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

NCT07240038 — Recruiting, 1500 participants, Biobizkaia Health Research Institute

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

Registry	NCT07240038, acronym INBERNAV-Neo
Status	Recruiting
Study type	Observational
Enrollment	1500 (Estimated)
Sponsor	Biobizkaia Health Research Institute (Other gov); collaborators: Carlos III Health Institute, Instituto de Investigacion Sanitaria La Fe, European Union, Hospital Universitario 12 de Octubre, Hospital HM Montepríncipe, Hospital General Universitario Gregorio Marañon, Hospital Universitario La Paz, Clinica Universidad de Navarra, Universidad de Navarra, Hospital General Universitario de Castellón, Hospital Clínico Universitario de Valencia, Hospital Donostia, Hospital de Basurto, Complejo Hospitalario Universitario de Pontevedra, Hospital Universitario de Burgos, Hospital Clinico Universitario de Santiago, Hospital Universitari de la Vall de Hebron, Hospital of Navarra, Hospital San Pedro de Alcantara, Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain, Hospital Universitario Central de Asturias, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío, Complejo Hospitalario de Jaen, Hospital Universitario Puerta del Mar, Hospital Universitario de Jerez de la Frontera, Hospital Materno-Infantil de Málaga, Hospital General Universitario Santa Lucía, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario La Fe, Salamanca University Hospital, Complexo Hospitalario Universitario de A Coruña, Red Salud Materno Infantil y del Desarrollo, Hospital de la Santa creu i Sant Pau - Barcelona, University Hospital Virgen de las Nieves, Germans Trias i Pujol Hospital, Hospital del Rio Hortega, Hospital Arnau de Vilanova
Conditions	Pneumonia Ventilator Associated, Pneumonia Neonatal, Healthcare-associated Infections
Interventions	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., Technique with a blind-protected catheter (Behavioral, diagnostic test)
Dates	start 2024-04-26, primary completion 2025-12-01 (estimated), completion 2026-06-30 (estimated), first posted 2025-11-20, last updated 2025-11-20
Locations	39 sites in Spain

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Patients admitted to participating NICUs who require mechanical ventilation		Behavioral: 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.; Diagnostic Test: Technique with a blind-protected catheter

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. (Behavioral): 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 respiratory secretions, never routinely. Two professional. Double suction system: one for oral cavity and one for airway, both connected to a closed suction system. Prior to ETT manipulation, patient repositioning, extubation or reintubation. Feeding: adjust to avoid large debris and/or distension. Positioning: lateral decubitus; head 15-30°; lateral left after feeding. Oral care: Sterile water or breast milk before intubation; every 4 h and before orogastric tube insertion. .
Technique with a blind-protected catheter (Diagnostic test): 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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.]: The search will be conducted in major biomedical databases (PubMed, EMBASE, Cochrane Library, Scopus). The strategy will use MeSH and keywords related to VAP and neonatal populations, such as "ventilator-associated pneumonia," "VAP," "neonatal," and "mechanical ventilation." Filters will limit results to English and Spanish publications from 2015-2023, with periodic updates. Studies included will be randomized trials, cohort, case-control, reviews, and meta-analyses that assess preventive interventions or diagnostic procedures for VAP in neonates. Selected studies must describe applied methods and report quantifiable outcomes for VAP incidence or reduction. The analysis will focus on neonatal care, especially in NICUs. This approach enables synthesis of high-quality evidence, standardizes criteria, and identifies effective preventive strategies. The review will document practical interventions (hand hygiene, patient positioning, early extubation) and knowledge gaps.
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.]: This registry will collect demographic, clinical, and diagnostic data, including clinical, radiological, and microbiological criteria. Standardized forms will ensure consistency across centers, capturing variables such as coded patient ID, date of VAP diagnosis, criteria used, lab and imaging results, and treatments. The coordinating team will monitor and analyze data, communicate directly with participating centers, and prepare global reports for all investigators. This process will support comparison of diagnostic practices and assessment of inter-center variability. Data security and confidentiality will be ensured via regulatory compliance, restricted access, and audit systems. The platform will promote multicenter collaboration, enhance VAP surveillance, and improve NICU quality.
Certified and interactive online course on the Moodle platform for training healthcare professionals in standardized diagnosis and prevention of neonatal VAP. [15 months.]: Based on the literature, training materials will be developed to unify diagnostic criteria and establish evidence-based preventive guidelines. The course will feature modules on neonatal VAP definition and epidemiology, consensus diagnostic criteria (clinical, radiological, and microbiological), and evidence-based preventive measures such as hand hygiene, ventilator care, patient positioning, and weaning. Additional topics include implementation, data recording, and quality monitoring. The platform will offer multimedia, forums, protocols, and certification assessments, with expert validation, instructional design, pilot testing, and ongoing refinement. Participants get methodological and technical support throughout the one-month course and indefinite access to materials and forums. Seven editions will be held to ensure full staff training at all participating centers.
To provide information and training on the use of telescoping catheter techniques for diagnostic purposes. [15 months.]: In addition to unifying diagnostic criteria and implementing preventive measures, training in microbiological diagnosis using the telescoping catheter constitutes a specific component integrated into the project's training program. This technique is currently considered the most suitable for ensuring accurate diagnosis and demonstrates greater sensitivity compared to other more widely used methods. This component is addressed within the online course through a detailed video tutorial, a standardized protocol, and an infographic highlighting key concepts. Adoption of this technique in routine practice by hospitals (in cases where it was not previously implemented) will be evaluated through data reported in the Neo-NAV registry system.
. 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.]: Every four months, collaborating investigators from participating centers will enter standardized data on adherence to and effectiveness of preventive bundles, including hand hygiene, ventilator circuit care, endotracheal tube management, patient positioning, among others. At the initial meeting, before the start of training, centers will register all VAP preventive measures in use and provide information on the existing protocols for intubation, extubation, and cleaning practices. In subsequent meetings, centers will update the platform with any changes implemented. This process will allow monitoring of practice modifications and their impact on recorded episodes of pneumonia.
Standardization of a definition of VAP in neonates. [6 months.]: Diagnostic practices for VAP in neonates will be systematically documented across participating hospitals during the pre-intervention phase. This process will include recording, via the Neo-NAV platform, the application and frequency of clinical, radiological, and/or microbiological criteria routinely used for diagnosis, as well as collecting complementary information through specifically designed surveys. This will establish a baseline reference against which future interventions aimed at diagnostic standardization and improvement can be evaluated, and will also allow characterization of inter-institutional variability in diagnostic approaches and concordance among criteria applied.
Collection and analysis of antibiotic use data in the treatment of neonatal VAP. [28 months.]: This system will record both empirical and definitive antibiotic therapies prescribed for suspected VAP, including the drug administered and treatment duration while the patient remains under invasive mechanical ventilation (IMV). In addition, all antibiotic therapies administered during IMV for infections not related to VAP will be documented.

