Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03418272

Cultures in PICU Patients Compared to Healthy Children

Oral and Tracheal Cultures in Pediatric ICU Patients Compared to Healthy Children

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
State University of New York at Buffalo · Academic / Other
Sex
All
Age
2 Years – 8 Years
Healthy volunteers

Summary

This study is being done to determine if the bacteria found in your mouth (oral flora bacteria) in children admitted to the intensive care unit who need to be on a breathing machine is different from the oral flora in healthy children undergoing anesthesia for their dental caries. Children in the intensive care unit with a breathing tube are at a higher risk for getting a lung infection due to the bacteria in the mouth slipping into their lungs past the breathing tube over several days. This means that bacteria are found in the child's lung when this is normally not the case. If the bacteria in the mouth have changed from normal then they may get a pneumonia.

Detailed description

The oral cavity has natural flora of microbiology that may be associated with the development of dental decay. Another possible problem arising from this flora is the migration of the bacteria into the trachea causing pulmonary infections such as trachietis or pneumonia. The risk of developing a pulmonary infection appears to be increased in patients who have been intubated for a period of time (days) such as those patients ventilated in the intensive care unit (ICU). It has also been shown that in patients in the ICU the nature of the oral flora changes over time to include bacteria that are more commonly associated with the nosocomial pneumonia, ventilator associated pneumonia. We have previous demonstrated in a small pilot study (CYIRB2779) that the changes in the oral flora in children intubated in the ICU was similar to those bacteria grown from tracheal cultures ordered by the intensivist. Patients intubated in the ICU maybe at risk of decreased salivary flow, sedated and unable to clear secretions and are reliant on the bedside nurse to maintain adequate oral hygiene. Most ICU's have guidelines and policies to ensure that oral hygiene is appropriately cared for. They are also at risk for changes in the oral flora due to concomitant broad-spectrum antibiotic use that is common in the initial 48 hours after admission with respiratory failure. The second are of interest is to determine whether children who are very sick and require intubation and ventilation support have different bugs growing in their mouth that may predispose them to future infection whilst in the ICU.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCulture/PCR AnalysisMicrobes to be selectively cultured and PCR analysis to be conducted. Bacteria obtained in samples will be dispersed in non-selective Mueller Hinton Broth (Sigma-Aldrich), divided into two separate cultures and grown overnight at 37°C in aerobic condition and in 5% CO2 to assure survival of both aerobic and facultative anaerobic species. * Staphylococcus aureus (MSSA, MRSA) * Pseudomonas aeruginosa * Haemophilus influenza * Streptococcus pneumonia * Streptococcus Pyogenes Group B streptococci, * Klebsiella pneumonia * Moraxella catarrhalis

Timeline

Start date
2023-02-01
Primary completion
2023-05-01
Completion
2023-09-01
First posted
2018-02-01
Last updated
2022-04-22

Source: ClinicalTrials.gov record NCT03418272. Inclusion in this directory is not an endorsement.