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

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.
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):

Study Description
Brief Summary:
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

Condition or disease Intervention/treatment
Premature Birth Biological: Transfusion

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
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)
Study Start Date : May 2006
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinically Suspected Infection and Culturally Confirmed Infections [ Time Frame: 90 days ]
    Infection was categorized as clinically suspected and positive cultures.

  2. Length of Stay [ Time Frame: until last participants left neonatal intensive care unit ]
    Length of Stay in neonatal intensive unit

  3. 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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: May 17, 2006    Key Record Dates
Results First Posted: January 19, 2018
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Ottawa Hospital Research Institute:
Transfusion

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