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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.
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Congenital Heart Disease
Norwood management strategy, Hybrid Strategy
The Hospital for Sick Children
The Hospital for Sick Children
Published on BioPortfolio: 2014-08-27T03:13:16-0400
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A strategy for purchasing health care in a manner which will obtain maximum value for the price for the purchasers of the health care and the recipients. The concept was developed primarily by Alain Enthoven of Stanford University and promulgated by the Jackson Hole Group. The strategy depends on sponsors for groups of the population to be insured. The sponsor, in some cases a health alliance, acts as an intermediary between the group and competing provider groups (accountable health plans). The competition is price-based among annual premiums for a defined, standardized benefit package. (From Slee and Slee, Health Care Reform Terms, 1993)
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