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

Completed

Conditions studied: Down Syndrome, Congenital Heart Disease

In brief

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.

Key facts

Study ID

NCT05312177

Run by

Carelon Research

People needed

273

Starts

2022-05-01

Expected to finish

2023-12-31

Last updated by the study team

2024-01-11

Who can join

Age: 5 and older, up to 13. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Hospital — Washington D.C., District of Columbia, United States
• Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
• Riley Children's Hospital — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System/Mott Hospital — Ann Arbor, Michigan, United States
• Children's Mercy Hospital — Kansas City, Missouri, United States
• Columbia College of Physicians and Surgeons — New York, New York, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Baylor College of Medicine - Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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