Clinical trial NCT04814862: Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease
Official title: Descriptive and Risk Factor Analysis of Neuropsychiatric and Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurodevelopmental Disorders
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients with systemic inflammatory disease

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Insufficient comprehension of the French language
* Mental retardation with IQ \<30
* Not affiliated to a social security system

Primary outcomes:
measure: To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
timeFrame: 1 day
Secondary outcomes:
measure: To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
timeFrame: 1 day
measure: To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle MELKI, MD
role: PRINCIPAL_INVESTIGATOR
References: