Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

The Hospital for Sick Children

Status and phase: Completed; Phase 2

Conditions: Heart Defects

Treatments: Behavioral: Home-based neurodevelopmental rehabilitation programme

Study type: Interventional

Funder types: Other

Identifiers

NCT01239784

1000014278

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

All Subjects

Experimental group

Description:

A total of 20 children and their parents will be recruited for this study. Ten children will have had the Glenn procedure and 10 infants will have had the arterial switch operation.

Treatment:

Behavioral: Home-based neurodevelopmental rehabilitation programme