Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
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|ClinicalTrials.gov Identifier: NCT01134302|
Recruitment Status : Unknown
Verified May 2010 by The Hospital for Sick Children.
Recruitment status was: Recruiting
First Posted : May 31, 2010
Last Update Posted : May 31, 2010
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease||Procedure: Norwood management strategy Procedure: Hybrid Strategy||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2012|
|Estimated Study Completion Date :||March 2012|
Active Comparator: Arm 1
Procedure: 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.
Active Comparator: Arm 2
Procedure: Norwood management strategy
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
- Neurologic and functional outcomes [ Time Frame: 14 months of age ]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 [ Time Frame: 3 years of age (during procedure 3 pre-op) ]At ~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed
- Hemodynamic Assessment [ Time Frame: Baseline and 4-6 months ]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 [ Time Frame: Baseline and 4-6 months ]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 [ Time Frame: Baseline and 4-6 months ]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 [ Time Frame: Baseline and 4-6 months ]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 [ Time Frame: Baseline and 4-6 months ]
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 [ Time Frame: Baseline and 4-6 months ]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 [ Time Frame: Baseline, 4-6 months and 2-3 years ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134302
|Contact: Christopher Caldaroneemail@example.com|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Christopher Caldarone 416-813-6420 firstname.lastname@example.org|
|Contact: Glen VanArsdell 416-813-6420 email@example.com|
|Principal Investigator: Christopher Caldarone, MD|
|Principal Investigator:||Christopher Caldarone||The Hospital for Sick Children, Toronto Canada|