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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00326924
First received: May 15, 2006
Last updated: November 2, 2014
Last verified: November 2014

May 15, 2006
November 2, 2014
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 ] [ Designated as safety issue: Yes ]
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
1. individual rates of NEC, IVH, BPD and ROP at 30 and 90 days. 2. incidence of nosocomial infection 3. length of stay in NICU 4. length of mechanical ventilation [ Time Frame: 2 weeks, 4 weeks, 12 weeks, 90 days ] [ Designated as safety issue: Yes ]
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 Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
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
Both
up to 37 Weeks
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00326924
2004706-01H
Yes
Ottawa Hospital Research Institute
Ottawa Hospital Research Institute
Not Provided
Study Director: Dean Fergusson, PhD OHRI
Ottawa Hospital Research Institute
November 2014

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