Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
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)
Links
- Source: http://clinicaltrials.gov/show/NCT01134302
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Norwood Procedures
A set of surgical procedures performed to establish sufficient outflow to the systemic circulation in individuals with univentricular congenital heart malformations, such as HYPOPLASTIC LEFT HEART SYNDROME, and MITRAL VALVE atresia, associated with systemic outflow obstruction. Follow-on surgeries may be performed and consist of a HEMI-FONTAN PROCEDURE as the stage 2 Norwood procedure and a FONTAN PROCEDURE as the stage 3 Norwood procedure.
Managed Competition
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)
Intention To Treat Analysis
Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.
Carcinoma, Non-small-cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
Two-hybrid System Techniques
Screening techniques first developed in yeast to identify genes encoding interacting proteins. Variations are used to evaluate interplay between proteins and other molecules. Two-hybrid techniques refer to analysis for protein-protein interactions, one-hybrid for DNA-protein interactions, three-hybrid interactions for RNA-protein interactions or ligand-based interactions. Reverse n-hybrid techniques refer to analysis for mutations or other small molecules that dissociate known interactions.
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PubMed Articles
We describe a patient with a variant of the hypoplastic left heart syndrome who died 16 weeks after a modified stage 1 Norwood from a mitochondrial DNA depletion syndrome.
OBJECTIVE: We perform bilateral pulmonary artery banding (BPAB) combined with postoperative percutaneous pulmonary artery balloon dilatation (PABD) as stage I palliation for severe congenital heart di...
Improving surgical outcome following the Norwood procedure.
BACKGROUND: The Norwood procedure consists of three palliative operations, performed in neonates with hypoplastic left heart syndrome. Especially the first stage (Norwood I) is associated with the hig...
OBJECTIVE: The hybrid stage I procedure is an alternative palliative strategy for patients with hypoplastic left heart syndrome who traditionally have undergone the Norwood operation. At our instituti...
