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INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03105414
Acronym
INCIPAVE
Enrollment
2100
Registered
2017-04-10
Start date
2017-04-03
Completion date
2019-05-15
Last updated
2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Ventilator-Associated

Keywords

Mechanical ventilation, Pediatrics, Cross infection, Intensive care, Diagnosis

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.

Interventions

DEVICEMechanical ventilation

Mechanical ventilation

Sponsors

Sylvie Chevret
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Incidence of ventilator acquired pneumoniaUntil weaning of ventilator or 1 yearCDC definition of ventilator acquired pneumonia

Secondary

MeasureTime frame
Bacteria prevalence of ventilator acquired pneumoniaUntil weaning of ventilator or 1 year
prevalence of diagnostic devices used to identify ventilator acquired pneumoniaUntil weaning of ventilator or 1 year

Countries

France

Contacts

Primary ContactStéphane Dauger, MD
stephane.dauger@aphp.fr140032000
Backup ContactMatthieu Resche-Rigon, MD
matthieu.resche-rigon@univ-paris-diderot.fr142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026