Oral Care and Gram-negative Pathogen in Children

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01410682

Enrollment

Registered

2011-08-05

Start date

2005-06-30

Completion date

2007-06-30

Last updated

2011-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal and Oropharyngeal Colonization by Gram-negative Pathogens

Keywords

oral hygiene, ventilator-associated pneumonia, infection control, intensive care, pediatric nursing, pediatrics

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.

Interventions

OTHER0,12% 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.

OTHERtoothbrushing

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

29 Days to 18 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026