Cultures in PICU Patients Compared to Healthy Children

NCT03418272 | Withdrawn

• 1 other identifier: STUDY00001954
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ventilator Associated Pneumonia; Pneumonia, Bacterial

Keywords

ICU; OR; Pneumonia; PICU; Pediatric; PCR

Outcome Measures

Primary Outcomes (2)

• Percentage of bacteria in sample

  PCR analysis

  By January 2019

• Presence of bacteria in sample

  Culture analysis

  By January 2019

Study Arms (2)

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

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

Interventions

Culture/PCR Analysis DIAGNOSTIC_TEST

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; Ventilated Pediatric Intensive Care Unit patient Group

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Christopher Heard, MBChB, FRCA

  Jacobs School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Anesthesiology

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 1, 2018
• Study Start: February 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share