Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04811456
Status:
UNKNOWN
Last Update Posted:
2021-03-26
First Post:
2021-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
MultiOrgan Inflammatory Syndromes COVID-19 Related Study
Sponsor:
Medical University of Warsaw
Organization:
Study Overview
Official Title:
MultiOrgan Inflammatory Syndromes COVID-19 Related Study
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOIS-CoR
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: