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Clinical Trials/NCT00597688
NCT00597688
Completed
Phase 3

Oral Mucosal Decontamination With Chlorhexidine for Prevention of Ventilator Associated Pneumonia in Children - A Randomized Controlled Trial

All India Institute of Medical Sciences, New Delhi1 site in 1 country86 target enrollmentNovember 2007

Overview

Phase
Phase 3
Intervention
Chlorhexidine gel
Conditions
Ventilator Associated Pneumonia
Sponsor
All India Institute of Medical Sciences, New Delhi
Enrollment
86
Locations
1
Primary Endpoint
Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The purpose of this study is to determine if oral mucosal application of chlorhexidine gel will prevent the development of ventilator associated pneumonia in children.

Detailed Description

Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in certain settings. A number of preventive methods have been studied to reduce the rate of VAP but a consensus is lacking with regards to appropriate preventive strategies. Studies in adults have shown a beneficial effect of oral mucosal application of chlorhexidine but similar studies in pediatric population are not available. This research project aims at addressing the gap.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
April 2009
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
All India Institute of Medical Sciences, New Delhi

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Chlorhexidine gel

Intervention: Chlorhexidine gel

2

Placebo gel

Intervention: Placebo gel

Outcomes

Primary Outcomes

Occurrence of ventilator associated pneumonia as defined by CDC diagnostic criteria

Time Frame: 21 days

Secondary Outcomes

  • Antibiotic sensitivity of organism cultured(21 days)
  • Duration of hospital stay(21 days)
  • Duration of ICU stay(21 days)
  • In hospital mortality rate(21 days)

Study Sites (1)

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