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临床试验/NCT04814862
NCT04814862Unknown不适用

Descriptive and Risk Factor Analysis of Neuropsychiatric and Neurodevelopmental Disorders in Children With Systemic Inflammatory Disease

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 500 人开始时间: 2021年12月6日最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
主要终点
To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 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).

次要结局

  • To define the prevalence of neurodevelopmental disorders in children with systemic inflammatory disease.(1 day)

研究者

申办方类型
Other
责任方
Sponsor

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