Surveillance of Neonatal Endotracheal Tube Colonisation

NCT07664449 | Not Yet Recruiting

• 3 other identifiers: 2602035714326/WM/0115
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

Babies in neonatal intensive care units (NICUs) sometimes need help breathing using a breathing tube (endotracheal tube, or ETT) connected to a breathing machine (ventilator). Over time, bacteria and other substances can build up on the inside of these tubes. This build-up may contribute to infections, inflammation, or breathing problems, but we do not fully understand how often this occurs or what is present within the tubes used in UK NICUs. This surveillance study will collect breathing tubes that have been removed from babies who have been ventilated for more than 12 hours as part of their normal clinical care. No additional procedures or interventions will be performed on babies, and the tubes would otherwise be discarded. Researchers will examine the used tubes and any respiratory secretions (mucus) associated with them. Laboratory testing will identify any bacteria or other microorganisms present and analyse the chemical composition that has accumulated within the tubes and respiratory secretions. By studying these samples, we hope to better understand how breathing tubes become colonised over time and how this may relate to infection and lung health in newborn babies. This study aims to identify the microorganisms that colonises ETT and map them in a contemporary UK neonatal cohort. The information gained from this study may help improve infection surveillance, guide future research, and support the development of strategies to reduce complications associated with mechanical ventilation in vulnerable newborn infants.

Conditions

Ventilation, Mechanical; Ventilation-Associated Pneumonia

Keywords

ventilation; endotracheal tube colonisation; neonatal; biofilm colonisation

Outcome Measures

Primary Outcomes (1)

• Microbial biofilm colonisation of ETT

  Mapping common neonatal pathogens involved in microbial colonisation of ETT on NICU

  18 months

Secondary Outcomes (1)

• Ventilator-associated pneumonia

  18 months

Study Arms (1)

Neonatal patients intubated and mechanically ventilated for more than 12 hours

80 neonatal patients across all gestational ages

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Neonatal infants of all gestational ages

You may qualify if:

• Infant of any gestational age (22 weeks gestation and upwards) who is expected to be intubated for more than 12 hours
• All infants must have verbal or written informed consent from the parent/carer
• All infants must have a realistic prospect of survival as determined by the attending clinical team

You may not qualify if:

• Infants that are not for active resuscitation
• Infants that are undergoing end-of-life care
• In situations where consent is not possible or provided

Sponsors & Collaborators

• University of Nottingham: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Participant biospecimens (endotracheal tube and respiratory secretions) will be retained for microbiological and chemical analyses. These will not be retained following completion of the study analyses. No DNA extraction or genetic analysis will be performed.

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Don Sharkey

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shin Tan

CONTACT

shinhui.tan@nottingham.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share