Autistic Spectrum DisorderSDANCT05077020
Somatic Diseases in Autistic Children
An observational study of Autistic Spectrum Disorder and Somatic Disorders, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Autistic Spectrum Disorder, Somatic Disorders
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2020to 1 Oct 2021
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children followed by psychiatrists in Montpellier university hospital refered to a somatic pediatrician
Who may be able to join
- consultation after psychiatric evaluation
Who cannot join
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autistic Spectrum Disorder, Somatic Disorders
- Medical subject headings
- Autism Spectrum Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the prevalence of comorbid diseases
Determine the prevalence of comorbid diseases
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 posted13 Oct 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic Spectrum DisorderStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JEZIORSKI, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077020
- Sponsor's protocol ID
- RECHMPL21_0556
- Acronym
- SDA
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Monitoring and Somatic Diseases in Children Who Suffer From Autism Spectrum Disorder (ASD)
- ClinicalTrials.gov ID
- NCT05077020
- Acronym / sponsor ID
- SDA / RECHMPL21_0556
- Conditions
- Autistic Spectrum Disorder, Somatic Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 13 Oct 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children followed by psychiatrists in Montpellier university hospital refered to a somatic pediatrician
Key inclusion criteria (1 listed)
- consultation after psychiatric evaluation
Key exclusion criteria (2 listed)
- age > 18 years
- Impossibility to obtain the consent of parents / legal representatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the prevalence of comorbid diseases
Time frame: 1 day
Determine the prevalence of comorbid diseases
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 26 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Eric JEZIORSKI study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Spectrum Disorder and Somatic Disorders, run by University Hospital, Montpellier at 1 site in France.
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 1 inclusion and 2 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 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Determine the prevalence of comorbid diseases (time frame: 1 day). 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 26 Oct 2021.