Clinical trial NCT04544878: Pediatric Intensive Care and COVID-19
Official title: Clinical and Biological Characteristics of Critically Ill Patients With COVID-19 Admitted to Pediatric Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Pediatric ALL
Infection
Critical Illness
SARS-CoV Infection
Keywords: Children
monitoring
immunodepression
HLA-DR
myeloid derived suppressor cell
neutrophil
phenotype
Lead sponsor: Bicetre Hospital
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Most patients admitted in the PICU of Bicêtre Hospital are children \<18 years old. Adults critically ill patients with COVID-19 were admitted in case of patients overflow in adult Intensive Care Unit.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patient with secondary infection
timeFrame: 2 weeks
Secondary outcomes:
measure: Number of patients dying
timeFrame: 7-day, 28-day and 60-day
measure: Description of clinical phenotypes
timeFrame: through study completion, an average of 4 weeks
measure: Description of immunological phenotypes
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University
Study officials:
affiliation: Bicêtre Hospital
name: Pierre Tissieres, MD, DSc
role: PRINCIPAL_INVESTIGATOR
References: