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临床试验/NCT04786353
NCT04786353进行中(未招募)不适用

Long COVID Kids DK - Investigating Long-term Hospitalizations, GP Visits, Co-morbidities, Drug Prescriptions and Symptoms in Danish Children With Covid-19

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 330,000 人开始时间: 2021年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
330,000
试验地点
1
主要终点
Long COVID symptoms

研究概览

简要总结

During the COVID-19 pandemic children have been perceived as a group not being especially affected, with less being infected, low symptom burden and low mortality. A small proportion however develop life-threatening hyperinflammation (mis-c) and at least one Danish child has died from this condition. Since the fall of 2020 international awareness has been raised by parents reporting that their children experience gastrointestinal issues, chest pain, headaches, fatigue, joint/muscle pain, sore throat, dizziness, nausea and fever for months following COVID-19 infection.

In this study the investigators aim to investigate the proportions of possible long covid in the 45.000 Danish children that has been tested positive for covid-19. The investigators know from the Danish Covid-19 surveillance data that 300 has been admitted to the hospital within the first 2 weeks after diagnosing. However, no knowledge about how many visits the participants have to the ER and GP compared to children without covid-19 as well as hospital admissions within the first year and medical prescriptions within the first year. This knowledge can give the investigators an indication of how affected these children are on the long term. Furthermore, data has been collected about the long-term symptoms in adults, but not children, and it now seems obvious that this data are needed to fully understand the disease and orchestra the relevant medical attention for children during the covid-19 pandemic.

详细描述

Objectives

WP 1 Objective: to investigate long COVID symptoms after 3,6,9 and 12 months in children tested positive for SARS-CoV-2 compared to children without a positive test.

WP 2 Objective: to describe whether there is a difference in the number of visits to general practitioner, emergency department and hospitalizations in children with and without SARS-CoV-2. In addition, which co-morbid diagnoses are given 3,6,9 and 12 months after diagnosis with COVID and which drugs are prescribed.

Methods

Design: National register study and questionnaire survey.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • must be included in the covid-19 monitoring database

排除标准

  • 未提供

结局指标

主要结局

Long COVID symptoms

时间窗: Up to 1 year after diagnosis with covid-19

Through self-reported (by child or parent) survey data long COVID symptoms will be evaluated among children with and without COVID-19

Hospitalizations

时间窗: Up to 1 year after diagnosis with covid-19

To determine the number of hospitalizations in children with and without COVID-19, an identification from the Danish COVID-19 database linked with the Danish National Patient Register will occur.

Contacts to the general practitioner

时间窗: Up to 1 year after diagnosis with covid-19

To determine the difference in number of contacts to the general practitioner, in children with and without COVID-19, an identification from the Danish COVID-19 database linked with the Danish Health Insurrance Register will occur.

Diagnoses

时间窗: Up to 1 year after diagnosis with covid-19

To determine which diagnoses the children with covid-19 are given compared to children without covid-19, an identification from the Danish COVID-19 database linked with the Danish National Patient Register will occur.

Prescribed drugs

时间窗: Up to 1 year after diagnosis with covid-19

To determine which drugs the children with COVID-19 are given compared to children without covid-19, an identification from the Danish COVID-19 database linked with the Danish Medicines Registry will occur.

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

Selina Kikkenborg Berg

Professor

Rigshospitalet, Denmark

研究点 (1)

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