NCT01134302

Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

The Influence of Postoperative Systemic Oxygen Transport on Neurologic and Functional Outcomes in Infants Undergoing Single Ventricle Palliation With Norwood and Hybrid Management Strategies

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Norwood management strategy	Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
PROCEDURE	Hybrid Strategy	Hybrid palliation will be performed as per current clinical practice at The Hospital for Sick Children. The 'Hybrid' management strategy utilizes catheter-based and non-open heart surgical procedures in the neonatal period to stabilize the neonate.10 The majority of the reconstruction is thereby deferred to 4-6 months of age, at which time the second stage procedure including an aortic arch reconstruction is performed. The third stage procedure (Fontan) is identical between Norwood and Hybrid strategies.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-05-31
• Last updated: 2010-05-31

Locations

1 site across 1 country: Canada