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Age of Red blood cells In Premature Infants trial
ISRCTN ISRCTN65939658
DOI 10.1186/ISRCTN65939658
ClinicalTrials.gov identifier NCT00326924
EudraCT number
Public title Age of Red blood cells In Premature Infants trial
Scientific title Age of Red blood cells In Premature Infants: a multicentre, two arm, randomised parallel trial
Acronym ARIPI
Serial number at source MCT-75527
Study hypothesis The transfusion of red blood cells (RBCs) stored for less than or equal to seven days will decrease the incidence of a 90-day composite measure consisting of all-cause mortality and organ dysfunction including bronchopulmonary dysplasia, necrotising enterocolitis, intraventricular haemorrhage and retinopathy of prematurity in premature infants weighing less than or equal to 1250 grams.
Lay summary Not provided at time of registration
Ethics approval Research Ethics Board of The Ottawa Hospital, Ottawa, Ontario (Canada) approved on the 14th June 2006.
Study design Multicentre, two arm, randomised parallel trial with study participant, investigator, caregiver, outcome assessor and data analyst blinded
Countries of recruitment Canada
Disease/condition/study domain Premature infants weighing less than 1250 g admitted to the neonatal intensive care unit
Participants - inclusion criteria 1. Requirement of a second allogeneic RBC transfusion for the treatment of prematurity
2. Infant age 0 - 27 days, either sex
3. Less than 1250 grams birth weight
4. Admitted to the participating Neonatal Intensive Care Unit (NICU)
5. Parents or guardian have signed (proxy) informed consent
Participants - exclusion criteria 1. Infants whose first transfusion was older than seven days
2. Infants already given a second RBC transfusion
3. Infants scheduled to undergo an exchange transfusion
4. Infants that will receive directed donations
5. Infants that have rare blood types or difficulty with cross-matching
6. Infants whose proxy has refused consent
7. Infants who are moribund upon admission to the NICU or not expected to survive due to a severe congenital anomaly
Anticipated start date 01/05/2006
Anticipated end date 31/12/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 450
Interventions Experimental Group: transfusion of fresh blood stored less than or equal to seven days. Control Group: standard practice (blood stored up to 35 days).

In all sites but Saskatoon, O-Rh negative RBCs will be divided into satellite units of between four and eight aliquots, and these aliquots will be removed from their satellite units as needed in order to reduce wastage. Dose as per standard care/duration: up to 90 days.
Primary outcome measure(s) Composite outcome comprised of five major neonatal morbidities:
1. Necrotising enterocolitis
2. Retinopathy of prematurity
3. Bronchopulmonary dysplasia
4. Intraventricular hemorrhage
5. Mortality measured at 90 days
Secondary outcome measure(s) 1. Nosocomial infection
2. Individual rates of the morbidities comprising the primary outcome:
2.1. Necrotising enterocolitis
2.2. Retinopathy of prematurity
2.3. Bronchopulmonary dysplasia
2.4. Intraventricular hemorrhage
2.5. Death

Tertiary outcomes will include:
1. Length of mechanical ventilation
2. Length of stay in the NICU
3. Both minor and major interventions received while in the NICU
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75527)
Trial website
Publications 1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19056034
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23045213
Contact name Dr  Dean A  Fergusson
  Address Clinical Epidemiology Program
Ottawa Hospital Research Institute
501 Smyth Road, Box 201
Ottawa
  City/town Ontario
  Zip/Postcode K1H 8L6
  Country Canada
  Tel +1 613 737 8480
  Fax +1 613 739 6266
  Email dafergusson@ohri.ca
Sponsor Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute
  Address 725 Parkdale Avenue
Ottawa
  City/town Ontario
  Zip/Postcode K1Y 4E9
  Country Canada
  Tel +1 613 761 4395
  Email info@ohri.ca
  Sponsor website: http://www.ohri.ca/
Date applied 02/10/2006
Last edited 16/10/2012
Date ISRCTN assigned 02/10/2006
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