criteria

1 Minute - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ottawa Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Biological

Standard PRBCs

Arm Description

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

PRBCs 'stored' as per hospital policy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinically Suspected Infection and Culturally Confirmed Infections
Infection was categorized as clinically suspected and positive cultures.
Length of Stay
Length of Stay in neonatal intensive unit
Number of Participants Using Mechanical Ventilation.
Number of Participants using Mechanical Ventilation

Full Information

First Posted
May 15, 2006
Last Updated
January 17, 2018
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00326924
Brief Title
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Official Title
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological
Arm Type
Experimental
Arm Description
PRBCs that are less than 7 days old are considered 'fresh'.
Arm Title
Standard PRBCs
Arm Type
Experimental
Arm Description
PRBCs 'stored' as per hospital policy.
Intervention Type
Biological
Intervention Name(s)
Transfusion
Other Intervention Name(s)
non applicable
Intervention Description
PRBC blood transfusions.
Primary Outcome Measure Information:
Title
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
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
Secondary Outcome Measure Information:
Title
Clinically Suspected Infection and Culturally Confirmed Infections
Description
Infection was categorized as clinically suspected and positive cultures.
Time Frame
90 days
Title
Length of Stay
Description
Length of Stay in neonatal intensive unit
Time Frame
until last participants left neonatal intensive care unit
Title
Number of Participants Using Mechanical Ventilation.
Description
Number of Participants using Mechanical Ventilation
Time Frame
whether a mechanical ventilation was used at any time point during 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Fergusson, PhD
Organizational Affiliation
OHRI
Official's Role
Study Director
Facility Information:
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23874777
Citation
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.
Results Reference
derived
PubMed Identifier
23045213
Citation
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.
Results Reference
derived
PubMed Identifier
19056034
Citation
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.
Results Reference
derived

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Age of Red Blood Cells in Premature Infants Study (ARIPI)

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