Status:
COMPLETED
Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Heart Defects
Eligibility:
All Genders
12-24 years
Phase:
PHASE2
Brief Summary
The purpose of this project is to investigate the feasibility of using a home-based, parent-delivered model for providing neurodevelopmental rehabilitation programmes to infants who have had surgery f...
Detailed Description
Neurodevelopmental deficits are a common morbidity among children who receive surgical treatment for complex congenital heart defects in infancy. Over 40% of children with complex heart defects will h...
Eligibility Criteria
Inclusion
- Families will be eligible to participate in this study if the child:
- Had the arterial switch operation (for transposition of the great arteries) or has had a Glenn procedure (for functional single ventricle).
- Is medically stable for normal infant activities.
- Is between 12 and 24 months of age in January 2010.
Exclusion
- Families will be excluded from study participation if:
- The child has a recognized syndrome or other disability affecting neurodevelopment.
- The child has had a medical procedure in the 3 months preceding the baseline study assessment.
- The cardiologist responsible for the child's care refuses to allow the child's participation.
- The child performs substantially above age-appropriate developmental milestones during the initial assessment (in which case an intervention is unlikely to have a detectable additional benefit).
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01239784
Start Date
October 1 2009
End Date
June 1 2010
Last Update
August 27 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8