Pediatric Intensive Care and COVID-19

Study Overview
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Brief Summary
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In this prospective longitudinal cohort the investigators reported the clinical, and biological characteristics of all critically ill patients admitted in the pediatric intensive care unit (PICU) of Bicêtre Hospital during the 2019 coronavirus disease (COVID-19) pandemics. Patients were older than 37 weeks of gestational age. No upper limit was set as the unit was transiently converted into a pediatric adult COVID-19 intensive care unit.

Detailed Description
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All patients will be monitored during their PICU stay. Clinical characteristics include: age, gender, co-morbidities, organ support therapies (mechanical ventilation, renal replacement therapy, extracorporeal membrane oxygenation, vasopressors), organ complications (pulmonary embolism, acute respiratory distress syndrome, renal failure, heart failure) and function, infective complications (ventilator associated pneumonia, central line associated bloodstream infection, pulmonary access, sepsis, septic shock), microbiologic and viral identification, 7-day and 28-day mortality. Biological characteristics include: Admission workup: qualitative and quantitative Ig, ferritin, creatinine kinase, complement study (C3,C4,CH50), Daily workup: blood cells count, arterial blood gas analysis, lactate, electrolytes, albumin, blood urea nitrogen, creatinine, hemostasis (fibrinogen, factor V, II+VII, factor X, prothrombin time, antiXa activity, activated cephalin time, D-dimer), C-reactive protein, procalcitonin. Twice weekly workup: circulating cells phenotyping (T cell and subclass including Treg, B cell, Natural Killer cell, myeloid derived suppressor cell, neutrophils), interleukin 6. Bone marrow analysis when indicated by attending staff.

Official Title
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Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit

Conditions
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Covid19, Pediatric ALL, Infection, Critical Illness, SARS-CoV Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suspected or confirmed of severe acute respiratory syndrome Coronavirus 2 infection No opposition from patients or legal representatives after study information Patients admitted to the pediatric intensive care unit of Bicêtre Hospital, Assistance Publique Hôpitaux de Paris - Paris Saclay University Between March 15, 2020 to June 31, 2021 Exclusion Criteria: Patient or legal representative refusal to participate
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 |
| --- | --- |
| Pediatric patients<br>All term children from birth to 18 years of age admitted in the PICU | |
| Adult patients<br>All patients >18 years of age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient with secondary infection | Secondary infection will include healthcare associated infections as well as sepsis, and septic shock | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients dying | mortality | 7-day, 28-day and 60-day | 
| Description of clinical phenotypes | Description of the variable clinical phenotypes of COVID-19 in adults and children. This include COVID-19 respiratory failure, acute myocarditis and multi system inflammatory syndrome in children (MIS-C) | through study completion, an average of 4 weeks | 
| Description of immunological phenotypes | Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex | through study completion, an average of 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, monitoring, immunodepression, HLA-DR, myeloid derived suppressor cell, neutrophil, phenotype