Pediatric Intensive Care and COVID-19

NCT ID: NCT04544878

Last Updated: 2020-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-26

Study Completion Date

2021-06-01

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.

Conditions

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Covid19 Pediatric ALL Infection Critical Illness SARS-CoV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pediatric patients

All term children from birth to 18 years of age admitted in the PICU

No interventions assigned to this group

Adult patients

All patients \>18 years of age

No interventions assigned to this group

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bicetre Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pierre Tissieres

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pierre Tissieres, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Bicêtre Hospital

Locations

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Pediatric Intensive Care and Neonatal Medicine, Bicêtre Hospital, AP-HP PAris Saclay University

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pierre Tissieres, MD, DSc

Role: CONTACT

+33145213205

Clemence Marais, MD, MSc

Role: CONTACT

+33145213205

Facility Contacts

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Clemence Marais, MD, MSc

Role: primary

+33145213205

Jordi Miatello, MD, MSc

Role: backup

+33145213205

Other Identifiers

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PS-PICRN--20001

Identifier Type: -

Identifier Source: org_study_id

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