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

January 17, 2018 updated by: Ottawa Hospital Research Institute
To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

377

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biological
PRBCs that are less than 7 days old are considered 'fresh'.
Biological: Transfusion
PRBC blood transfusions.
Other Names:
  • non applicable
Experimental: Standard PRBCs
PRBCs 'stored' as per hospital policy.
Biological: Transfusion
PRBC blood transfusions.
Other Names:
  • non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 weeks, 4 weeks, 12 weeks, 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Suspected Infection and Culturally Confirmed Infections
Time Frame: 90 days
Infection was categorized as clinically suspected and positive cultures.
90 days
Length of Stay
Time Frame: until last participants left neonatal intensive care unit
Length of Stay in neonatal intensive unit
until last participants left neonatal intensive care 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
whether a mechanical ventilation was used at any time point during 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Investigators

  • Study Director: Dean Fergusson, PhD, OHRI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Actual)

January 19, 2018

Last Update Submitted That Met QC Criteria

January 17, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004706-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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