Clinical trial NCT03105414: INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children
Official title: Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia, Ventilator-Associated
Keywords: Mechanical ventilation
Pediatrics
Cross infection
Intensive care
Diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 2100
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Incidence of ventilator acquired pneumonia
timeFrame: Until weaning of ventilator or 1 year
Secondary outcomes:
measure: Bacteria prevalence of ventilator acquired pneumonia
timeFrame: Until weaning of ventilator or 1 year
measure: prevalence of diagnostic devices used to identify ventilator acquired pneumonia
timeFrame: Until weaning of ventilator or 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
References: