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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
  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
Biological: Transfusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Age of Red Blood Cells in Premature Infants Study (ARIPI)

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital 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 [ Time Frame: 2 weeks, 4 weeks, 12 weeks, 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 377
Study Start Date: May 2006
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biological
PRBCs that are less than 7 days old are considered 'fresh'.
Biological: Transfusion
PRBC blood transfusions.
Other Name: non applicable
Experimental: Standard PRBCs
PRBCs 'stored' as per hospital policy.
Biological: Transfusion
PRBC blood transfusions.
Other Name: non applicable

  Eligibility

Ages Eligible for Study:   up to 37 Weeks
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
  • mitigating child protection issues
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326924

Locations
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
Study Director: Dean Fergusson, PhD OHRI
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT00326924     History of Changes
Other Study ID Numbers: 2004706-01H
Study First Received: May 15, 2006
Last Updated: November 2, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
Transfusion

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 23, 2014