INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

• Conditions: Pneumonia, Ventilator-Associated

• Registration Number: NCT03105414
• Lead Sponsor: Sylvie Chevret

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-03
• Study First Submitted: 2017-04-04
• Study First Submitted QC: 2017-04-04
• Study First Posted: 2017-04-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09
• Primary Completion: 2018-05-15
• Study Completion: 2019-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of ventilator acquired pneumonia	Until weaning of ventilator or 1 year	CDC definition of ventilator acquired pneumonia

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debré Hospital; 🇫🇷 Paris, France