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Completed

NCT Number: NCT01410682

Oral Care and Gram-negative Pathogen 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.

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Key information

Conditions

Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

29 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

0,12% digluconate chlorhexidine

Other

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.

Toothbrushing

Other

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 outcomes

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

Secondary outcomes

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

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Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 5, 2011
Registry last updated
Aug 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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