Status:

COMPLETED

Canadian National PDA Treatment Study

Lead Sponsor:

IWK Health Centre

Collaborating Sponsors:

Provincial Health Services Authority British Columbia

Children's Hospital of Eastern Ontario

Conditions:

Patent Ductus Arteriosus

Extreme Prematurity

Eligibility:

All Genders

Up to 12 years

Brief Summary

Patent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in preterm infants. Persistent PDA may result in higher rates of death, chronic lung disease (CLD), pulmonary hem...

Detailed Description

In this study, we intend to generate real-world evidence (RWE) by analyzing real-world data (RWD) (defined as data generated during routine clinical practice) from a registry-based Comparative Effecti...

Eligibility Criteria

Inclusion

  • Extremely preterm infants (\<29 weeks gestational age) with an echocardiography confirmed PDA who will be treated according to attending team

Exclusion

  • Any infant who received pharmacotherapy for a clinically symptomatic PDA without prior echocardiographic confirmation of the presence of PDA will be excluded from all analyses.

Key Trial Info

Start Date :

January 1 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

1663 Patients enrolled

Trial Details

Trial ID

NCT04347720

Start Date

January 1 2020

End Date

December 31 2023

Last Update

June 21 2024

Active Locations (22)

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Page 1 of 6 (22 locations)

1

Foothills Medical Centre

Calgary, Alberta, Canada

2

Royal Alexandra Hospital

Edmonton, Alberta, Canada

3

Royal Columbian Hospital

New Westminster, British Columbia, Canada

4

British Columbia Women's Hospital

Vancouver, British Columbia, Canada