Ventilator Associated PneumoniaNCT03418272
Cultures in PICU Patients Compared to Healthy Children
An observational study of Ventilator Associated Pneumonia and Pneumonia, Bacterial, run by State University of New York at Buffalo.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Ventilator Associated Pneumonia, Pneumonia, Bacterial
- What is being tested?
- Culture/PCR Analysis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2023to Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- Child
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Being tested
- Culture/PCR Analysis
- Keywords
- ICU, OR, Pneumonia, PICU, Pediatric, PCR
- Medical subject headings
- Pneumonia, Ventilator-Associated, Pneumonia, Bacterial, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culture/PCR AnalysisDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Culture/PCR Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of bacteria in sample
PCR analysis
Measured: By January 2019
Presence of bacteria in sample
Culture analysis
Measured: By January 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study startFeb 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Study withdrawn until time and staff allow its completion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Heard, State University of New York at Buffalo
- Investigators
- Christopher Heard, MBChB, FRCA, Principal investigator, Jacobs School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418272
- Sponsor's protocol ID
- STUDY00001954
- Status last verified
- Apr 2022
- First submitted
- 25 Jan 2018
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Tracheal Cultures in Pediatric ICU Patients Compared to Healthy Children
- ClinicalTrials.gov ID
- NCT03418272
- Acronym / sponsor ID
- STUDY00001954
- Keywords
- ICU, OR, Pneumonia, PICU, Pediatric, PCR
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn until time and staff allow its completion.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilated Pediatric Intensive Care Unit patient Group | – | Diagnostic Test: Culture/PCR AnalysisThis 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. |
| Intubated OR patient Control Group | – | Diagnostic Test: Culture/PCR AnalysisFor 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (8 listed)
- Intubated within 12 hours
- ASA 1 or 2 (ASA - AMERICAN SOCIETY ANESTEHESIOLOGY PREOPOERATIVE STATUS)
- Age 2 to 8
- ASA 1 or 2
- Elective dental surgery requiring intubation
Key exclusion criteria (8 listed)
- Trauma patients
- Postoperative patients
- Children under 2 or over 8
- Received antibiotics within the last week
- Received prednisone within the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culture/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 | Diagnostic test | Intubated OR patient Control Group, Ventilated Pediatric Intensive Care Unit patient Group |
Primary outcome
Percentage of bacteria in sample
Time frame: By January 2019
PCR analysis
Presence of bacteria in sample
Time frame: By January 2019
Culture analysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Heard, MBChB, FRCA principal investigator
Jacobs School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator Associated Pneumonia and Pneumonia, Bacterial, run by State University of New York at Buffalo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of bacteria in sample (time frame: By January 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.