Status:
COMPLETED
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Conditions:
Down Syndrome
Congenital Heart Disease
Eligibility:
All Genders
60-155 years
Brief Summary
The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children f...
Detailed Description
We are conducting a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes in children wi...
Eligibility Criteria
Inclusion
- Down Syndrome CAVSD Repair Group:
- Trisomy 21
- Male or Female, ages 5 years through 12 years
- Had CAVSD repair within the first year of life
- Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- Child able to speak and understand English
- Down Syndrome Comparison Group
- Trisomy 21
- Male or Female, age 5 years through 12 years
- No major CHD, defined as CHD requiring previous or planned CHD surgery
- Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
- Child able to speak and understand English
Exclusion
- Both Groups
- \- Mosaic DS
- Down Syndrome CAVSD Repair Group only - Did not have CAVSD repair in the first year of life
- Down Syndrome Comparison Group only
- \- Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned for a future date.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
273 Patients enrolled
Trial Details
Trial ID
NCT05312177
Start Date
May 1 2022
End Date
December 31 2023
Last Update
January 11 2024
Active Locations (14)
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1
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States, 19899
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
3
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30033
4
Riley Children's Hospital
Indianapolis, Indiana, United States, 46202