Neurodevelopmental DisordersArtemisNCT04814862
Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease
An observational study of Neurodevelopmental Disorders, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Systemic inflammatory diseases in children include autoinflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- 3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disorders
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 6 Dec 2021to 6 Dec 2022
- 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 5 to 17 years
- All sexes
- Child
Study population: All pediatric patients with systemic inflammatory disease
Who may be able to join
- Any patient with a systemic inflammatory disease
- Age between 5 and 17 years old
- Parents informed and having signed a consent or having consented orally in case of absence of one of the two parents
Who cannot join
- Insufficient comprehension of the French language
- Mental retardation with IQ <30
- Not affiliated to a social security system
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Descriptive and Risk Factor Analysis of Neuropsychiatric and Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease
Systemic inflammatory diseases in children include autoinflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Neurological damage has been reported in both cases, but the neurodevelopmental psychiatric manifestations are poorly known, especially in children.
Neurodevelopmental disorders are a broad spectrum of pathologies that are underpinned by common symptomatic dimensions. They have a common physiopathology combining genetic predisposing factors as well as environmental risk factors, making it possible to study them from a global point of view. Among the environmental risk factors, the immune system seems to play an important role in the appearance of these pathologies.
In recent years, fundamental and animal studies have pointed to an important role of the immune system at the cerebral level. Indeed, far from the old notion of ""immune privilege"", the innate or adaptive immune balance seems to have a fundamental role in the proper development and functioning of the brain. Consequently, any modification of the immune balance could then disrupt neurodevelopment. Indeed, in recent years epidemiological studies seem to indicate the role of immune-mediated events during pregnancy (maternal autoimmune/inflammatory pathology or infection during pregnancy) or the first years of life (autoimmune/inflammatory pathology) as risk factors for neurodevelopmental disorders. Neurodevelopmental manifestations are very poorly known in systemic inflammatory pathologies. They can have a significant impact and justify adapted care in order to limit the functional impact. The main objective of our study will be to define the prevalence of neurodevelopmental disorders in children with systemic inflammatory diseases.
Read the detailed description
Systemic inflammatory diseases in children include auto-inflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Neurological damage has been reported in both cases, but the neurodevelopmental psychiatric manifestations are poorly known, especially in children. Neurodevelopmental disorders are a broad spectrum of pathologies with common symptomatic dimensions. They present a common physiopathology combining genetic predisposition factors as well as environmental risk factors, which allows them to be studied from a global perspective. Among the environmental risk factors, the immune system seems to play an important role in the appearance of these pathologies. In recent years, fundamental and animal studies have highlighted an important role of the immune system at the cerebral level. Indeed, far from the old notion of ""immune privilege"", the innate or adaptive immune balance seems to have a fundamental role in the proper development and functioning of the brain. Consequently, any change in the immune balance could then disrupt neurological development. Indeed, in recent years, epidemiological studies seem to indicate the role of immune-mediated events during pregnancy (maternal autoimmune/inflammatory pathology or infection during pregnancy) or the early years of life (autoimmune/inflammatory pathology) as risk factors for neurodevelopmental disorders.
Neurodevelopmental manifestations are very poorly known in systemic inflammatory pathologies. They can have a significant impact and justify adapted care in order to limit the functional impact. Indeed, due to their pathology, these patients produce pro-inflammatory cytokines at an early stage which could have an impact on their neurodevelopment. The identification of neurodevelopmental disorders in these patients could be a clinical and epidemiological validation of preclinical studies highlighting the importance of the immune system in the proper development of the brain. The main objective of our study will be to define the prevalence of neurodevelopmental disorders in children suffering from systemic inflammatory diseases via the passing on by parents of children between 5 and 17 years old of three hetero-questionnaires (i) SRS (assessing social interaction disorders), (ii) ADHD-RS (assessing attentional and hyperactivity difficulties) (iii) BRIEF (assessing difficulties in executive functions). All the results of these scales are adjusted for the age and sex of the patients and provide a T-score (allowing a valid comparison).
This is a multi-centre cross-sectional study involving the collection of data from patients' medical records and questionnaires from patients' parents.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- 3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disorders
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disordersBehavioural
Completion of three validated questionnaires for the diagnosis of neurodevelopmental disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Number of children scoring above 75th percentile on ADHD-RS out of all patients presenting a systemic inflammatory pathology.
All the results of these scales are adjusted for the age and sex of the patients (allowing a valid comparison).
Measured: 1 day
Secondary outcomes (2)
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Number of children scoring T-score above 60 on SRS out of all patients presenting a systemic inflammatory pathology.
All the results of this scale are adjusted for the age and sex of the patients (allowing a valid comparison).
Measured: 1 day
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Number of children scoring above 1SD on BRIEF out of all patients presenting a systemic inflammatory pathology.
All the results of this scale are adjusted for the age and sex of the patients (allowing a valid comparison).
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 posted24 Mar 2021
- Study start6 Dec 2021 (estimated)
- Primary completion6 Dec 2022 (estimated)
- Study completion6 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle MELKI, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814862
- Sponsor's protocol ID
- APHP210146
- Other IDs
- IDRCB: 2020-A02841-38
- Acronym
- Artemis
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive and Risk Factor Analysis of Neuropsychiatric and Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease
- ClinicalTrials.gov ID
- NCT04814862
- Acronym / sponsor ID
- Artemis / APHP210146
- Conditions
- Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 6 Dec 2021 (estimated)
- Primary completion
- 6 Dec 2022 (estimated)
- Study completion
- 6 Dec 2022 (estimated)
- First posted
- 24 Mar 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.
Systemic inflammatory diseases in children include autoinflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Neurological damage has been reported in both cases, but the neurodevelopmental psychiatric manifestations are poorly known, especially in children.
Neurodevelopmental disorders are a broad spectrum of pathologies that are underpinned by common symptomatic dimensions. They have a common physiopathology combining genetic predisposing factors as well as environmental risk factors, making it possible to study them from a global point of view. Among the environmental risk factors, the immune system seems to play an important role in the appearance of these pathologies.
In recent years, fundamental and animal studies have pointed to an important role of the immune system at the cerebral level. Indeed, far from the old notion of ""immune privilege"", the innate or adaptive immune balance seems to have a fundamental role in the proper development and functioning of the brain. Consequently, any modification of the immune balance could then disrupt neurodevelopment. Indeed, in recent years epidemiological studies seem to indicate the role of immune-mediated events during pregnancy (maternal autoimmune/inflammatory pathology or infection during pregnancy) or the first years of life (autoimmune/inflammatory pathology) as risk factors for neurodevelopmental disorders. Neurodevelopmental manifestations are very poorly known in systemic inflammatory pathologies. They can have a significant impact and justify adapted care in order to limit the functional impact. The main objective of our study will be to define the prevalence of neurodevelopmental disorders in children with systemic inflammatory diseases.
Detailed description
Systemic inflammatory diseases in children include auto-inflammatory diseases (deregulation of the innate immune system with production of pro-inflammatory cytokines) and autoimmune diseases (deregulation of the adaptive immune system with production of pathogenic autoantibodies). Neurological damage has been reported in both cases, but the neurodevelopmental psychiatric manifestations are poorly known, especially in children. Neurodevelopmental disorders are a broad spectrum of pathologies with common symptomatic dimensions. They present a common physiopathology combining genetic predisposition factors as well as environmental risk factors, which allows them to be studied from a global perspective. Among the environmental risk factors, the immune system seems to play an important role in the appearance of these pathologies. In recent years, fundamental and animal studies have highlighted an important role of the immune system at the cerebral level. Indeed, far from the old notion of ""immune privilege"", the innate or adaptive immune balance seems to have a fundamental role in the proper development and functioning of the brain. Consequently, any change in the immune balance could then disrupt neurological development. Indeed, in recent years, epidemiological studies seem to indicate the role of immune-mediated events during pregnancy (maternal autoimmune/inflammatory pathology or infection during pregnancy) or the early years of life (autoimmune/inflammatory pathology) as risk factors for neurodevelopmental disorders.
Neurodevelopmental manifestations are very poorly known in systemic inflammatory pathologies. They can have a significant impact and justify adapted care in order to limit the functional impact. Indeed, due to their pathology, these patients produce pro-inflammatory cytokines at an early stage which could have an impact on their neurodevelopment. The identification of neurodevelopmental disorders in these patients could be a clinical and epidemiological validation of preclinical studies highlighting the importance of the immune system in the proper development of the brain. The main objective of our study will be to define the prevalence of neurodevelopmental disorders in children suffering from systemic inflammatory diseases via the passing on by parents of children between 5 and 17 years old of three hetero-questionnaires (i) SRS (assessing social interaction disorders), (ii) ADHD-RS (assessing attentional and hyperactivity difficulties) (iii) BRIEF (assessing difficulties in executive functions). All the results of these scales are adjusted for the age and sex of the patients and provide a T-score (allowing a valid comparison).
This is a multi-centre cross-sectional study involving the collection of data from patients' medical records and questionnaires from patients' parents.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- All pediatric patients with systemic inflammatory disease
Key inclusion criteria (3 listed)
- Any patient with a systemic inflammatory disease
- Age between 5 and 17 years old
- Parents informed and having signed a consent or having consented orally in case of absence of one of the two parents
Key exclusion criteria (3 listed)
- Insufficient comprehension of the French language
- Mental retardation with IQ <30
- Not affiliated to a social security system
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 |
|---|---|---|
| 3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disordersCompletion of three validated questionnaires for the diagnosis of neurodevelopmental disorders | Behavioural | – |
Primary outcome
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Time frame: 1 day
Number of children scoring above 75th percentile on ADHD-RS out of all patients presenting a systemic inflammatory pathology. All the results of these scales are adjusted for the age and sex of the patients (allowing a valid comparison).
2 secondary outcomes
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Time frame: 1 day
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Isabelle MELKI, MD principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders, run by Assistance Publique - Hôpitaux de Paris.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle MELKI, MD (+331 40 03 53 61, isabelle.melki@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease. (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 18 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.