Pediatric Intensive Care and COVID-19

Overview

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.

Full Title of Study: “Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 1, 2021

Detailed Description

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.

Arms, Groups and Cohorts

  • Pediatric patients
    • All term children from birth to 18 years of age admitted in the PICU
  • Adult patients
    • All patients >18 years of age

Clinical Trial Outcome Measures

Primary Measures

  • Number of patient with secondary infection
    • Time Frame: 2 weeks
    • Secondary infection will include healthcare associated infections as well as sepsis, and septic shock

Secondary Measures

  • Number of patients dying
    • Time Frame: 7-day, 28-day and 60-day
    • mortality
  • Description of clinical phenotypes
    • Time Frame: through study completion, an average of 4 weeks
    • 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)
  • Description of immunological phenotypes
    • Time Frame: through study completion, an average of 4 weeks
    • Measure circulating cell phenotypes (relative percentage and monocyte classII histocompatibility complex

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bicetre Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pierre Tissieres, Professor – Bicetre Hospital
  • Overall Official(s)
    • Pierre Tissieres, MD, DSc, Principal Investigator, Bicêtre Hospital
  • Overall Contact(s)
    • Pierre Tissieres, MD, DSc, +33145213205, pierre.tissieres@aphp.fr

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