Airway Microbiome Changes After Artificial Airway Exchange in Critically-ill Pediatric Patients.

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.

Study Overview

• Status: Recruiting
• Conditions: Tracheostomy; Microbial Colonization; Ventilator Associated Pneumonia; Endotracheal Tube; Pediatrics; Pediatric Infectious Disease; Tracheitis
• Intervention / Treatment: Diagnostic test: Suctioning of artificial airway

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Evin S Feldman, MD; Phone Number: (516) 562-3467; Email: efeldman4@northwell.edu
• Study Contact Backup: Name: Mariana R Brewer, MD; Phone Number: (516) 562-3467; Email: mbrewer@northwell.edu

Study Locations

• United States
  • New York
    • Queens, New York, United States, 11040
      • Recruiting
      • Cohen Children's Medical Center
      • Contact: Evin S Feldman, MD; Phone Number: 718-470-3350; Email: efeldman4@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shannon diversity index	A measure of alpha diversity	December 2023-June 2025
Bray-curtis dissimilarity	A measure of beta diversity	December 2023-June 2025
Differential abundance		December 2023-June 2025

Collaborators and Investigators

• Sponsor: Northwell Health

Publications and helpful links

General Publications

• Mitchell RB, Hussey HM, Setzen G, Jacobs IN, Nussenbaum B, Dawson C, Brown CA 3rd, Brandt C, Deakins K, Hartnick C, Merati A. Clinical consensus statement: tracheostomy care. Otolaryngol Head Neck Surg. 2013 Jan;148(1):6-20. doi: 10.1177/0194599812460376. Epub 2012 Sep 18.
• Kuhl LP, Marostica PJC, Macedo AJ, Kuhl G, Siebert M, Manica D, Sekine L, Schweiger C. High microbiome variability in pediatric tracheostomy cannulas in patients with similar clinical characteristics. Braz J Otorhinolaryngol. 2023 Mar-Apr;89(2):254-263. doi: 10.1016/j.bjorl.2022.05.001. Epub 2022 May 20.
• Maffei D, Brewer M, Codipilly C, Weinberger B, Schanler RJ. Early oral colostrum administration in preterm infants. J Perinatol. 2020 Feb;40(2):284-287. doi: 10.1038/s41372-019-0556-x. Epub 2019 Nov 20.
• Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Freishtat RJ, Mansbach JM. The temporal dynamics of the tracheal microbiome in tracheostomised patients with and without lower respiratory infections. PLoS One. 2017 Aug 10;12(8):e0182520. doi: 10.1371/journal.pone.0182520. eCollection 2017.
• Perez-Losada M, Graham RJ, Coquillette M, Jafarey A, Castro-Nallar E, Aira M, Hoptay C, Freishtat RJ, Mansbach JM. Tracheal Microbiota in Patients With a Tracheostomy Before, During and After an Acute Respiratory Infection. Pediatr Infect Dis J. 2018 Nov;37(11):e269-e271. doi: 10.1097/INF.0000000000001952.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Estimated): June 26, 2025
• Study Completion (Estimated): June 26, 2025

Study Registration Dates

• First Submitted: December 29, 2023
• First Submitted That Met QC Criteria: December 29, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Tracheal Diseases; Infections; Communicable Diseases; Pneumonia, Ventilator-Associated; Tracheitis
• Other Study ID Numbers: IRB-23-0420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Can share identified data

Drug and device information, study documents

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