Neurodevelopmental Rehabilitation for Toddlers With Complex Heart Defects

NCT01239784 | Completed Phase 2

• 1 other identifier: 1000014278
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Defects

Keywords

pediatrics; Heart Defects; Neurodevelopmental deficit; Neurodevelopmental Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in child's neurodevelopmental status at four months using the Peabody Development Motor Scales

  The Peabody Development Motor Scale has demonstrated validity and reliability for children from birth to 5 years of age. Six subtests (reflexes, stationary, locomotion, object manipulation, grasping, visual-motor integration) yield gross, fine and total motor quotient scores.

  Baseline and four months

Secondary Outcomes (2)

• Parents opinion on the home-based neurodevelopmental rehabilitation programme

  at 4 months

• Research students experience and perception of guiding a home-based, parent-delivered rehabilitation programme

  at 4 months

Study Arms (1)

All Subjects

EXPERIMENTAL

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.

Behavioral: Home-based neurodevelopmental rehabilitation programme

Interventions

Home-based neurodevelopmental rehabilitation programme BEHAVIORAL

Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period. The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.

All Subjects

Eligibility Criteria

• Age: 12 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

• Brian McCrindle, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 11, 2010
• Study Start: October 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

CA (1)