Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease

NCT04814862 | Unknown

• 2 other identifiers: APHP210146IDRCB: 2020-A02841-38
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (1)

• 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).

  1 day

Secondary Outcomes (2)

• To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.

  1 day

• To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.

  1 day

Interventions

3 validated questionnaires (ADHD-RS, SRS, BRIEF) for the diagnosis of neurodevelopmental disorders BEHAVIORAL

Completion of three validated questionnaires for the diagnosis of neurodevelopmental disorders

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

All pediatric patients with systemic inflammatory disease

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Spermine Synthase

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Alkyl and Aryl Transferases; Transferases; Enzymes; Enzymes and Coenzymes

Study Officials

• Isabelle MELKI, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle MELKI, MD

CONTACT

+331 40 03 53 61; isabelle.melki@aphp.fr

Pierre ELLUL, MD

CONTACT

+331 40 03 41 31; pierre.ellul@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 24, 2021
• Study Start: December 6, 2021
• Primary Completion: December 6, 2022
• Study Completion: December 6, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share