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

Not Applicable

Completed

• Conditions: Premature Birth
• Interventions: Biological: Transfusion

• Registration Number: NCT00326924
• Lead Sponsor: Ottawa Hospital Research Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-05-15
• Study First Submitted QC: 2006-05-15
• Study First Posted: 2006-05-17
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2017-03-13
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-17
• Last Update Submitted: 2018-01-17
• Results First Posted: 2018-01-19
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biological	Transfusion	PRBCs that are less than 7 days old are considered 'fresh'.
Standard PRBCs	Transfusion	PRBCs 'stored' as per hospital policy.

Primary Outcome Measures

Name	Time	Method
1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality	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

Name	Time	Method
Clinically Suspected Infection and Culturally Confirmed Infections	90 days	Infection was categorized as clinically suspected and positive cultures.
Length of Stay	until last participants left neonatal intensive care unit	Length of Stay in neonatal intensive unit
Number of Participants Using Mechanical Ventilation.	whether a mechanical ventilation was used at any time point during 90 days	Number of Participants using Mechanical Ventilation

Trial Locations

Locations (1)

Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada