Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

Phase 3

• Conditions: Congenital Heart Disease
• Interventions: Procedure: Hybrid Strategy; Procedure: Norwood management strategy

• Registration Number: NCT01134302
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-23
• Status Verified: 2010-05
• Study First Submitted QC: 2010-05-27
• Last Update Submitted: 2010-05-27
• Study First Posted: 2010-05-31
• Last Update Posted: 2010-05-31
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Hybrid Strategy	Hybrid Management
Arm 2	Norwood management strategy	Norwood Management

Primary Outcome Measures

Name	Time	Method
Neurologic and functional outcomes	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

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada