Recruiting
Phase 3

Hybrid vs. Norwood

Sponsor:

The Hospital for Sick Children

Code:

NCT01134302

Conditions

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Norwood management strategy

Hybrid Strategy

Study Details

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.

Conditions

Congenital Heart Disease

Study ID

NCT01134302

Start date

Mar, 2010

Status verified date

May, 2010

Completion date

Mar, 2012

Anticipated

Primary completion date

Mar, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1

Hybrid Management

active comparator: Arm 2

Norwood Management

Interventions

Norwood management strategy

Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.

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.

Primary outcome measure

  • Neurologic and functional outcomes [ Time Frame: 14 months of age ]
  • Neurologic and functional outcomes [ Time Frame: 3 years of age (during procedure 3 pre-op) ]

Central Contacts and Locations

Central contacts

Christopher Caldarone

416-813-6420christopher.caldarone@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada

Contacts

Christopher Caldarone

416-813-6420christopher.caldarone@sickkids.ca

Glen VanArsdell

416-813-6420glen.vanarsdell@sickkids.ca

Principal Investigator:

Christopher Caldarone, MD

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 31, 2010

Last verified

May, 2010

Keywords

  • Hybrid
  • Norwood
  • congenital heart disease
  • single ventricle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2010-05-31.