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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorBiobizkaia Health Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patients from Spanish level III and II NICUs with an average annual incidence of at least 5 neonatal patients on invasive mechanical ventilation (IMV) for ≥ 48 hours, who agree to participate and form teams to implement the best practice bundles developed to improve the care of patients on IMV. The included patients will be admitted neonates requiring IMV, regardless of birth weight or gestational age.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

1,500 Participants
are divided into 1 treatment group
Group A: Patients admitted to participating NICUs who require mechanical ventilation2 interventions

Trial outcomes

Primary outcomes

1

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.

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

Secondary outcomes

1

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.

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.

Time frame
An initial literature collection period of 9 months, followed by continuous updates throughout 2 years.
2

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.

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.

Time frame
28 months.
3

Certified and interactive online course on the Moodle platform for training healthcare professionals in standardized diagnosis and prevention of neonatal VAP.

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.

Time frame
15 months.
4

To provide information and training on the use of telescoping catheter techniques for diagnostic purposes.

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.

Time frame
15 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biobizkaia Health Research Institute

Lead sponsor

Carlos III Health Institute

Collaborator

Instituto de Investigacion Sanitaria La Fe

Collaborator

European Union

Collaborator

Hospital Universitario 12 de Octubre

Collaborator

Hospital HM Montepríncipe

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Hospital Universitario La Paz

Collaborator

Clinica Universidad de Navarra, Universidad de Navarra

Collaborator

Hospital General Universitario de Castellón

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

Hospital Donostia

Collaborator

Hospital de Basurto

Collaborator

Complejo Hospitalario Universitario de Pontevedra

Collaborator

Hospital Universitario de Burgos

Collaborator

Hospital Clinico Universitario de Santiago

Collaborator

Hospital Universitari de la Vall de Hebron

Collaborator

Hospital of Navarra

Collaborator

Hospital San Pedro de Alcantara

Collaborator

Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain

Collaborator

Hospital Universitario Central de Asturias

Collaborator

Hospital Universitario Marqués de Valdecilla

Collaborator

Hospitales Universitarios Virgen del Rocío

Collaborator

Complejo Hospitalario de Jaen

Collaborator

Hospital Universitario Puerta del Mar

Collaborator

Hospital Universitario de Jerez de la Frontera

Collaborator

Hospital Materno-Infantil de Málaga

Collaborator

Hospital General Universitario Santa Lucía

Collaborator

Hospital Universitario Virgen de la Arrixaca

Collaborator

Hospital Universitario La Fe

Collaborator

Salamanca University Hospital

Collaborator

Complexo Hospitalario Universitario de A Coruña

Collaborator

Red Salud Materno Infantil y del Desarrollo

Collaborator

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator

University Hospital Virgen de las Nieves

Collaborator

Germans Trias i Pujol Hospital

Collaborator

Hospital del Rio Hortega

Collaborator

Hospital Arnau de Vilanova

Collaborator