Ventilation, MechanicalNETTNCT07664449
Surveillance of Neonatal Endotracheal Tube Colonisation
An observational study of Ventilation, Mechanical and Ventilation-Associated Pneumonia, run by University of Nottingham.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ventilation, Mechanical, Ventilation-Associated Pneumonia
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Neonatal infants of all gestational ages
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Shin Tan contact
About this study
Official title: Surveillance Study of Endotracheal Tube Microbial Colonisation in Neonatal Intensive Care Units
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.
Read more
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.
Read the detailed description
Every year, over 90,000 babies, including 20,000 preterm infants, are admitted to UK neonatal units. Globally, 13.4 million babies are born prematurely and are at high-risk of dying or developing long-term disease or disability. Preterm infants are more susceptible to late-onset infections (LOIs, which include bacterial, viral and fungal) due to their immature immune systems, with reduced innate and adaptive immunity. These occur after 72 hours of age and are associated with significant mortality (13-19%) and morbidity in high-risk infants. Published studies, have demonstrated LOIs in preterm infants are associated with the development of bronchopulmonary dysplasia (BPD), a life-long severe breathing condition caused by infection, inflammation and abnormal lung development. Ventilator-associated pneumonia (VAP) is a leading cause of LOI in infants, causing significant mortality, morbidity and increasing length of ventilation and hospital stay. In preterm infants, LOIs are associated with a 2-4-fold increase in neurodevelopmental impairment (NDI) and cerebral palsy. Both LOIs and BPD are associated with severe NDI, which is estimated to reduce the infant's life expectancy by 15 years and increase NHS costs by £19,000. In England and Wales in 2020, 55% of preterm infants born at <28 weeks gestation either died or had severe BPD, and 88% were ventilated soon after birth for an average of 12 days, equating to >23,000 ETT ventilated days in this population alone.
Newborn infants admitted to neonatal units have never gone home and so in most cases acquire LOIs in hospital i.e., hospital-acquired infections. Many require life support from medical devices such as endotracheal tubes (ETT), nasogastric tubes, intravenous lines and incubators. Whilst lifesaving, up to 76% of these devices become colonised with pathogenic microbial biofilms, usually within 24 hours of use. Microbial attachment, or colonisation, to the surface of medical device can develop into surface-associated "slime layers", these are up to 1000 times more resistant to antibiotic and host immune system clearance making eradication unlikely. In ventilated preterm infants, 82% of ETTs become colonised and this is associated with a 4.5-fold increase in the risk of septicaemia. Even prepared but unused neonatal ETTs rapidly become colonised with up to three different organisms in 79% of cases. These biofilms pose an infection risk to highly vulnerable infants, especially those born prematurely where an adverse airway microbiome is associated with BPD progression and severity.
Every year in Europe and North America alone, over 38,000 surviving preterm babies develop BPD, affecting long-term respiratory health and cognitive development. Neonatal antimicrobial clinical trials aimed at reducing LOI and/or BPD do not address the optimal approach of avoiding or significantly reducing antimicrobial use (antibiotic stewardship), which can result in resistance, by using novel approaches to prevent biofilm formation and subsequent infection.
At present, there is a paucity of data of microbial biofilm colonisation of ETT in a contemporary UK neonatal population. We proposed conducting the first surveillance study on microbial colonisation and biofilm transformation in ETT in two neonatal units in the UK. This surveillance study will provide invaluable data, helping us to better understand biofilm formation within the neonatal population, and map the common neonatal pathogens in a contemporary UK neonatal cohort. The results from this surveillance study will inform the planning of future research to reduce biofilm colonisation within ETT.