+Eligibility

Sex: All, ages: 0 Days to 6 Months

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

+Locations (39)

Facility	City	Country	Status
Hospital Universitario de A Coruña	A Coruña, A Coruña	Spain	Recruiting
Hospital Clínico Universitario de Santiago	Santiago de Compostela, A Coruña	Spain	Not yet recruiting
Complejo Hospitalario Universitario de Albacete	Albacete, Albacete	Spain	Recruiting
Hospital Universitario Germans Trias i Pujol	Badalona, Barcelona	Spain	Recruiting
Hospital de la Santa Creu i Sant Pau	Barcelona, Barcelona	Spain	Recruiting
Hospital Universitario Vall d'Hebrón	Barcelona, Barcelona	Spain	Recruiting
Hospital Universitario de Cruces	Barakaldo, Bizkaia	Spain	Recruiting
Hospital Universitario de Basurto	Bilbao, Bizkaia	Spain	Recruiting
Hospital Universitario de Burgos (HUBU)	Burgos, Burgos	Spain	Recruiting
Hospital San Pedro de Alcántara	Cáceres, Caceres	Spain	Recruiting
Hospital Universitario Puerta del Mar	Cadiz, Cadiz	Spain	Recruiting
Hospital Universitario De Jerez	Jerez de la Frontera, Cadiz	Spain	Recruiting
Hospital Universitario Marqués de Valdecilla	Santander, Cantabria	Spain	Recruiting
Hospital Universitario de Donostia	Donostia / San Sebastian, Gipuzkoa	Spain	Recruiting
Hospital Universitario Virgen de las Nieves	Granada, Granada	Spain	Recruiting
Complejo Hospitalario de Jaén	Jaén, Jaen	Spain	Recruiting
Hospital Materno Infantil de Gran Canaria	Las Palmas de Gran Canaria, Las Palmas	Spain	Recruiting
Hospital Universitario de León	León, Leon	Spain	Recruiting
Hospital Universitario Arnau de Vilanova	Lleida, Lleida	Spain	Recruiting
Hospital Universitario HM Monteprincipe	Boadilla del Monte, Madrid	Spain	Recruiting
Hospital General Universitario Gregorio Marañón	Madrid, Madrid	Spain	Recruiting
Clínica Universidad de Navarra	Madrid, Madrid	Spain	Not yet recruiting
Hospital Universitario 12 de Octubre	Madrid, Madrid	Spain	Recruiting
Hospital Universitario La Paz	Madrid, Madrid	Spain	Recruiting
Hospital Regional Universitario de Málaga	Málaga, Malaga	Spain	Recruiting
Hospital General Universitario Santa Lucía	Cartagena, Murcia	Spain	Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca	Murcia, Murcia	Spain	Not yet recruiting
Clínica Universidad de Navarra - Hospital	Pamplona, Navarre	Spain	Not yet recruiting
Hospital Universitario de Navarra	Pamplona, Navarre	Spain	Recruiting
Complejo Hospitalario Universitario de Pontevedra	Pontevedra, Pontevedra	Spain	Recruiting
Hospital Universitario Central de Asturias	Oviedo, Principality of Asturias	Spain	Recruiting
Hospital Clínico Universitario de Salamanca	Salamanca, Salamanca	Spain	Recruiting
Hospital Universitario Virgen del Rocío	Seville, Sevilla	Spain	Recruiting
Hospital Universitario Nuestra Señora de Valme	Seville, Sevilla	Spain	Recruiting
Hospital General Universitario de Castellón	Castellon, Valencia	Spain	Recruiting
Hospital Clinico Universitario de Valencia	Valencia, Valencia	Spain	Recruiting
Hospital Universitario y Politécnico La Fe	Valencia, Valencia	Spain	Recruiting
Hospital Universitario Río Hortega	Valladolid, Valladolid	Spain	Recruiting
Hospital Universitario Materno Infantil Miguel Servet	Zaragoza, Zaragoza	Spain	Recruiting

+Publications

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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
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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
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+Investigators

Maria Cruz Lopez Herrera, Study director, Biobizkaia Health Research Institute