INCIPAVE Study: Incidence of Ventilator Acquired Pneumonia in Children

NCT03105414 | Unknown

• 1 other identifier: 11-362
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Ventilator-Associated

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator acquired pneumonia

  CDC definition of ventilator acquired pneumonia

  Until weaning of ventilator or 1 year

Secondary Outcomes (2)

• 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

Interventions

Mechanical ventilation DEVICE

Mechanical ventilation

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Sylvie Chevret: lead

Study Sites (1)

Robert Debré Hospital

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Cross Infection; Disease

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

Stéphane Dauger, MD

CONTACT

140032000; stephane.dauger@aphp.fr

Matthieu Resche-Rigon, MD

CONTACT

142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: April 3, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2019
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

FR (1)