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NCT00829842 Clinical Trial

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

Ventilator Associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00829842
Other study ID # HCRP 8904/2005
Secondary ID
Status Completed
Phase Phase 3
First received January 26, 2009
Last updated January 26, 2009
Start date February 2006
Est. completion date February 2006

Study information
Verified date January 2009
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Other:
• oral hygiene
oral hygiene with 0.12% chlorexidine
• placebo
oral hygiene placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
University of Sao Paulo
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