跳至主要内容
临床试验/NCT07240038
NCT07240038招募中不适用

Evaluation of an Evidence Based, Bundled Intervention to Reduce Incidence of Ventilator-associated Pneumonia in Neonatal Units (INBERNAV-Neo)

Biocruces Bizkaia Health Research Institute39 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2024年4月26日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,500
试验地点
39
主要终点
Evaluation of the effect of a multimodal intervention, based on good clinical practices for the clinical management of neonates on invasive ventilatory support, on the incidence of VAP in neonates admitted to Spanish NICUs.

研究概览

简要总结

The aim of this project is to achieve useful, universal and standardized definitions for the diagnosis and prevention of ventilator-associated neumonia in patients in the Neonatal Intensive Care Unit (NICU). To this end, a set of recommendations and best practice protocols have been developed in which the healthcare team of the participating units will be trained. These protocols will include evidence-based recommendations for daily practice (oral care, suctioning practices, patient positioning...) and guidelines for the diagnosis, with the goal of improving and standardizing the care that is currently carried out in each unit.

To evaluate the extent to which this intervention helps to reduce the frequency of ventilator-associated pneumonia and minimize its impact, a surveillance registry of the patient on invasive mechanical ventilation will be carried out. This registry consists of the collection of general data (sex, type of delivery, gestational age...), the drugs used during the registry (use or not of antibiotics) and the duration of the period during which the patient is under surveillance. If the patient develops pneumonia during the duration of intubation, the clinical and radiological (and in some cases microbiological) data necessary for its diagnosis and the treatment used will be collected.

The study is composed of several phases, but if we exclude the phases of formation and structure of the teams, literature review, resource preparation and data processing, the study is composed of 3 clearly differentiated phases in which patients are included. In the first phase, the coordinating team will only give the researchers of each hospital access to the forms and a brief explanation of how to fill them in, but instructing them to follow the usual diagnostic criteria. Once an established period of time has finished, the whole team belonging to the NICUs included in the project will be trained. Finally, after the training period, the teams will incorporate the preventive measures and diagnostic criteria seen in the training to their usual practice. To track behavioral changes from one phase to the next, the researchers will fill out forms to monitor the implementation of measures. Once this last phase has been completed, the results obtained will be analysed and the changes in prevention and diagnosis will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.

排除标准

  • Patients who remain in IMV less than 48 hours.
  • Decision of the healthcare professional in charge of the patient's treatment to exclude their participation at any moment due to the considerations of necessity.

结局指标

主要结局

Evaluation of the effect of a multimodal intervention, based on good clinical practices for the clinical management of neonates on invasive ventilatory support, on the incidence of VAP in neonates admitted to Spanish NICUs.

时间窗: From the initiation of IMV until extubation plus an additional 2 days of monitoring in some cases.

次要结局

  • Standardization of a definition of VAP in neonates.(6 months.)
  • Certified and interactive online course on the Moodle platform for training healthcare professionals in standardized diagnosis and prevention of neonatal VAP.(15 months.)
  • Collection and analysis of antibiotic use data in the treatment of neonatal VAP.(28 months.)
  • Systematic literature review to identify the best available scientific evidence for the unification of diagnostic criteria for VAP in neonates, and to propose evidence-based preventive measures.(An initial literature collection period of 9 months, followed by continuous updates throughout 2 years.)
  • Secure and user-friendly web-based registry system (Neo-NAV) for participating centers to record episodes of invasive mechanical ventilation (and VAP, if present) in neonates.(28 months.)
  • To provide information and training on the use of telescoping catheter techniques for diagnostic purposes.(15 months.)
  • . Development of a dedicated section within the Neo-NAV platform for recording preventive measures implemented against VAP in neonates at each participating hospital.(Every 4 months during a 20-month period.)

研究者

发起方
Biocruces Bizkaia Health Research Institute
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Maria Cruz López Herrera

Lead investigator

Biocruces Bizkaia Health Research Institute

研究点 (39)

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