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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00326924
First Posted: May 17, 2006
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: May 15, 2006
First Posted: May 17, 2006
Last Update Posted: October 12, 2017
Last Verified: November 2014

Keywords provided by Ottawa Hospital Research Institute:
Transfusion

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