Down SyndromeCHILD-DSNCT05312177
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
An observational study of Down Syndrome and Congenital Heart Disease, run by Carelon Research at 14 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 60 to 155 monthsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome, Congenital Heart Disease
- What is being tested?
- Stanford Binet Intelligence Scales, Fifth Edition, Vineland Adaptive Behavior Scales Third Edition and Peabody Picture Vocabulary Test, Fifth Edition
- How many people
- 273 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 1 May 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 155 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: PHN RLS Study participants with DS and CAVSD repair from the PHN sites are eligible to participate in this study. Children with a diagnosis of mosaic DS will be excluded, as these forms of DS show different ND trajectories and are usually excluded. While data on mosaic DS were not collected in the RLS Study, we anticipate few if any to have this diagnosis. The DS comparison group will be required to have no major CHD, defined as CHD that requires CHD surgery (a) in the period between birth and recruitment into the CHILD-DS Study or (b) planned for a future date.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
United States13 sites
University of Michigan Health System/Mott Hospital
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30033
Boston Children's Hospital
Boston, Massachusetts, 02111
Medical University of South Carolina
Charleston, South Carolina, 29425
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, 77030
Riley Children's Hospital
Indianapolis, Indiana, 46202
Children's Mercy Hospital
Kansas City, Missouri, 64108
Columbia College of Physicians and Surgeons
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Primary Children's Hospital
Salt Lake City, Utah, 84132
Children's National Hospital
Washington D.C., District of Columbia, 20010
Alfred I. duPont Hospital for Children
Wilmington, Delaware, 19899
About this study
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.
Read the detailed 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).
- Conditions
- Down Syndrome, Congenital Heart Disease
- Being tested
- Stanford Binet Intelligence Scales, Fifth Edition, Vineland Adaptive Behavior Scales Third Edition, Peabody Picture Vocabulary Test, Fifth Edition, Expressive Vocabulary Test, Third Edition, Leiter International Performance Scale, Third Edition
- Keywords
- Down Syndrome, CHD, Congenital Heart Disease, Pediatric Heart Network, INCLUDE
- Medical subject headings
- Down Syndrome, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stanford Binet Intelligence Scales, Fifth EditionOther
Also called SB-5
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 EditionOther
Also called VABS-3
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 EditionOther
Also called PPVT-5
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 EditionOther
Also called EVT-3
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 EditionOther
Also called Leiter-3
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 FormOther
Also called SCQ
The SCQ is a parent-report measure of social communication, social interactions, play, and behavior.
Aberrant Behavior ChecklistOther
Also called ABC-2
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, RevisedOther
Also called RBS-R
The RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors.
| Study group | Role | What they receive |
|---|---|---|
| DS with CAVSD Repair | Children ages 5 through 12 years with Down syndrome who had Complete atrioventricular septal defect (CAVSD) repair in the first year of life and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R) Receives: 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; Other: Social Communication Questionnaire, Current Form; Other: Aberrant Behavior Checklist; Other: Repetitive Behavior Scale, Revised | |
| DS without major CHD | Children ages 5 through 12 years with Down syndrome without major Congenital Heart Disease(CHD) and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R) Receives: 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; Other: Social Communication Questionnaire, Current Form; Other: Aberrant Behavior Checklist; Other: Repetitive Behavior Scale, Revised |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Maria VanRompay, PhD, Principal investigator, Carelon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312177
- Sponsor's protocol ID
- CHILD-DS
- Other IDs
- 3U24HL135691-03S1
- Acronym
- CHILD-DS
- Status last verified
- Oct 2023
- First submitted
- 24 Feb 2020
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Public Use Datasets are created after study closeout and are made available on the PHN public website. Annotated study data collection forms, Statistical Analysis Program (SAS) datasets, and excel datasets are made available, as well as de-identified study cohort characteristics.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
- ClinicalTrials.gov ID
- NCT05312177
- Acronym / sponsor ID
- CHILD-DS / CHILD-DS
- Conditions
- Down Syndrome, Congenital Heart Disease
- Keywords
- Down Syndrome, CHD, Congenital Heart Disease, Pediatric Heart Network, INCLUDE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS with CAVSD Repair | – | 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, Other: Social Communication Questionnaire, Current Form, Other: Aberrant Behavior Checklist, Other: Repetitive Behavior Scale, RevisedChildren ages 5 through 12 years with Down syndrome who had Complete atrioventricular septal defect (CAVSD) repair in the first year of life and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R) |
| DS without major CHD | – | 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, Other: Social Communication Questionnaire, Current Form, Other: Aberrant Behavior Checklist, Other: Repetitive Behavior Scale, RevisedChildren ages 5 through 12 years with Down syndrome without major Congenital Heart Disease(CHD) and their parent(s) will be administered the Stanford-Binet Intelligence Scales, Fifth Edition (SB-5), Peabody Picture Vocabulary Test, Fifth Edition (PPVT-5), Expressive Vocabulary Test, Third Edition (EVT-3), Leiter International Performance Scale, Third Edition (Leiter-3), Vineland-3 Q-global Comprehensive Report (Vineland-3) ,Social Communication Questionnaire, Current version (SCQ), Aberrant Behavior Checklist, Second Edition, (ABC-2) and Repetitive Behavior Scale, Revised (RBS-R) |
Who may qualify
- Ages
- 60 to 155 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- PHN RLS Study participants with DS and CAVSD repair from the PHN sites are eligible to participate in this study. Children with a diagnosis of mosaic DS will be excluded, as these forms of DS show different ND trajectories and are usually excluded. While data on mosaic DS were not collected in the RLS Study, we anticipate few if any to have this diagnosis. The DS comparison group will be required to have no major CHD, defined as CHD that requires CHD surgery (a) in the period between birth and recruitment into the CHILD-DS Study or (b) planned for a future date.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stanford Binet Intelligence Scales, Fifth EditionAlso: SB-5The 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. | Other | DS with CAVSD Repair, DS without major CHD |
| Vineland Adaptive Behavior Scales Third EditionAlso: VABS-3The 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. | Other | DS with CAVSD Repair, DS without major CHD |
| Peabody Picture Vocabulary Test, Fifth EditionAlso: PPVT-5The 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. | Other | DS with CAVSD Repair, DS without major CHD |
| Expressive Vocabulary Test, Third EditionAlso: EVT-3The 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. | Other | DS with CAVSD Repair, DS without major CHD |
| Leiter International Performance Scale, Third EditionAlso: Leiter-3The 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). | Other | DS with CAVSD Repair, DS without major CHD |
| Social Communication Questionnaire, Current FormAlso: SCQThe SCQ is a parent-report measure of social communication, social interactions, play, and behavior. | Other | DS with CAVSD Repair, DS without major CHD |
| Aberrant Behavior ChecklistAlso: ABC-2The 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. | Other | DS with CAVSD Repair, DS without major CHD |
| Repetitive Behavior Scale, RevisedAlso: RBS-RThe RBS-R is a parent report measure that comprehensively surveys for the presence of repetitive behaviors. | Other | DS with CAVSD Repair, DS without major CHD |
Primary outcome
Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Time frame: 1 day
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.
Behavioral outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD.
Time frame: 1 day
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.
Language abilities compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Time frame: 1 day
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.
Emotional outcomes compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Time frame: 1 day
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.
Social Communication compared between the children with DS and CAVSD repair and the children with DS without major CHD.
Time frame: 1 day
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.
2 secondary outcomes
Comorbidities as predictors of neurodevelopment and behavior
Time frame: 1 day
Sociodemographic factors as predictors of neurodevelopment and behavior
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: Yes. Public Use Datasets are created after study closeout and are made available on the PHN public website. Annotated study data collection forms, Statistical Analysis Program (SAS) datasets, and excel datasets are made available, as well as de-identified study cohort characteristics.
Related trials for Down Syndrome
Not yet recruitingPhase 4
Oral Switch in Bloodstream Infections in Immunocompromised Children
Bloodstream Infection, Bloodstream Infection Due to Central Venous Catheter
Not yet recruiting
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
Aging, Healthy, Aging and Cognitive Health
Active, not recruitingPhase 3
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia
B Acute Lymphoblastic Leukemia, B Lymphoblastic Lymphoma
Not yet recruiting
Executive Function Play Opportunities for Children With Down Syndrome
Down Syndrome, Trisomy 21
RecruitingObservational study
Natural History of Dysregulation and Aging of the Immune System in People With Trisomy 21 With and Without Thymectomy
Down Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria VanRompay, PhD principal investigator
Carelon Research
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Down Syndrome and Congenital Heart Disease, run by Carelon Research at 14 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental outcomes between children with DS who had CAVSD repair and children from the same clinical sites with DS without major CHD. (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.