Oral Care and Gram-negative Pathogen in Children

August 4, 2011 updated by: Federal University of São Paulo

Oral Care and Oropharyngeal and Tracheal Colonization by Gram-negative Pathogens in Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

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

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 0.12% Chlorhexidine Digluconate
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.
Other: 0,12% digluconate chlorhexidine
Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.
Placebo Comparator: tothbrushing
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.
Other: toothbrushing
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Influence of chlorhexidine digluconate 0.12% on tracheal and oropharyngeal colonization by gram-negative pathogens

Secondary Outcome Measures

Outcome Measure
Influence of some demographic characteristics of critically ill children on the oropharynx Gram-negative pathogens identification.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

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

June 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 5, 2011

Last Update Submitted That Met QC Criteria

August 4, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORAL CARE

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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