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Surveillance of Neonatal Endotracheal Tube Colonisation (NETT)

2026年6月17日 更新者:University of Nottingham

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.

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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

观察性的

注册 (估计的)

80

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

Neonatal infants of all gestational ages

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Neonatal patients intubated and mechanically ventilated for more than 12 hours
80 neonatal patients across all gestational ages

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Microbial biofilm colonisation of ETT
大体时间:18 months
Mapping common neonatal pathogens involved in microbial colonisation of ETT on NICU
18 months

次要结果测量

结果测量
措施说明
大体时间
Ventilator-associated pneumonia
大体时间:18 months
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).
18 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Don Sharkey、University of Nottingham

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年6月17日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26020
  • 357143 (其他标识符:IRAS)
  • 26/WM/0115 (其他标识符:REC reference)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

No, there are no plans to share individual participant data (IPD) with other researchers.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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