Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS) (NCT05312177) | Clinical Trial Compass
CompletedNot Applicable
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
United States, Canada273 participantsStarted 2022-05-01
Plain-language 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.
Who can participate
Age range
60 Months – 155 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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 Criteria:
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My child has Down syndrome and had CAVSD repair surgery — this study compared kids like them to kids with Down syndrome who didn't have major heart defects, so what do the findings tell us about whether heart surgery may have affected my child's neurodevelopment, language, or social communication?
2Since this study is now completed, has my doctor seen or read any of the published results, and what do those findings mean for how we should approach my child's developmental monitoring and support going forward?
3The study measured behavioral and emotional outcomes in addition to cognitive ones — based on what was found, are there specific behavioral or emotional challenges we should be watching for in my child that might be linked to having had congenital heart disease?
4Because this was an observational study comparing two groups rather than testing a new treatment, does it change or confirm anything about the therapies or early interventions my doctor would recommend for my child right now?
5Given that this research focused on kids with Down syndrome and CAVSD specifically, are there local developmental specialists or programs my doctor could refer us to who are familiar with this particular combination and the learning challenges it can bring?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Timeframe: 1 day
2
Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Timeframe: 1 day
3
Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Timeframe: 1 day
4
Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Timeframe: 1 day
5
Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.