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Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation

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ClinicalTrials.gov Identifier: NCT01134302
Recruitment Status : Unknown
Verified May 2010 by The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : May 31, 2010
Last Update Posted : May 31, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Congenital Heart Disease Procedure: Norwood management strategy Procedure: Hybrid Strategy Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : March 2010
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arm Intervention/treatment
Active Comparator: Arm 1
Hybrid Management
Procedure: 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.


Active Comparator: Arm 2
Norwood Management
Procedure: Norwood management strategy
Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.




Primary Outcome Measures :
  1. Neurologic and functional outcomes [ Time Frame: 14 months of age ]
    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.

  2. Neurologic and functional outcomes [ Time Frame: 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 :
  1. Hemodynamic Assessment [ Time Frame: 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.

  2. Blood Sampling [ Time Frame: 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.

  3. Systemic Oxygen Consumption [ Time Frame: 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

  4. Cerebral Oxygen Transport Surrogate Measurements [ Time Frame: 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.

  5. Cerebral Blood Flow Velocity [ Time Frame: 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.


  6. Electroencephalograph [ Time Frame: 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.

  7. MRI scans [ Time Frame: 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.




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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134302


Contacts
Contact: Christopher Caldarone 416-813-6420 christopher.caldarone@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Christopher Caldarone    416-813-6420    christopher.caldarone@sickkids.ca   
Contact: Glen VanArsdell    416-813-6420    glen.vanarsdell@sickkids.ca   
Principal Investigator: Christopher Caldarone, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Christopher Caldarone The Hospital for Sick Children, Toronto Canada

Additional Information:
Responsible Party: Christopher Caldarone, Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01134302     History of Changes
Other Study ID Numbers: 1000013962
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: May 31, 2010
Last Verified: May 2010

Keywords provided by The Hospital for Sick Children:
Hybrid
Norwood
congenital heart disease
single ventricle

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities