Oral Care and Gram-negative Pathogen in Children

Not Applicable

Completed

• Conditions: Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens
• Interventions: Other: 0,12% digluconate chlorhexidine; Other: toothbrushing

• Registration Number: NCT01410682
• Lead Sponsor: Federal University of São Paulo

Brief Summary

Critical care nursing interventions related to oral care can reduce the microorganisms in the oropharynx available for translocation to other sites. THis is a randomized, controlled and double blinded study performed in a pediatric intensive care unit (PICU) from a Brazilian university hospital which objectives were to analyze 0.12% chlorhexidine digluconate influence on Gram-negative pathogens colonization of oropharyngeal and tracheal secretions of mechanically ventilated children.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2011-07
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Last Update Submitted: 2011-08-04
• Study First Posted: 2011-08-05
• Last Update Posted: 2011-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• All the PICU children during 24 months of study were selected for participation.

Exclusion Criteria

• newborns, those that fulfilled the Centers for Disease Control and Prevention criteria for pneumonia in infants and children at the time of PICU admission, PICU LOS less than 48 hours, presence of tracheostomy and those that declined to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.12% Chlorhexidine Digluconate	0,12% digluconate chlorhexidine	Oral care included use of an oral gel containing chlorhexidine digluconate 0.12% as an active ingredient (chlorhexidine digluconate 0.12%; methylcellulose gel 2.12%, 25 g; gooseberry syrup, 4 drops; menthol solution 50%,3 drops; and distilled water, to 30 g).The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular,lingual, occlusal, and incisal). After each quadrant was cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto- anterior movements.
tothbrushing	toothbrushing	This group received the same oral care that experimental group with the use of a similarly formulated gel without the antiseptic agent.The gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posterior to anterior movements.

Primary Outcome Measures

Name	Time	Method
Influence of chlorhexidine digluconate 0.12% on tracheal and oropharyngeal colonization by gram-negative pathogens

Secondary Outcome Measures

Name	Time	Method
Influence of some demographic characteristics of critically ill children on the oropharynx Gram-negative pathogens identification.