- Keywords
- ventilation, endotracheal tube colonisation, neonatal, biofilm colonisation
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal patients intubated and mechanically ventilated for more than 12 hours | 80 neonatal patients across all gestational ages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial biofilm colonisation of ETT
Mapping common neonatal pathogens involved in microbial colonisation of ETT on NICU
Measured: 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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilation, MechanicalStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don Sharkey, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664449
- Sponsor's protocol ID
- 26020
- Other IDs
- 357143, 26/WM/0115
- Acronym
- NETT
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, there are no plans to share individual participant data (IPD) with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Study of Endotracheal Tube Microbial Colonisation in Neonatal Intensive Care Units
- ClinicalTrials.gov ID
- NCT07664449
- Acronym / sponsor ID
- NETT / 26020
- Keywords
- ventilation, endotracheal tube colonisation, neonatal, biofilm colonisation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Every year, over 90,000 babies, including 20,000 preterm infants, are admitted to UK neonatal units. Globally, 13.4 million babies are born prematurely and are at high-risk of dying or developing long-term disease or disability. Preterm infants are more susceptible to late-onset infections (LOIs, which include bacterial, viral and fungal) due to their immature immune systems, with reduced innate and adaptive immunity. These occur after 72 hours of age and are associated with significant mortality (13-19%) and morbidity in high-risk infants. Published studies, have demonstrated LOIs in preterm infants are associated with the development of bronchopulmonary dysplasia (BPD), a life-long severe breathing condition caused by infection, inflammation and abnormal lung development. Ventilator-associated pneumonia (VAP) is a leading cause of LOI in infants, causing significant mortality, morbidity and increasing length of ventilation and hospital stay. In preterm infants, LOIs are associated with a 2-4-fold increase in neurodevelopmental impairment (NDI) and cerebral palsy. Both LOIs and BPD are associated with severe NDI, which is estimated to reduce the infant's life expectancy by 15 years and increase NHS costs by £19,000. In England and Wales in 2020, 55% of preterm infants born at <28 weeks gestation either died or had severe BPD, and 88% were ventilated soon after birth for an average of 12 days, equating to >23,000 ETT ventilated days in this population alone.
Newborn infants admitted to neonatal units have never gone home and so in most cases acquire LOIs in hospital i.e., hospital-acquired infections. Many require life support from medical devices such as endotracheal tubes (ETT), nasogastric tubes, intravenous lines and incubators. Whilst lifesaving, up to 76% of these devices become colonised with pathogenic microbial biofilms, usually within 24 hours of use. Microbial attachment, or colonisation, to the surface of medical device can develop into surface-associated "slime layers", these are up to 1000 times more resistant to antibiotic and host immune system clearance making eradication unlikely. In ventilated preterm infants, 82% of ETTs become colonised and this is associated with a 4.5-fold increase in the risk of septicaemia. Even prepared but unused neonatal ETTs rapidly become colonised with up to three different organisms in 79% of cases. These biofilms pose an infection risk to highly vulnerable infants, especially those born prematurely where an adverse airway microbiome is associated with BPD progression and severity.
Every year in Europe and North America alone, over 38,000 surviving preterm babies develop BPD, affecting long-term respiratory health and cognitive development. Neonatal antimicrobial clinical trials aimed at reducing LOI and/or BPD do not address the optimal approach of avoiding or significantly reducing antimicrobial use (antibiotic stewardship), which can result in resistance, by using novel approaches to prevent biofilm formation and subsequent infection.
At present, there is a paucity of data of microbial biofilm colonisation of ETT in a contemporary UK neonatal population. We proposed conducting the first surveillance study on microbial colonisation and biofilm transformation in ETT in two neonatal units in the UK. This surveillance study will provide invaluable data, helping us to better understand biofilm formation within the neonatal population, and map the common neonatal pathogens in a contemporary UK neonatal cohort. The results from this surveillance study will inform the planning of future research to reduce biofilm colonisation within ETT.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal patients intubated and mechanically ventilated for more than 12 hours | – | –80 neonatal patients across all gestational ages |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Neonatal infants of all gestational ages
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Infants that are not for active resuscitation
- Infants that are undergoing end-of-life care
- In situations where consent is not possible or provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Microbial biofilm colonisation of ETT
Time frame: 18 months
Mapping common neonatal pathogens involved in microbial colonisation of ETT on NICU
1 secondary outcome
Ventilator-associated pneumonia
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. No, there are no plans to share individual participant data (IPD) with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shin Tan contact
Don Sharkey principal investigator
University of Nottingham
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilation, Mechanical and Ventilation-Associated Pneumonia, run by University of Nottingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shin Tan (shinhui.tan@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial biofilm colonisation of ETT (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.