Clinical trial NCT01134302: 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
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Congenital Heart Disease
Keywords: Hybrid
Norwood
congenital heart disease
single ventricle
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 50
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Neurologic and functional outcomes
timeFrame: 14 months of age
measure: Neurologic and functional outcomes
timeFrame: 3 years of age (during procedure 3 pre-op)
Secondary outcomes:
measure: Hemodynamic Assessment
timeFrame: Baseline and 4-6 months
measure: Blood Sampling
timeFrame: Baseline and 4-6 months
measure: Systemic Oxygen Consumption
timeFrame: Baseline and 4-6 months
measure: Cerebral Oxygen Transport Surrogate Measurements
timeFrame: Baseline and 4-6 months
measure: Cerebral Blood Flow Velocity
timeFrame: Baseline and 4-6 months
measure: Electroencephalograph
timeFrame: Baseline and 4-6 months
measure: MRI scans
timeFrame: Baseline, 4-6 months and 2-3 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Christopher Caldarone
role: PRINCIPAL_INVESTIGATOR
References: