Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
NCT ID: NCT01134302
Last Updated: 2010-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
50 participants
INTERVENTIONAL
2010-03-31
2012-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Arm 1
Hybrid Management
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.
Arm 2
Norwood Management
Norwood management strategy
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
Interventions
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Norwood management strategy
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
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.
Eligibility Criteria
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Inclusion Criteria
2. Informed consent of parent(s) or legal guardian.
Exclusion Criteria
2. Recent history of significant cerebral bleed or necrotizing enterocolitis;
3. Severe hemodynamic instability;
4. Any other major congenital abnormality (i.e. congenital diaphragmatic hernia, tracheoesophageal fistula) or clinically significant acquired extra-cardiac disorder (e.g. meconium aspiration with need for high frequency ventilation, persistent renal failure requiring dialysis).
3 Months
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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The Hospital for Sick Children
Principal Investigators
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Christopher Caldarone
Role: PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto Canada
Locations
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The Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Christopher Caldarone
Role: primary
Glen VanArsdell
Role: backup
Related Links
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Related Info
Related Info
Other Identifiers
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1000013962
Identifier Type: -
Identifier Source: org_study_id