Pediatric Intensive Care and COVID-19

• Conditions: Infection; SARS-CoV Infection; Covid19; Pediatric ALL; Critical Illness

• Registration Number: NCT04544878
• Lead Sponsor: Bicetre Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-26
• Status Verified: 2020-09
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University; 🇫🇷 Le Kremlin-Bicêtre, France