CClinicalTrials.gg
Status unknownNCT03763695Updated Dec 4, 2018

Effectiveness of a VAP Prevention Bundle in the PICU

An observational study in Ventilator Associated Pneumonia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-12-04.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
242
Ages
Up to 18 Years
Sex
All
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Study summary

This observational monocentric prospective study aims to evaluate the efficacy of new measures for ventilator associated pneumonia (VAP) management in the pediatric population in the pediatric intensive care unit (PICU) of Fondazione Policlinico Agostino Gemelli of 8 beds. The investigators will compare the incidence of VAP in the group of patients in which this protocol has been implemented to a retrospective control group of patients before the new protocol implementation. VAP bundle includes oral care hygiene measures (i.e chlorhexidine swab), to keep clean and dry ventilator circuits and head positioning at 45 degrees.

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Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • Pediatric intensive care unit
  • Oral Hygiene Care
  • Chlorhexidine
  • Broncho-alveolar lavage
  • Pharyngeal swab
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's planned enrollment of 242 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatric patients admitted to our ICU requiring mechanical ventilation for more than 48 hours

Inclusion criteria

  • age \< 18 years
  • patients receiving mechanical ventilation for more than 48 hours

Exclusion criteria

Exclusion Criteria:

  • no informed consent
  • pregnancy
  • previous endotracheal antibiotic therapy
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
242 participants (estimated)
Patient registry
No

Groups and cohorts

  • Retrospective control group

    Patients admitted in our PICU before the implementation of the protocol for VAP prevention (from 01/01/2016 to 12/31/2017)

    Other: Evaluation of VAP incidence before the protocol introduction

  • Prospective group

    Patients admitted to our PICU since the VAP bundle has been introduced in the clinical practice (from 01/01/2018)

    Other: Measures for the VAP prevention in the PICU

Interventions

  • OtherMeasures for the VAP prevention in the PICU

    Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.

  • OtherEvaluation of VAP incidence before the protocol introduction

    evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention

06

What researchers measure

Primary outcomes

  1. VAP incidence

    Incidence of VAP in pediatric patients intubated for more than 48 hours

    Time frame: From 48 hours after intubation to 48 hours after extubation

Secondary outcomes

  1. Prevalence of orotracheal bacterial colonization in ventilated patients

    Evaluation of orotracheal bacterial colonization in pediatric patients undergoing mechanical ventilation twice a week

    Time frame: From 48 hours after intubation to 48 hours after extubation

07

Study locations

1 of 1 sites recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli
    Roma, RM 00168, Italy
    • Orazio Genovese, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03763695
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborators
Ilaria Vitali, Antonio Maria Dell Anna, Leonardo Dassatti, Giuseppe Bello, Giorgio Conti, Antonio D Addona
Responsible party
Orazio Genovese (Medical Doctor, pediatric intensive care unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Dec 4, 2018
Start date
Jan 1, 2018
Primary completion
Dec 31, 2019 (estimated)
Completion
Jun 30, 2020 (estimated)
Last update
Dec 4, 2018

Study contacts

Orazio Genovese, MD
Contact
orazio.genovese@policlinicogemelli.it
0630153125
Giorgio Conti, MD
study chair · Università Cattolica del Sacro Cuore; Fondazione Policlinico Universitario Agostino Gemelli; IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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