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临床试验/NCT05137535
NCT05137535Unknown不适用

A Study of the Infection and Transmission of SARS-CoV-2 in Paediatric Patients

University of Padova1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年11月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Natural history

研究概览

简要总结

Covid-19 disease, originated by SARS-Cov-2 Coronavirus, officially appeared in Italy in February 2020. Children and adolescents, in most cases, have an asymptomatic or paucisymptomatic clinical picture and are very rarely hospitalized. Precisely because of the modest symptoms presented, information on the natural history of Covid19 disease and its symptomatology is still limited.

Because almost all children with Covid19 are treated by community medicine, family pediatricians are the most suitable figures to collect the clinical history of these patients.

Information regarding the mode of infection and spread at both the intrafamily and school levels is also poor, and the role that the opening of schools may have on the spread of infection is not yet well established. However, scientific evidence supports the adverse effect of school closures on the physical and mental health of children and adolescents.

Analysis of school spread in a specific area can therefore contribute to increased knowledge about the role of schools, and such information may be useful in guiding health policy choices.

详细描述

Covid-19 disease, caused by the coronavirus Sars-Cov-2, officially appeared in Italy in February 2020. As of January 2020, the first pediatric cases had already been described, initially in China and then in other countries. Clinical studies suggest that children are susceptible at any age and can transmit the SARS-CoV-2 virus; for the most part pediatric studies analyzed hospitalized patients.

Mainly children and young people present asymptomatic or paucisymptomatic symptoms, and very rarely require hospitalization: the biological reasons for this different clinical picture compared to the adult population are not clear. Just because of the modest symptomatology presented in pediatric age, the natural history of Covid-19 disease and its clinical features in pediatric age are not well known and the disease may be underdiagnosed. Equally scarce is information about Covid-19 spread both within the family and in school communities. These data depend on the availability of tests for the identification of Sars-CoV-2 infection and on how population screenings are organized.

However, knowledge about clinical aspects and diffusion of Covid-19 within the family and at school are fundamental to orient health policy choices such as the opening of schools and of social, educational and sports spaces for children and young people. It is known that transmission of SARS-CoV-2 can occur in school settings, but there are still no definitive data on the impact that this transmission may have on the spread of the infection within the population, because school closures always coincide with closures of other activities and often with general restrictions on the movement of people. Several studies suggest that transmission of SARS-CoV-2 at school is not frequent. School contributes a modest number to the total number of cases and in many cases the infection is attributable to the school staff. Also, the presence of multiple cases in the same school may depend on a greater spread of the virus in the community.

Scientific evidence confirms adverse effect of school closures on the physical and mental health of children and young people, with a very high cost considering impact on learning and reduction of skills in the long term: any reduction in school hours has negative effects on students' cognitive abilities, on the probability of dropping out of school, on college enrollment, and on employment outcomes. In addition, distance learning has exacerbated inequality, because access to computers and the internet is much more complicated for lower class families. Moreover, in some contexts, school closure has generated increases in domestic violence and situations of toxic prolonged stress for children.

The network of community medicine, formed by family pediatricians, represents a unique resource to study Covid-19 natural history in children and spread of disease in their family and at school within a specific territory.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Retrospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Natural history

时间窗: Feb. 1, 2020 - Dec. 31, 2021

Description of the natural history of Covid19 in paediatric patients in terms of length, severity and symptoms

Infection and spread

时间窗: Feb. 1, 2020 - Dec. 31, 2021

Description of the mode of infection and spread at both the intrafamily and school levels using suitable statistical models

次要结局

  • Monitoring(Feb. 1, 2020 - Dec. 31, 2021)
  • School opening(Feb. 1, 2020 - Dec. 31, 2021)

研究者

发起方
University of Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

BRAZZALE ALESSANDRA ROSALBA

Professor

University of Padova

研究点 (1)

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