Clinical trial NCT04811456: MultiOrgan Inflammatory Syndromes COVID-19 Related Study
Official title: MultiOrgan Inflammatory Syndromes COVID-19 Related Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Keywords: MIS-C
PIMS-TS
COVID-19
hyperinflammation
children
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Wrocław Medical University
name: University of Warsaw
First posted: 2021-03-23
Enrollment: 1000
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 0-18 years old hospitalized with inflammatory conditions

Brief summary: The study comprise a nationwide, voluntary, on-line survey of inflammatory syndromes in children for retrospective (since 4th March 2020) and prospective data collection. Our aim was to capture and describe multisystem inflammatory syndrome in children (MIS-C) in Poland.

Detailed description: The voluntary surveillance for retrospective (since 4th March) and prospective data collection was initiated under the National Consultant of Pediatrics auspices. Anonymized patient data from pediatric hospitals from all over the country are extracted from electronic and paper records and collected through online form developed for that purpose. Before the surveillance was launched, reporting clinicians underwent an online training, which included the current state of knowledge about multisystem inflammatory syndrome in children (MIS-C). Patient management is at the discretion of the relevant treating clinicians.

KD and aKD were defined following the American Heart Association (AHA) guidelines.

TSS was established based on modified criteria by the Centers for Disease Control and Prevention.

MAS was diagnosed based on the Paediatric Rheumatology International Trials Organization (PRINTO) criteria for MAS classification.

The definition of the inflammatory syndrome was based on the WHO MIS-C definition with the exclusion of SARS-CoV-2 confirmation.

For patients who met the inclusion criteria, demographic data, past medical history, data on COVID-19 exposure, clinical symptoms, physical examination findings, laboratory, imaging, and cardiologic tests results, treatment, and outcome data are collected.

All study definitions are defined in accordance to relevant guidelines and evaluated automatically with the use of a dedicated software.

Eligibility criteria: Inclusion Criteria:

* patients who required hospitalization since 4th March 2020;
* diagnosed Kawasaki disease (KD) or incomplete (atypical) Kawasaki disease (aKD) or toxic shock syndrome (TSS) or macrophage activation syndrome (MAS) or unspecified inflammatory syndrome;

Exclusion Criteria:

* other infectious and non-infectious causes that could be responsible for the disease

SARS-CoV-2 polymerase chain reaction (PCR) or serology result could have been positive or negative. Due to limited availability and reliability of serologic testing, proven or likely COVID-19 criterion was not a condition determining inclusion to the registry.

Primary outcomes:
measure: PICU
timeFrame: 5 years
Secondary outcomes:
measure: Heart dysfunction
timeFrame: 5 years
measure: CAA
timeFrame: 5 years
measure: Hypotension
timeFrame: 5 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw Children's Hospital
city: Wrocław
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Medical University of Warsaw
name: Magdalena Okarska-Napierała
role: PRINCIPAL_INVESTIGATOR
References: