Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Descriptive and Retrospective Analysis of Acute Myocarditis Associated With Pandemic COVID-19 in Children

Conditions
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COVID-19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 18 years Admitted to PICU from April 2020 Presented with an acute myocarditis, fever and shock with a possible COVID-19 infection Exclusion Criteria: Age ≥ 18 years Other etiologies of acute myocarditis than the COVID-19 Opposition expressed by the holders of parental authority

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Possible COVID-19 infection and acute myocarditis<br>Children presented with an acute myocarditis, fever and shock with a possible COVID-19 infection cared between April 2020 till the end of the main SARS-Cov-2 outbreak in 4 AP-HP Parisian hospitals : Necker-Enfants Malades Armand Trousseau Robert Debré Kremlin Bicêtre | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute myocarditis | Occurrence, description and time course of acute myocarditis | 7 days | 
| Multi-systemic inflammatory syndrome | Occurrence, description and time course of multi-systemic inflammatory syndrome, features of Kawasaki disease | 7 days | 
| Kawasaki disease | Occurrence, description and time course of features of Kawasaki disease | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Results of SARS-CoV-2 | Results of SARS-CoV-2 screening either by PCR or antibodies serological assay | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Acute myocarditis, Children