Surveillance of Neonatal Endotracheal Tube Colonisation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Nottingham

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Infants that are not for active resuscitation

Infants that are undergoing end-of-life care

In situations where consent is not possible or provided

Trial population

Neonatal infants of all gestational ages

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 1 trial group
Group A: Neonatal patients intubated and mechanically ventilated for more than 12 hours

Trial outcomes

Primary outcomes

1

Microbial biofilm colonisation of ETT

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

Time frame
18 months

Secondary outcomes

1

Ventilator-associated pneumonia

Incidence rate of ventilator-associated pneumonia in neonatal infants with positive microbiological cultures from their respective ETT samples, confirmed by chest X-ray changes and clinical decision to treat infant with antibiotics (based on clinical and radiological examination findings).

Time frame
18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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