Back to resultsHybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
Primary Purpose
Congenital Heart Disease
Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Norwood management strategy
Hybrid Strategy
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Hybrid, Norwood, congenital heart disease, single ventricle
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation.
- Informed consent of parent(s) or legal guardian.
Exclusion Criteria:
- Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate;
- Recent history of significant cerebral bleed or necrotizing enterocolitis;
- Severe hemodynamic instability;
- 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).
Sites / Locations
- The Hospital for Sick ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Hybrid Management
Norwood Management
Outcomes
Primary Outcome Measures
Neurologic and functional outcomes
Neurodevelopmental and functional status will be assessed at 14 months of age using the Bayley Scales of Infant Development®-Third Edition (BSID-III), MacArthur Commmunicative Development Inventory/Words and Gestures (CDI) and Functional Status-II-Revised Questionnaire.
Neurologic and functional outcomes
At ~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed
Secondary Outcome Measures
Hemodynamic Assessment
Arterial, superior vena cava and pulmonary vein pressure will be monitored via indwelling catheters. This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Blood Sampling
Standard blood gas samples will be drawn from indwelling arterial, SVC and pulmonary vein catheters to provide oxygen saturation and lactate data. This measurement will be taken immediately after chest opening, and then postoperatively at 2 hour intervals during the first 24 hours and at 4 hour intervals during the following 48 hours after first and second stage procedures.
Systemic Oxygen Consumption
Measurement of pre- and post-operative VO2. This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, and procedure 2 pre-op
Cerebral Oxygen Transport Surrogate Measurements
Cerebral oxygen saturation (ScO2) will be continuously measured by Near Infrared Spectroscopy (NIRS). This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Cerebral Blood Flow Velocity
Transcranial Doppler sonography using the TCD through the middle cerebral artery with a 2 MHz pulse-wave ultrasound transducer will be used to measure cerebral blood flow velocity non-invasively.
This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Electroencephalograph
Locked digital video electroencephalography (DVEEG) will be used to continuously monitor ischemic injury and seizures. This will be done at the folling times: procedure 1 pre-op, procedure 1 post-op prior to discharge, and procedure 2 post-op.
MRI scans
Brain imaging will be assessed for evidence of congenital malformations or structural abnormalities, cerebral edema, acute ischemia, intracranial hemorrhages, periventricular leukomalacia (PVL), focal tissue loss, atrophy, delays in myelin maturation and infarcts.
The MRI will be done during procedure 1 post-op prior to discharge, procedure 2 post-op prior to discharge and procedure 3 pre-op.
Full Information
NCT ID
NCT01134302
First Posted
March 23, 2010
Last Updated
May 27, 2010
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01134302
Brief Title
Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
Official Title
The Influence of Postoperative Systemic Oxygen Transport on Neurologic and Functional Outcomes in Infants Undergoing Single Ventricle Palliation With Norwood and Hybrid Management Strategies
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Hybrid, Norwood, congenital heart disease, single ventricle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
Hybrid Management
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Norwood Management
Intervention Type
Procedure
Intervention Name(s)
Norwood management strategy
Intervention Description
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
Intervention Type
Procedure
Intervention Name(s)
Hybrid Strategy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurologic and functional outcomes
Description
Neurodevelopmental and functional status will be assessed at 14 months of age using the Bayley Scales of Infant Development®-Third Edition (BSID-III), MacArthur Commmunicative Development Inventory/Words and Gestures (CDI) and Functional Status-II-Revised Questionnaire.
Time Frame
14 months of age
Title
Neurologic and functional outcomes
Description
At ~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed
Time Frame
3 years of age (during procedure 3 pre-op)
Secondary Outcome Measure Information:
Title
Hemodynamic Assessment
Description
Arterial, superior vena cava and pulmonary vein pressure will be monitored via indwelling catheters. This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Time Frame
Baseline and 4-6 months
Title
Blood Sampling
Description
Standard blood gas samples will be drawn from indwelling arterial, SVC and pulmonary vein catheters to provide oxygen saturation and lactate data. This measurement will be taken immediately after chest opening, and then postoperatively at 2 hour intervals during the first 24 hours and at 4 hour intervals during the following 48 hours after first and second stage procedures.
Time Frame
Baseline and 4-6 months
Title
Systemic Oxygen Consumption
Description
Measurement of pre- and post-operative VO2. This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, and procedure 2 pre-op
Time Frame
Baseline and 4-6 months
Title
Cerebral Oxygen Transport Surrogate Measurements
Description
Cerebral oxygen saturation (ScO2) will be continuously measured by Near Infrared Spectroscopy (NIRS). This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Time Frame
Baseline and 4-6 months
Title
Cerebral Blood Flow Velocity
Description
Transcranial Doppler sonography using the TCD through the middle cerebral artery with a 2 MHz pulse-wave ultrasound transducer will be used to measure cerebral blood flow velocity non-invasively.
This measurement will be taken during: procedure 1 pre-op, procedure 1 post-op, procedure 2 pre-op, and procedure 2 post-op.
Time Frame
Baseline and 4-6 months
Title
Electroencephalograph
Description
Locked digital video electroencephalography (DVEEG) will be used to continuously monitor ischemic injury and seizures. This will be done at the folling times: procedure 1 pre-op, procedure 1 post-op prior to discharge, and procedure 2 post-op.
Time Frame
Baseline and 4-6 months
Title
MRI scans
Description
Brain imaging will be assessed for evidence of congenital malformations or structural abnormalities, cerebral edema, acute ischemia, intracranial hemorrhages, periventricular leukomalacia (PVL), focal tissue loss, atrophy, delays in myelin maturation and infarcts.
The MRI will be done during procedure 1 post-op prior to discharge, procedure 2 post-op prior to discharge and procedure 3 pre-op.
Time Frame
Baseline, 4-6 months and 2-3 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation.
Informed consent of parent(s) or legal guardian.
Exclusion Criteria:
Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate;
Recent history of significant cerebral bleed or necrotizing enterocolitis;
Severe hemodynamic instability;
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher Caldarone
Phone
416-813-6420
Email
christopher.caldarone@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Caldarone
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Caldarone
Phone
416-813-6420
Email
christopher.caldarone@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Glen VanArsdell
Phone
416-813-6420
Email
glen.vanarsdell@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Christopher Caldarone, MD
12. IPD Sharing Statement
Links:
URL
http://www.sickkids.ca/Centres/heart-centre/index.html
Description
Related Info
URL
http://www.ctsnet.org/home/gvanarsdell
Description
Related Info
URL
http://www.sickkids.ca/Research/REB/index.html
Description
Related Info
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Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
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