- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00829842
Oral Hygiene With Chlorhexidine and Incidence of Ventilator-Associated Pneumonia in Children Submitted to Heart Surgery
January 26, 2009 updated by: University of Sao Paulo
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
160
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2
|
oral hygiene with 0.12% chlorexidine
|
Placebo Comparator: 1
Placebo
|
oral hygiene placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Study Completion (Actual)
February 1, 2006
Study Registration Dates
First Submitted
January 26, 2009
First Submitted That Met QC Criteria
January 26, 2009
First Posted (Estimate)
January 27, 2009
Study Record Updates
Last Update Posted (Estimate)
January 27, 2009
Last Update Submitted That Met QC Criteria
January 26, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCRP 8904/2005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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