Background and purpose:
From the spring of 2020, an increasing number of children with a new clinical condition were reported from several countries, characterized by fever and severe inflammation that can affect several organs and where no infection or other underlying cause is detected.
Children have persistently high fever, high inflammatory parameters and the influence of one or more organs (eg low blood pressure / shock, influence on the heart, gastrointestinal symptoms, coagulation disorders, respiratory and neurological symptoms, etc.). Patients may have changes in the skin and mucous membranes and the condition may in some people resemble Kawasaki's disease (inflammation of blood vessels that can lead to dilation of coronary vessels). Patients have had an infection with SARS-CoV-2 2-6 weeks in advance and the condition is due to a strong immune response triggered by infection with the new coronavirus SARS-CoV-2. The condition has been given several names; Pediatric inflammatory Multisystem Syndrome temporally associated with sars-CoV-2 (PIMS-TS) and Multisystem inflammatory syndrome in children and adolescents temporally related to Covid-19 (MIS-C).
Because this is a completely new clinical condition, there is a great lack of knowledge about e.g. the spectrum of clinical manifestations, the clinical course, risk factors and the outcome of the disease, as well as the causes and not least how the disease should be treated.
In the UK, therefore, an initiative has been taken for an international collaboration where pediatric wards around the world are invited to systematically register clinical data, laboratory data and treatment of children with this condition in a common database.
The goal is to gain increased knowledge about all aspects of the condition, including the effects of various treatments given around the world.
All admitted patients aged 0-19 years who meet the inclusion criteria ("case definition") for PIMS-TS or MIS-C (see attached British protocol) or have Kawasaki disease are asked to participate. Participation in the study involves reporting of age, gender, ethnicity, clinical data and laboratory data from the hospital stay to a common database. Patients are assessed and treated in accordance with the best available knowledge and procedures at the ward in which they are admitted. It should not be taken additional tests, other assessment or intervention as a result of participation in the study.
Patients are asked to participate in connection with hospitalization. Patients who have previously been admitted with the condition are contacted afterwards by letter and / or telephone with a request to participate.
Unidentified data is registered in a common international study database administered by Imperial College London using the REDCap software application. The study does not involve the collection or storage of biological material.
The results of the analyzes of data from the international database are published together. In addition, each university has the opportunity to publish its own data, so that Norwegian data can be published separately.