INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children (INCIPAVE)

Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant

Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.

Study Overview

• Status: Unknown
• Conditions: Pneumonia, Ventilator-Associated
• Intervention / Treatment: Device: Mechanical ventilation

• Study Type: Observational
• Enrollment (Anticipated): 2100

Contacts and Locations

• Study Contact: Name: Stéphane Dauger, MD; Phone Number: +33 140032000; Email: stephane.dauger@aphp.fr
• Study Contact Backup: Name: Matthieu Resche-Rigon, MD; Phone Number: +33 142499742; Email: matthieu.resche-rigon@univ-paris-diderot.fr

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Robert Debre Hospital
    • Contact: Stéphane Dauger, MD; Phone Number: +33 1 40 03 21 87; Email: stephane.dauger@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients admitted to Pediatric Intensive Care Unit aged more than 28 days and < 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet.

Description

Inclusion Criteria:

• Admitted to Pediatric Intensive Care Unit
• Aged more than 28 days and < 18 years
• Mechanically ventilated either by endotracheal or tracheostomy tube

Exclusion Criteria:

-

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of ventilator acquired pneumonia	CDC definition of ventilator acquired pneumonia	Until weaning of ventilator or 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Bacteria prevalence of ventilator acquired pneumonia	Until weaning of ventilator or 1 year
prevalence of diagnostic devices used to identify ventilator acquired pneumonia	Until weaning of ventilator or 1 year

Collaborators and Investigators

• Sponsor: Sylvie Chevret

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Anticipated): May 15, 2018
• Study Completion (Anticipated): May 15, 2019

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Pediatrics; Diagnosis; Mechanical ventilation; Intensive care; Cross infection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 11-362

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No