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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

May 15, 2006
May 17, 2006
March 13, 2017
January 19, 2018
January 19, 2018
May 2006
June 2012   (Final data collection date for primary outcome measure)
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality [ Time Frame: 2 weeks, 4 weeks, 12 weeks, 90 days ]
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.
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality
Complete list of historical versions of study NCT00326924 on ClinicalTrials.gov Archive Site
  • Clinically Suspected Infection and Culturally Confirmed Infections [ Time Frame: 90 days ]
    Infection was categorized as clinically suspected and positive cultures.
  • Length of Stay [ Time Frame: until last participants left neonatal intensive care unit ]
    Length of Stay in neonatal intensive unit
  • Number of Participants Using Mechanical Ventilation. [ Time Frame: whether a mechanical ventilation was used at any time point during 90 days ]
    Number of Participants using Mechanical Ventilation
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
Not Provided
Not Provided
 
Age of Red Blood Cells in Premature Infants Study (ARIPI)
Age of Red Blood Cells in Premature Infants Study (ARIPI)
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Premature Birth
Biological: Transfusion
PRBC blood transfusions.
Other Name: non applicable
  • Experimental: Biological
    PRBCs that are less than 7 days old are considered 'fresh'.
    Intervention: Biological: Transfusion
  • Experimental: Standard PRBCs
    PRBCs 'stored' as per hospital policy.
    Intervention: Biological: Transfusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
377
450
June 2012
June 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 37 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00326924
2004706-01H
Yes
Not Provided
Not Provided
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Study Director: Dean Fergusson, PhD OHRI
Ottawa Hospital Research Institute
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP