- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05077020
Somatic Diseases in Autistic Children (SDA)
October 18, 2021 updated by: University Hospital, Montpellier
Medical Monitoring and Somatic Diseases in Children Who Suffer From Autism Spectrum Disorder (ASD)
For many reasons, medical monitoring in autistic patients is very difficult.
This study is designed to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier.
Study Overview
Status
Completed
Conditions
Detailed Description
Mean goal : to determine the prevalence of comorbid diseases (neurological, cardiac, digestive, dental diseases…) in patients suffering from ASD to prevent them or diagnose them earlier.
Secondary goals :
- to obtain an objective assessment of the "general" monitoring in these patients (vaccinations, growth…)
- to assess their habits (food, sleep, screen exposition)
- to determine, in this monitoring and the habits, vigilance points which will need a specific pediatric consultation.
Study Type
Observational
Enrollment (Actual)
27
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Montpellier, France, 34295
- Uhmontpellier
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children followed by psychiatrists in Montpellier university hospital refered to a somatic pediatrician
Description
Inclusion criteria:
- consultation after psychiatric evaluation
Exclusion criteria:
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Determine the prevalence of comorbid diseases
Time Frame: 1 day
|
Determine the prevalence of comorbid diseases
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric JEZIORSKI, University Hospital, Montpellier
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
January 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
October 11, 2021
First Submitted That Met QC Criteria
October 11, 2021
First Posted (Actual)
October 13, 2021
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 18, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECHMPL21_0556
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
NC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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