跳至主要内容
临床试验/NCT04909411
NCT04909411已完成不适用

Consequences of a Maternal-fetal Chikungunya Virus Infection. Neurocognitive and Sensory Assessment Around the Age of 13.

Centre Hospitalier Universitaire de la Réunion2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
2
主要终点
Total intelligence quotient

研究概览

简要总结

Chikungunya is an infectious disease caused by an alphavirus transmitted by the Aedes mosquitoes which has known a worldwide expansion since its re-emergence in 2004. Regarding to an unprecedented epidemic, Reunionese pediatricians described in 2005-2006 a vertical maternal-fetal transmission of this virus, at the time of childbirth. Since then, this mode of transmission has been widely confirmed, with an absolute risk estimated between 15.5% and 48.3%. The main consequences for the child are neuromotor, neurosensory or neurocognitive. They were studied around the age of 2 in 33 children in the CHIMERE cohort, as well as at the age of 5 in a small fraction of these children followed at the C.A.M.S.P (Center for Early Medico-Social Action). The results suggested an overall delay in psychomotor acquisitions secondary to neonatal infection, affecting the functions of the prefrontal region (in particular coordination and language). Performance was correlated with the severity of the clinical presentation (more severe in case of encephalitis or encephalopathy) while remaining suboptimal in children with uncomplicated infection. During neurodevelopmental monitoring, other disturbing traits complemented the spectrum of problems presented by these children, such as microcephaly, cerebral palsy, epilepsy, interaction disorder or attention deficit disorder. At around age 10, the investigators reassessed 21 of these children using the Childhood Cognitive Function and Learning (EDA) screening test. The investigators would now like to confirm and characterize their impairments using a battery of confirmatory tests around the age of 13.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
10 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Child born between March 2005 and July 2006
  • Of which the mother identified in the CHIMERE cohort or the perinatal register of maternities
  • Exposed: child infected with the chikungunya virus at the time of childbirth
  • Not exposed: child not infected with the chikungunya virus at the time of childbirth, verifying the matching criteria specified in chapter 5.2
  • Affiliated to a social insurance

排除标准

  • Prematurity <33 weeks
  • Prenatal alcoholization authenticated by fetal alcohol syndrome
  • Intellectual disability or secondary epilepsy of origin other than CHIKV infection (caused by ACSOS or any other cause of brain damage of inflammatory, metabolic or infectious origin)

结局指标

主要结局

Total intelligence quotient

时间窗: Month 3 (+/- 1 month)

Evaluation of total intelligence quotient with Wechsler Intelligence Scale for Children-5

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (2)

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