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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07240038

Acronym

INBERNAV-Neo

Enrollment

1500

Registered

2025-11-20

Start date

2024-04-26

Completion date

2026-06-30

Last updated

2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthcare-associated Infections, Pneumonia Neonatal, Pneumonia Ventilator Associated

Keywords

neonate, ventilator-associated pneumonia, quasi-experimental, multicenter, prevention, epidemiologic surveillance, clinical diagnosis, microbiological diagnostics, NICU, intervention, good clinical practice, patient safety

Brief 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.

Interventions

BEHAVIORALMultimodal 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 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. .

DIAGNOSTIC_TESTTechnique 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 6 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.
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.
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.
. 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.

Countries

Spain

Contacts

Primary ContactPatricia Sanchez Hernandez

patricia.sanchezhernandez@bio-bizkaia.eus946006136

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026