Pediatric Intensive Care and COVID-19

NCT04544878 | Unknown

• 1 other identifier: PS-PICRN--20001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Pediatric ALL; Infection; Critical Illness; SARS-CoV Infection

Keywords

Children; monitoring; immunodepression; HLA-DR; myeloid derived suppressor cell; neutrophil; phenotype

Outcome Measures

Primary Outcomes (1)

• Number of patient with secondary infection

  Secondary infection will include healthcare associated infections as well as sepsis, and septic shock

  2 weeks

Secondary Outcomes (3)

• Number of patients dying

  7-day, 28-day and 60-day

• Description of clinical phenotypes

  through study completion, an average of 4 weeks

• Description of immunological phenotypes

  through study completion, an average of 4 weeks

Study Arms (2)

Pediatric patients

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

Adult patients

All patients \>18 years of age

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patient or legal representative refusal to participate

Sponsors & Collaborators

• Bicetre Hospital: lead

Study Sites (1)

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

Le Kremlin-Bicêtre, 94275, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Infections; Critical Illness; Severe Acute Respiratory Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Tissieres, MD, DSc

  Bicêtre Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Tissieres, MD, DSc

CONTACT

+33145213205; pierre.tissieres@aphp.fr

Clemence Marais, MD, MSc

CONTACT

+33145213205; clemence.marais@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 16 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 10, 2020
• Study Start: March 26, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

FR (1)