Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)

Status: Completed
Location: See all (14) locations...
Intervention Type: Other
Study Type: Observational
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 from the same clinical sites with DS without major congenital heart disease (CHD) requiring previous or planned CHD surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 12
Healthy Volunteers: t
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⁃ 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

Locations
United States
Washington, D.c.
Children's National Hospital
Washington
Delaware
Alfred I. duPont Hospital for Children
Wilmington
Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta
Indiana
Riley Children's Hospital
Indianapolis
Massachusetts
Boston Children's Hospital
Boston
Michigan
University of Michigan Health System/Mott Hospital
Ann Arbor
Missouri
Children's Mercy Hospital
Kansas City
New York
Columbia College of Physicians and Surgeons
New York
Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
Philadelphia
South Carolina
Medical University of South Carolina
Charleston
Texas
Baylor College of Medicine - Texas Children's Hospital
Houston
Utah
Primary Children's Hospital
Salt Lake City
Other Locations
Canada
Hospital for Sick Children
Toronto
Time Frame
Start Date: 2022-05-01
Completion Date: 2023-12-31
Participants
Target number of participants: 273
Treatments
DS with CAVSD Repair
Children ages 5 through 12 years with Down syndrome who had Complete atrioventricular septal defect (CAVSD) repair in the first year of life and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)
DS without major CHD
Children ages 5 through 12 years with Down syndrome without major Congenital Heart Disease(CHD) and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R)
Sponsors
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
Leads: Carelon Research

This content was sourced from clinicaltrials.gov