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临床试验/NCT04379089
NCT04379089已完成不适用

Neurologic Manifestations of COVID 19 in Children

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 3,568 人开始时间: 2020年4月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,568
试验地点
1
主要终点
Child and family health functions

研究概览

简要总结

The purpose of this study is to perform a secondary analysis of pre-existing de-identified limited datasets obtained from sites participating in Tier 1 (STUDY20040154: Neurologic Manifestations of COVID 19 in Children) and Tier 2 (STUDY20040278: Neuro COVID - Outcomes). The data will be used to determine the prevalence and severity of neurological symptoms among patients requiring critical care admission for confirmed or suspected novel coronavirus (COVID-19) and to determine the predictors for limitation of care in the study population, as well as, the prognosis of neurologically injured patients admitted to the ICU during the COVID-19 crisis.

This study is sponsored by the Pediatric Neurocritical Care Research Group (PNCRG) and sponsored and funded in part by the Neurocritical Care Society.

详细描述

Early reports of COVID-19 indicate that adults experience a variety of neurological symptoms and diagnoses in approximately 36% of patients, including headaches, seizures, coma, encephalitis, and cerebrovascular events including ischemic stroke, intracranial hemorrhage, and cerebral venous sinus thromboses. In children, recent evidence highlights acute and long-term neurological manifestations due to other viral illnesses including Guillain Barre syndrome and neonatal microcephaly with Zika virus, encephalitis with H1N1 influenza, and acute flaccid paralysis with enterovirus-68. However, COVID-19 reports in children published thus far lack detailed information on the frequency and outcomes of neurological findings.

COVID-19 cases are rapidly rising internationally, with experts forecasting subsequent global surges and continued activity. Thus, it is imperative to accurately document prevalence and outcomes of the neurological aspects of COVID-19 specifically in children. Such data will serve to alert clinicians and families about the possibility that children may present with neurologic rather than "classic" symptoms of COVID-19 who nevertheless would warrant testing, and that neurologic events can occur subsequent to the diagnosis that may impact long-term outcomes (e.g., cognitive, emotional, physical health). The investigators anticipate that improved knowledge about neurologic manifestations in children will bolster personalized treatment and rehabilitation strategies to optimize child outcomes and inform future interventional studies.

研究设计

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

入排标准

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

入选标准

  • Infants, children, and young adults age < 18 years
  • Admitted to the hospital with confirmed or presumed COVID-19 infection (includes admissions to emergency, ward, intensive care etc.)

排除标准

  • 未提供

结局指标

主要结局

Child and family health functions

时间窗: 1 month post discharge

Measure child and family health functions and health-related quality of life (HRQOL) outcomes post discharge in children with confirmed or presumed COVID-19 and/or MISC diagnoses.

Prevalence

时间窗: 1 year

Determine the prevalence of neurological manifestations and association with outcome in children with confirmed or presumed COVID-19 and/or MISC hospitalized between January 2020 and December 2021.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ericka Fink

Associate Professor, Division of Pediatric Critical Care Medicine

University of Pittsburgh

研究点 (1)

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