Clinical trial NCT06201130: Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.
Official title: Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy
Endotracheal Tube
Ventilator Associated Pneumonia
Tracheitis
Microbial Colonization
Pediatric Infectious Disease
Pediatrics
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects included will be children aged 0-18 years of all sexes, ethnic and racial backgrounds. Subjects will generally be ill and have many comorbid conditions, as patients with artificial airways in the PICU and NICU tend to have complex issues. There are no exclusion criteria. Children must be included as this study wishes to understand the impact of exchanging artificial airways in the pediatric population.

Brief summary: Artificial airways, such as endotracheal tubes and tracheostomies, in the pediatric and neonatal intensive care units (PICU, NICU respectively) are lifesaving for patients in respiratory failure, among other conditions. These devices are not without a risk of infection - ventilator-associated infections (VAIs), namely ventilator associated pneumonia (VAP) and ventilator-associated tracheitis (VAT), are common. Treatment of suspected VAI accounts for nearly half of all Pediatric Intensive Care Unit (PICU) antibiotic use. VAI can represent a continuum from tracheal colonization, progression to tracheobronchial inflammation, and then pneumonia. Colonization of these airways is common and bacterial growth does not necessarily indicate a clinically significant infection. Tracheostomies, which are artificial airways meant for chronic use, are routinely exchanged on a semi-monthly to monthly basis, in part to disrupt bacterial biofilm formation that aids bacterial colonization and perhaps infection. When patients with tracheostomies are admitted for acute on chronic respiratory failure or a concern for an infection, these artificial airways are also routinely exchanged at some institutions. There however remains a critical need to understand how an artificial airway exchange alters the bacterial environment of these patients in sickness and in health. This research hypothesizes that exchanging an artificial airway will alter the microbiome of the artificial airway, by altering the microbial diversity and relative abundance of different bacterial species of the artificial airway. This study will involve the prospective collection of tracheal aspirates from patients with artificial airways. We will screen and enroll all patients admitted to a the NICU or PICU at Cohen Children's Medical Center (CCMC) who have tracheostomies and obtain tracheal aspirates within 72 hours before and after tracheostomy or endotracheal tube exchange. Tracheal aspirates are routinely obtained in the NICU and PICU from suctioning of an artificial airway and is a minimal risk activity. These samples will be brought to the Feinstein Institutes for Medical Research for 16 s ribosomal DNA (16srDNA) sequencing, which allows for accurate and sensitive detection of relative abundance and classification of bacterial flora. Tracheal aspirate sets will be analyzed against each other. Additionally, clinical and epidemiological data from the electronic medical record will be obtained. Antibiotic exposure will be accounted for via previously published means.


Eligibility criteria: Inclusion Criteria:

* All patients with tracheostomies in the pediatric or neonatal intensive care unit
* Patients with endotracheal tubes undergoing artificial airway exchange in the pediatric or neonatal intensive care unit

Exclusion Criteria:

* None

Primary outcomes:
measure: Shannon diversity index
timeFrame: December 2023-June 2025
measure: Bray-curtis dissimilarity
timeFrame: December 2023-June 2025
measure: Differential abundance
timeFrame: December 2023-June 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Queens
country: United States
facility: Cohen Children's Medical Center
state: New York
Study officials:
References:
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citation: Zachariah P, Ryan C, Nadimpalli S, Coscia G, Kolb M, Smith H, Foca M, Saiman L, Planet PJ. Culture-Independent Analysis of Pediatric Bronchoalveolar Lavage Specimens. Ann Am Thorac Soc. 2018 Sep;15(9):1047-1056. doi: 10.1513/AnnalsATS.201802-146OC.