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Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00829842
Collaborator
(none)
160
Enrollment
2
Arms

Study Details

Study Description

Brief Summary

Hospital infections play an important role in the increase of patients' morbimortality and hospitalization costs, especially in the case of individuals admitted to intensive care units (ICU) during postoperative heart surgery. Analysis of the epidemiological profile of the hospital infections in the pediatric-ICU (P-ICU) of Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto, University of São Paulo (HCFMRP-USP) demonstrated a 31.1% incidence of pneumonia (PNM) and a rate of ventilator-associated pneumonia (VAP) of 23.81 per 1000 ventilators-day between March 2004 and February 2005 in the group submitted to cardiac surgery. Knowledge of the pathophysiology and risk factors associated with this infection allows for measures aiming at reducing its incidence. The objective of the present study is to evaluate the effect of oral hygiene with a 0.12% chlorhexidine solution on the incidence of PNM and PAV in children submitted to cardiac surgery.

Condition or Disease Intervention/Treatment Phase
  • Other: oral hygiene
  • Other: placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Evaluation of Oral Hygiene With 0.12% Chlorhexidine Antiseptic Solution on the Incidence of Nosocomial Pneumonia and Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
Study Start Date :
Feb 1, 2006
Actual Study Completion Date :
Feb 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: 1

Placebo

Other: placebo
oral hygiene placebo
Experimental: 2

Other: oral hygiene
oral hygiene with 0.12% chlorexidine

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age 0 to 18 years submitted to heart surgery

    • parent approval

    Exclusion Criteria:

    • previous oral intubation

    • previous or present pneumonia

    • parent refusal

    • death during surgery

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00829842
    Other Study ID Numbers:
    • HCRP 8904/2005
    First Posted:
    Jan 27, 2009
    Last Update Posted:
    Jan 27, 2009
    Last Verified:
    Jan 1, 2009
    Keywords provided by , ,
    chlorexidine
    ventilator-associated pneumonia
    nosocomial pneumonia
    heart surgery
    oral hygiene
    Additional relevant MeSH terms:
    Pneumonia
    Pneumonia, Ventilator-Associated
    Healthcare-Associated Pneumonia

    Study Results

    No Results Posted as of Jan 27, 2009