Congenital Heart Disease
Conditions
Keywords
Hybrid, Norwood, congenital heart disease, single ventricle
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.
Interventions
PROCEDURENorwood management strategy
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
PROCEDUREHybrid 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.
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of functional single ventricle anatomy amenable to Norwood or Hybrid first stage palliation. 2. Informed consent of parent(s) or legal guardian.
Exclusion criteria
1. Pre-operative identification of anatomy rendering either a Norwood or Hybrid procedure clinically inappropriate; 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurologic and functional outcomes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood Sampling | 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 | 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 | 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. |
| Hemodynamic Assessment | 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. |
| Electroencephalograph | 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 | 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. |
| Cerebral Blood Flow Velocity | 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. |
Countries
Canada
Contacts
Primary ContactChristopher Caldarone
Outcome results
None listed