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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

Tracking Information
First Submitted Date  ICMJE March 23, 2010
First Posted Date  ICMJE May 31, 2010
Last Update Posted Date May 31, 2010
Study Start Date  ICMJE March 2010
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2010)
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Hybrid Versus Norwood Management Strategies in Infants Undergoing Single Ventricle Palliation
Official Title  ICMJE The Influence of Postoperative Systemic Oxygen Transport on Neurologic and Functional Outcomes in Infants Undergoing Single Ventricle Palliation With Norwood and Hybrid Management Strategies
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Congenital Heart Disease
Intervention  ICMJE
  • Procedure: Norwood management strategy
    Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
  • 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.

Study Arms
  • Active Comparator: Arm 1
    Hybrid Management
    Intervention: Procedure: Hybrid Strategy
  • Active Comparator: Arm 2
    Norwood Management
    Intervention: Procedure: Norwood management strategy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 27, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date March 2012
Estimated Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender
Sexes Eligible for Study: All
Ages up to 3 Months   (Child)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01134302
Other Study ID Numbers  ICMJE 1000013962
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Christopher Caldarone, Principal Investigator, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christopher Caldarone The Hospital for Sick Children, Toronto Canada
PRS Account The Hospital for Sick Children
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP