Advertisement

Topics

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

Clinical Trials [2910 Associated Clinical Trials listed on BioPortfolio]

Carbohydrate Antigen 125-guided Therapy in Heart Failure

Preliminary data suggest a potential role for monitoring and up-titrate pharmacological therapy of plasma levels of antigen carbohydrate 125 (CA125) following and admission for acute heart...

Parenteral Phenoxybenzamine During Congenital Heart Disease Surgery

Phenoxybenzamine, an irreversible alpha-adrenergic blocker, may prove beneficial to infants and children with congenital heart disease undergoing open cardiac repair, due to a theoretic be...

Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness (ESCAPE)

To compare the efficacy of Pulmonary Artery Catheterization (PAC)-directed treatment strategy to a non-invasive treatment strategy on morbidity and mortality in patients with severe, class...

Hybrid Closure of Congenital Heart Disease

Ventricular septal defect (VSD) is one of the most common pediatric congenital malformations. In recent years, in view of the rapid rise of transthoracic minimally invasive hybrid closure ...

4-D Visualization Using Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population

In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different comput...

PubMed Articles [32747 Associated PubMed Articles listed on BioPortfolio]

Temporary Single Ventricle Palliation for Severe Diastolic Dysfunction in a Biventricular Heart.

We describe a neonate with severe left ventricular (LV) dysfunction manifesting soon after birth, who required extracorporeal life support (ECLS). Multiple attempts at separation from ECLS resulted in...

Cardiac Embryology and Molecular Mechanisms of Congenital Heart Disease: A Primer for Anesthesiologists.

Congenital heart disease is diagnosed in 0.4% to 5% of live births and presents unique challenges to the pediatric anesthesiologist. Furthermore, advances in surgical management have led to improved s...

Use of Tolvaptan in a Patient With Palliated Congenital Heart Disease.

Heart failure is a common problem in the ever growing population of patients with palliated congenital heart disease. It is frequently complicated by hyponatremia that has been associated with increas...

Sleep-Disordered Breathing in Patients with Pulmonary Valve Incompetence Complicating Congenital Heart Disease.

Long standing pulmonary regurgitation results in deleterious effects on right heart size and function with late consequences of right heart volume overload including ventricular dilatation, propensity...

Relationship between TBX20 gene polymorphism and congenital heart disease.

Congenital heart disease in children is a type of birth defect. Previous studies have suggested that the transcription factor, TBX20, is involved in the occurrence and development of congenital heart ...

Medical and Biotech [MESH] Definitions

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.

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)

Strategy for the analysis of RANDOMIZED CONTROLLED TRIALS AS TOPIC that compares patients in the groups to which they were originally randomly assigned.

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.

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.

More From BioPortfolio on "Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation"

Quick Search
Advertisement
 

Relevant Topic

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial