Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

The Hospital for Sick Children

Status and phase: Unknown; Phase 3

Conditions: Congenital Heart Disease

Treatments: Procedure: Hybrid Strategy; Procedure: Norwood management strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01134302

1000013962

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Arm 1

Active Comparator group

Description:

Hybrid Management

Treatment:

Procedure: Hybrid Strategy

Arm 2

Active Comparator group

Description:

Norwood Management

Treatment:

Procedure: Norwood management strategy