Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children
- Conditions
- COVID-19
- Registration Number
- NCT04420468
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.
- Detailed Description
An unexpected increase of shock with fever in children suspected to be infect by the COVID-19 is observed. These children present with similar symptoms and seem to have similar clinical time course.
This unexpected phenomenon needs to be extensively described in order to further the knowledge of unusual COVID-19 presentation in children.
The study consists an extensive retrospective data collection from April 2020 till the end of the main SARS-Cov-2 outbreak, from medical file of children have exhibited acute myocarditis and cared in 4 pediatric intensive care units of Assistance Publique-Hôpitaux de Paris of Ile-de-France region.
The study objectives are to descript clinical, biological and echocardiographic features of an acute myocarditis in children in the context of COVID-19 and to identify the underlying mechanism : direct viral damage and/or inadequate host response risk.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Age < 18 years
- Admitted to PICU from April 2020
- Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection
- Age ≥ 18 years
- Other etiologies of acute myocarditis than the COVID-19
- Opposition expressed by the holders of parental authority
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute myocarditis 7 days Occurrence, description and time course of acute myocarditis
Multi-systemic inflammatory syndrome 7 days Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease
Kawasaki disease 7 days Occurrence, description and time course of features of Kawasaki disease
- Secondary Outcome Measures
Name Time Method Results of SARS-CoV-2 7 days Results of SARS-CoV-2 screening either by PCR or antibodies serological assay
Trial Locations
- Locations (4)
Hôpital Necker-Enfants Malades
🇫🇷Paris, France
Hôpital Armand Trousseau
🇫🇷Paris, France
Hôpital Bicêtre
🇫🇷Le Kremlin-Bicêtre, France
Hôpital Robert Debré
🇫🇷Paris, France