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COMPLETED

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

NCT05312177 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 273 participants
Start Date 2022-05-01
Est. Completion 2023-12-31

Sponsor

Carelon Research

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05312177

The ClinicalTrials.gov registry entry for NCT05312177 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carelon Research, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05312177 reports 14 study locations spanning 14 distinct geographic areas — top geographies include Delaware, District of Columbia, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05312177?

This trial is sponsored by Carelon Research, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial