Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children
| Tracking Information | |
|---|---|
| First Received Date ICMJE | March 5, 2010 |
| Last Updated Date | March 8, 2010 |
| Start Date ICMJE | June 2005 |
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Ventilator associated pneumonia [ Time Frame: 48 hours after tracheal intubation ] [ Designated as safety issue: No ] Influence of oral care with 0.12% chlorhexidine on VAP incidence diagnosed by clinical pulmonary infection score. |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT01083407 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Oral Care Interventions and Ventilator Associated Pneumonia in Critically Ill Children |
| Official Title ICMJE | Oral Care Interventions With 0.12% Chlorhexidine and Ventilator Associated Pneumonia in Critically Ill Children: Prospective, Randomic and Double Blind Study |
| Brief Summary | This experimental study aims to verify the influence of the oral hygiene performance with chlorhexidine digluconate 0.12% in the development of VAP in children. The data collection begun in April, 2005 during the performance of the masters degree course dissertation entitled "Clinical study about the effect of the oral hygiene with chlorhexidine digluconate 0.12% in the oropharynx colonization of children in intensive care", being performed in a PICU of nine beds in a university hospital in the city of São Paulo, after approval of the Research Ethics Committee of the institution. The study is composed by three types of variables: Independent variable, dependent variables, and complementary variables. The categorical variables will be analyzed in accordance with the Person's Chi-Square test of or Fisher's exact test. The numerics will be submitted to the analysis of variance ANOVA or Kruskall Wallis. For variables with heterogeneous distribution between the groups, the multivariate analysis will be applied to the evaluation of the influence in the determination of the development risk of the dependent variable. The rejection level will be fixed in 0.05 of the nullity hypothesis. |
| Detailed Description | Recent progress in identification of oral microorganisms has shown that the oropharynx can be a site of origin for dissemination of pathogenic organisms to distant body sites, such as the lungs. THe aims of the study were to compare the oropharyngeal microbiological profile, VAP incidence, duration of mechanical ventilation, and length of stay in the intensive care unit of children receiving mechanical ventilation who had pharmacological or nonpharmacological oral care. A randomized and controlled study has been performed in a pediatric intensive unit in São Paulo, Brazil. The children are randomly assigned to an experimental group that received oral care with use of 0.12% chlorhexidine digluconate or a control group that received oral care without an antiseptic. Oropharyngeal and tracheal secretions were collected and cultured on days 0, 2, and 4, and at discharge. |
| Study Type ICMJE | Interventional |
| Study Phase | Phase 1 |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Condition ICMJE | Ventilator Associated Pneumonia |
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Kusahara DM, Friedlander LT, Peterlini MA, Pedreira ML. Oral care and oropharyngeal and tracheal colonization by Gram-negative pathogens in children. Nurs Crit Care. 2012 May;17(3):115-22. doi: 10.1111/j.1478-5153.2012.00494.x. Epub 2012 Feb 23. |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 146 |
| Completion Date | June 2008 |
| Primary Completion Date | June 2006 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | up to 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01083407 |
| Other Study ID Numbers ICMJE | Oral care and VAP in children. |
| Has Data Monitoring Committee | No |
| Responsible Party | Federal University of São Paulo, Nursing Department |
| Study Sponsor ICMJE | Federal University of São Paulo |
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo |
| Investigators ICMJE | Not Provided |
| Information Provided By | Federal University of São Paulo |
| Verification Date | March 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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