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

Congenital Heart Disease Clinical Trial

— CHILD-DS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05312177
• Other study ID #: CHILD-DS
• Secondary ID: 3U24HL135691-03S
• Status: Completed
• Start date: May 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2023
• Source: Carelon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

We are conducting a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes in children with DS, focusing on the role of CHD surgery. We are including children with DS who had CAVSD repair, as this group comprises 91% of all children with DS in the RLS Study, with similar underlying congenital cardiac defect and surgical repair complexity, allowing our children with DS and CHD to be a homogeneous group. Moreover, one in five individuals with DS is born with an AVSD, a 2000 times higher incidence than in those with normal chromosomes. In addition to recruiting children with DS who had CAVSD repair, we will recruit similarly-aged children with DS who do not have documented major CHD (i.e., CHD requiring previous or planned CHD surgery) to come into the same PHN site for a single study visit consisting of detailed phenotyping by completion of a Health & Developmental History Intake form, ND and behavioral assessments, and optional collection and storage of saliva specimens in the PHN Biorepository. By building our sample from RLS Study participants and recruiting additional children who had infant CAVSD repair and meet study eligibility criteria, as well as a comparison group from the same PHN sites, we are leveraging rich prospective data in a group of DS children with CAVSD repair from a nationally representative sample, and the expertise of the PHN and Boston Children's Hospital (BCH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 273
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Months to 155 Months

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Down Syndrome
• Heart Defects, Congenital
• Heart Diseases
• Syndrome

Intervention

Other:
• Stanford Binet Intelligence Scales, Fifth Edition
The SB-5 is a comprehensive measure of cognitive and intellectual functioning for individuals from age two through 85 years of age. The SB-5 individually assess a child's functioning in five areas of cognitive functioning: Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual Spatial, and Working Memory. The SB-5 is well established in the existing research literature as an assessment tool to evaluate developmental and intellectual abilities in children with ND disorders.
• Vineland Adaptive Behavior Scales Third Edition
The VABS-3 are a parent report, interview style measure of adaptive behavior for individuals ages birth through 90 months. The VABS-3 assesses adaptive behavior in four broad domains of Communication, Daily Living Skills, Socialization, and Motor Skills, and includes a Maladaptive Behavior Domain that assesses problem behaviors.
• Peabody Picture Vocabulary Test, Fifth Edition
The PPVT-5 is a norm-referenced language measure that evaluates single-word receptive vocabulary. The PPVT-5 provides standard scores for individuals ages 2.6 through 90 years.
• Expressive Vocabulary Test, Third Edition
The EVT-3 is a norm-referenced language measure that evaluates single-word expressive vocabulary. The EVT-3 provides standard scores for individuals ages 2.6 through 90 years.
• Leiter International Performance Scale, Third Edition
The Leiter-3 is a nonverbal measure of cognitive functioning and fluid reasoning skills in individuals ages 3 through 75 years. The Leiter-3 measures nonverbal IQ across four subscales, including Sequential Order (SO), Form Completion (FC), Classification and Analogies (CA), and Figure Ground (FG).
• Social Communication Questionnaire, Current Form
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
• Aberrant Behavior Checklist
The ABC-2 is a parent report measure of problematic behavior at home and in the community. It measures behavior on five subscales (1) Irritability, (2) Social Withdrawal, (3) Stereotypic Behavior, (4) Hyperactivity/Noncompliance, and (5) Inappropriate Speech.
• Repetitive Behavior Scale, Revised
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Carelon Research	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.	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.	1 day
Primary	Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.	Adaptive composite scores from the Vineland Adaptive Behavior Scales will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day
Primary	Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.	Using the Peabody Picture Vocabulary Test, Expressive Vocabulary Test, and Leiter International Performance Scale total language, auditory comprehension, and expressive communication will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day
Primary	Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.	Using the Repetitive Behavior Scale and Aberrant Behavior Checklist , behavioral and emotional problems will be compared will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day
Primary	Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.	Using the Social Communication Questionnaire, social communication, social interactions, play and behavior will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day
Secondary	Comorbidities as predictors of neurodevelopment and behavior	Comorbidities will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day
Secondary	Sociodemographic factors as predictors of neurodevelopment and behavior	Sociodemographic factors, such as will be compared between the children with DS and CAVSD repair and the children with DS without major CHD.	1 day