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Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

2014-08-27 03:13:16 | BioPortfolio

Summary

The purpose of this trial is to determine, at 3 years of life, how the neurologic and functional outcomes in infants with single ventricles are different when comparing children treated with the Hybrid strategy to the Norwood strategy.

Description

Neurologic deficits in children with single ventricle physiology are believed to be associated with the reconstruction of the aortic arch during the initial Norwood procedure as a neonate. In the last few years, a new management strategy (the 'Hybrid' strategy) has been proposed which defers the aortic arch reconstruction to a second stage procedure at 4-6 months of age.

Proponents of the Hybrid strategy assert that the avoidance of cardiopulmonary bypass and circulatory arrest in the neonatal period will avoid neurologic injury in the critical neonatal period and thereby result in superior long-term neurologic outcomes.

We are testing whether the Hybrid management strategy is associated with superior neurologic outcomes or not.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Congenital Heart Disease

Intervention

Norwood management strategy, Hybrid Strategy

Location

The Hospital for Sick Children
Toronto
Ontario
Canada

Status

Recruiting

Source

The Hospital for Sick Children

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:16-0400

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