Cultures in PICU Patients Compared to Healthy Children

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Pneumonia, Bacterial; Ventilator Associated Pneumonia
• Intervention / Treatment: Diagnostic test: Culture/PCR Analysis

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

ICU Group:

• Intubated within 12 hours
• ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
• Age 2 to 8

OR Group:

• ASA 1 or 2
• Elective dental surgery requiring intubation
• Age 2 to 8

Description

Inclusion Criteria:

ICU Group:

• Intubated within 12 hours
• ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
• Age 2 to 8

OR Group:

• ASA 1 or 2
• Elective dental surgery requiring intubation
• Age 2 to 8

Exclusion Criteria:

ICU Group:

• Trauma patients
• Postoperative patients
• Children under 2 or over 8

OR Group:

• Received antibiotics within the last week
• Received prednisone within the last 2 weeks
• Viral respiratory infective process within the last 2 weeks

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ventilated Pediatric Intensive Care Unit patient Group; This will be a prospective descriptive case series where tracheal cultures and PCR results will be analyzed at initial intubation and again several days into the ICU stay.	Diagnostic test: Culture/PCR Analysis; Microbes 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
Intubated OR patient Control Group; For the healthy operating room children, also a case series where a single set of studies will be obtained. tracheal cultures and PCR results will be analyzed after intubation These two groups will be compared, non-randomized.	Diagnostic test: Culture/PCR Analysis; Microbes 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of bacteria in sample	PCR analysis	By January 2019
Presence of bacteria in sample	Culture analysis	By January 2019

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Christopher Heard, MBChB, FRCA, Jacobs School of Medicine

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Pneumonia; Pediatric; ICU; PCR; PICU; OR
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Bacterial; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: STUDY00001954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No