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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00326924
• Other study ID #: 2004706-01H
• Status: Completed
• Phase: N/A
• First received: May 15, 2006
• Last updated: January 17, 2018
• Start date: May 2006
• Est. completion date: June 2012

Study information

• Verified date: January 2018
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth

Intervention

Biological:
• Transfusion
PRBC blood transfusions.

Locations

Country	Name	City	State
Canada	Ottawa Hospital	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Composite Outcome of Necrotizing Enterocolitis, Intraventricular Hemorrhage, Bronchopulmonary Dysplasia and Retinopathy of Prematurity at 30 and 90-days. 2. Mortality	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	Clinically Suspected Infection and Culturally Confirmed Infections	Infection was categorized as clinically suspected and positive cultures.	90 days
Secondary	Length of Stay	Length of Stay in neonatal intensive unit	until last participants left neonatal intensive care unit
Secondary	Number of Participants Using Mechanical Ventilation.	Number of Participants using Mechanical Ventilation	whether a mechanical ventilation was used at any time point during 90 days