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 volunteersQualifiers
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
Other
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Microbial biofilm colonisation of ETT
Mapping common neonatal pathogens involved in microbial colonisation of ETT on NICU
Secondary outcomes
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).
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: