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NCT05312177 · ClinicalTrials.gov registry record
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
A clinical trial of Congenital Heart Disease and Down Syndrome, sponsored by Carelon Research.
- Completed
- Registry status
- 273
- Enrollment target
- 14
- Study locations
NCT05312177: Completed study of Congenital Heart Disease and Down Syndrome, sponsored by Carelon Research.
NCT05312177 is a study of Congenital Heart Disease and Down Syndrome that has completed, run by Carelon Research. The registered enrollment target is 273 participants, below the 470-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (42% lower). The trial reports 14 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05312177, a study of Congenital Heart Disease and Down Syndrome, has completed, sponsored by Carelon Research.
- COMPLETED
- Registry status
- 273 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
Verbal and non-verbal ratio intelligent quotients (IQs) derived from the Stanford Binet Intelligence Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Conditions Studied
Interventions
- OTHER Stanford Binet Intelligence Scales, Fifth Edition
- OTHER Vineland Adaptive Behavior Scales Third Edition
- OTHER Peabody Picture Vocabulary Test, Fifth Edition
- OTHER Expressive Vocabulary Test, Third Edition
- OTHER Leiter International Performance Scale, Third Edition
Study Locations (14)
Delaware
- Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Hospital - Washington D.C.
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2023-12-31 |
What the finished NCT05312177 record still lists
NCT05312177 is an observational study that tracks outcomes without assigning an intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 470-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (42% lower).
The record links to 2 conditions, with Congenital Heart Disease appearing as the primary indexed condition, and to 5 interventions - of which Stanford Binet Intelligence Scales, Fifth Edition is the first listed.
NCT05312177 lists 14 locations in 14 states (Delaware, District of Columbia, Georgia).
Frequently Asked Questions
What is clinical trial NCT05312177 about?
NCT05312177 is a clinical study titled "Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)". 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 ...
What is the current status of trial NCT05312177?
This trial is currently completed. The enrollment target is 273 participants. The study started on 2022-05-01. Estimated completion is 2023-12-31.
What conditions does trial NCT05312177 study?
This clinical trial studies the following conditions: Congenital Heart Disease, Down Syndrome.
What interventions are being tested in trial NCT05312177?
The interventions under investigation include: Stanford Binet Intelligence Scales, Fifth Edition (OTHER), Vineland Adaptive Behavior Scales Third Edition (OTHER), Peabody Picture Vocabulary Test, Fifth Edition (OTHER), Expressive Vocabulary Test, Third Edition (OTHER), Leiter International Performance Scale, Third Edition (OTHER).
Who is sponsoring clinical trial NCT05312177?
This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05312177 being conducted?
This trial has 14 study locations across Delaware, District of Columbia, Georgia, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05312177's enrollment target sits among peer trials
273 14th of 63 higher than 50 of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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