Reduction of the Incidence of NAV in Neonatal Units (INBERNAV-Neo)

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Multimodal intervention to reduce the incidence of ventilator-associated pneumonia by training the health care team in specific and general evidence-based good clinical practices.
  Bibliographical search and analysis to identify and prioritize effective and feasible interventions and procedures. Consensus among professionals for its adaptation to our Healthcare System. Areas of intervention: Hand hygiene: before and after patient contact and handling of respiratory equipment. Intubation: new and sterile ETT every intubation attempt; no contact with any non-sterile surface before insertion; avoid reintubation; ≥ two professionals. Suctioning: obstruction or increased res
• Диагностический тест Technique with a blind-protected catheter
  Through the use of an invasive technique with a blind-protected catheter, the possibility of contamination and the incidence of polymicrobial etiology is reduced, resulting in a sensitive and accurate diagnosis. The method employed in this study has previously been shown to be feasible, reproducible, safe, and comparable to bronchoscopic methods for identifying VAP in children, providing sterile access to the lower respiratory tract.

Первичные конечные точки

• 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. [Срок оценки: From the initiation of IMV until extubation plus an additional 2 days of monitoring in some cases.]

Вторичные конечные точки (7)

• 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. [Срок оценки: 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. [Срок оценки: 28 months.]
• Certified and interactive online course on the Moodle platform for training healthcare professionals in standardized diagnosis and prevention of neonatal VAP. [Срок оценки: 15 months.]
• To provide information and training on the use of telescoping catheter techniques for diagnostic purposes. [Срок оценки: 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. [Срок оценки: Every 4 months during a 20-month period.]
• Standardization of a definition of VAP in neonates. [Срок оценки: 6 months.]
• Collection and analysis of antibiotic use data in the treatment of neonatal VAP. [Срок оценки: 28 months.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Испания · 39 центров

• Hospital Universitario de A Coruña — A Coruña
• Hospital Clínico Universitario de Santiago — Santiago de Compostela
• Complejo Hospitalario Universitario de Albacete — Albacete
• Hospital Universitario Germans Trias i Pujol — Badalona
• Hospital de la Santa Creu i Sant Pau — Barcelona
• Hospital Universitario Vall d'Hebrón — Barcelona
• Hospital Universitario de Cruces — Barakaldo
• Hospital Universitario de Basurto — Bilbao
• … и ещё 31 центр

Публикации

• Williams L. Ventilator-Associated Pneumonia Precautions for Children: What Is the Evidence? AACN Adv Crit Care. 2019 Spring;30(1):68-71. doi: 10.4037/aacnacc2019812. No abstract available. PMID 30842077
• Williams EE, Arattu Thodika FMS, Chappelow I, Chapman-Hatchett N, Dassios T, Greenough A. Diaphragmatic electromyography during a spontaneous breathing trial to predict extubation failure in preterm infants. Pediatr Res. 2022 Oct;92(4):1064-1069. doi: 10.1038/s41390-022-02085-w. Epub 2022 May 6. PMID 35523885
• WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/ PMID 23805438
• Wang L, Du KN, Zhao YL, Yu YJ, Sun L, Jiang HB. Risk Factors of Nosocomial Infection for Infants in Neonatal Intensive Care Units: A Systematic Review and Meta-Analysis. Med Sci Monit. 2019 Nov 1;25:8213-8220. doi: 10.12659/MSM.917185. PMID 31675354
• Wang HC, Liao CC, Chu SM, Lai MY, Huang HR, Chiang MC, Fu RH, Hsu JF, Tsai MH. Impacts of Multidrug-Resistant Pathogens and Inappropriate Initial Antibiotic Therapy on the Outcomes of Neonates with Ventilator-Associated Pneumonia. Antibiotics (Basel). 2020 Oct 30;9(11):760. doi: 10.3390/antibiotics9110760. PMID 33143219
• van Leuteren RW, de Waal CG, de Jongh FH, Bem RA, van Kaam AH, Hutten G. Diaphragm Activity Pre and Post Extubation in Ventilated Critically Ill Infants and Children Measured With Transcutaneous Electromyography. Pediatr Crit Care Med. 2021 Nov 1;22(11):950-959. doi: 10.1097/PCC.0000000000002828. PMID 34534162
• Tusor N, De Cunto A, Basma Y, Klein JL, Meau-Petit V. Ventilator-associated pneumonia in neonates: the role of point of care lung ultrasound. Eur J Pediatr. 2021 Jan;180(1):137-146. doi: 10.1007/s00431-020-03710-8. Epub 2020 Jun 26. PMID 32592026
• Thibeau S, Boudreaux C. Exploring the use of mothers' own milk as oral care for mechanically ventilated very low-birth-weight preterm infants. Adv Neonatal Care. 2013 Jun;13(3):190-7. doi: 10.1097/ANC.0b013e318285f8e2. PMID 23722491

Идентификаторы

NCT: NCT07240038 · INBERNAV-Neo-21/01513 · PI2024002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