Clinical trial NCT01239784: Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
Official title: Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Defects
Keywords: pediatrics
Heart Defects
Neurodevelopmental deficit
Neurodevelopmental Rehabilitation
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 for a complex heart defect.

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 have neurodevelopmental deficits that persist throughout childhood even after a successful surgical procedure in infancy1. These deficits are typically related to basic motor perceptual motor or visual motor skills. Problems integrating what is seen (visual perceptions) with body movement (motor skills) makes it difficult for children to participate in peer play and limits their ability to succeed in school, thereby having a significant impact on the child's quality of life.

Traditional, therapist-delivered rehabilitation programmes to address these delays in neurodevelopment have not previously been attempted. It would be difficult to provide direct rehabilitation programmes to these patients given that their defects are rare and few patients are located within the same geographical area. Home-based, parent-delivered rehabilitation programmes have previously been shown to be effective at improving the motor skills of school-age children with complex heart defects5. Since a home-based parent delivered model would enable the participation of infants regardless of geographic location, the feasibility of using such a model for delivering neurodevelopmental rehabilitation should be investigated.

Eligibility criteria: Inclusion Criteria:

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 Criteria:

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).

Primary outcomes:
measure: Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales
timeFrame: Baseline and four months
Secondary outcomes:
measure: Parents opinion on the home-based neurodevelopmental rehabilitation programme
timeFrame: at 4 months
measure: Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme
timeFrame: at 4 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Brian McCrindle, MD
role: PRINCIPAL_INVESTIGATOR
References: