Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

Congenital Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01134302
• Other study ID #: 1000013962
• Status: Recruiting
• Phase: Phase 3
• First received: March 23, 2010
• Last updated: May 27, 2010
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2010
• Source: The Hospital for Sick Children
• Contact: Christopher Caldarone
• Phone: 416-813-6420
• Email: christopher.caldarone[@]sickkids.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurologic and functional outcomes	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.	14 months of age	No
Primary	Neurologic and functional outcomes	At ~3 years of age, the Vineland Scale,the Mullen Developmental Scale, and the BASC behavioural scale will be formally assessed	3 years of age (during procedure 3 pre-op)	No
Secondary	Hemodynamic Assessment	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.	Baseline and 4-6 months	No
Secondary	Blood Sampling	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.	Baseline and 4-6 months	No
Secondary	Systemic Oxygen Consumption	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	Baseline and 4-6 months	No
Secondary	Cerebral Oxygen Transport Surrogate Measurements	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.	Baseline and 4-6 months	No
Secondary	Cerebral Blood Flow Velocity	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.	Baseline and 4-6 months	No
Secondary	Electroencephalograph	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.	Baseline and 4-6 months	Yes
Secondary	MRI scans	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.	Baseline, 4-6 months and 2-3 years	No

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