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Age of Red Blood Cells in Premature Infants Study (ARIPI)
This study is currently recruiting participants.
Verified by Ottawa Health Research Institute, July 2007
Sponsored by: Ottawa Health Research Institute
Information provided by: Ottawa Health Research Institute
ClinicalTrials.gov Identifier: NCT00326924
  Purpose

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


Condition Intervention
Premature Birth
 Procedure: blood transfusion

MedlinePlus related topics: Blood Transfusion and Donation Premature Babies
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Age of Red Blood Cells in Premature Infants Study (ARIPI)

Further study details as provided by Ottawa Health Research Institute:

Primary Outcome Measures:
  • 1. composite outcome of necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia and retinopathy of prematurity at 30 and 90-days. 2. mortality

Secondary Outcome Measures:
  • 1. individual rates of necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia and retinopathy of prematurity at 30 and 90 days. 2. incidence of nosocomial infection 3. length of stay in NICU 4. length of mechanical ventilation

Estimated Enrollment: 450
Study Start Date: May 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00326924

Locations
Canada, Ontario
Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Dean Fergusson, PhD     613-737-8480     dafergusson@ohri.ca    
Contact: Brian Hutton, MSc     613-737-8122     bhutton@ohri.ca    
Principal Investigator: Dean A Fergusson, MHA, PhD            
Sponsors and Collaborators
Ottawa Health Research Institute
Investigators
Study Director: Dean Fergusson, PhD OHRI
  More Information

Publications indexed to this study:
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.

Study ID Numbers: 2004706-01H
Study First Received: May 15, 2006
Last Updated: July 25, 2007
ClinicalTrials.gov Identifier: NCT00326924  
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Health Research Institute:
Transfusion

Study placed in the following topic categories:
Pregnancy Complications
Obstetric Labor, Premature
Obstetric Labor Complications
Premature Birth

ClinicalTrials.gov processed this record on January 14, 2009



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