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

November 19, 2025 updated by: Maria Cruz López Herrera, Biocruces Bizkaia Health Research Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • A Coruña
      • A Coruña, A Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario de A Coruna
        • Contact:
        • Principal Investigator:
          • Soledad Martinez Regueira
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Not yet recruiting
        • Hospital Clinico Universitario de Santiago
        • Contact:
        • Principal Investigator:
          • Ana M Baña Souto
    • Albacete
      • Albacete, Albacete, Spain, 02006
        • Recruiting
        • Complejo Hospitalario Universitario de Albacete
        • Contact:
        • Principal Investigator:
          • Nelia Navarro Patiño
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitario Germans Trias i Pujol
        • Contact:
        • Principal Investigator:
          • Ana Vinaixa Verges
      • Barcelona, Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Fatima Camba Longueira
      • Barcelona, Barcelona, Spain, 08025
        • Recruiting
        • Hospital De La Santa Creu I Sant Pau
        • Contact:
        • Principal Investigator:
          • Elisenda Moliner Calderon
    • Bizkaia
      • Barakaldo, Bizkaia, Spain, 48903
        • Recruiting
        • Hospital Universitario de Cruces
        • Contact:
        • Principal Investigator:
          • Fernando Martin Birlanga
        • Principal Investigator:
          • Maria Cruz Lopez Herrera
        • Sub-Investigator:
          • Patricia Sanchez Hernandez
      • Bilbao, Bizkaia, Spain, 48013
        • Recruiting
        • Hospital Universitario de Basurto
        • Contact:
        • Principal Investigator:
          • Ainhoa Aguirre Conde
    • Burgos
      • Burgos, Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos (HUBU)
        • Contact:
        • Principal Investigator:
          • Maria Miranda Vega
    • Caceres
      • Cáceres, Caceres, Spain, 10003
        • Recruiting
        • Hospital San Pedro de Alcantara
        • Contact:
        • Principal Investigator:
          • Rebeca Martinez Fernandez
    • Cadiz
      • Cadiz, Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta del Mar
        • Contact:
        • Principal Investigator:
          • Paula Mendez Abad
      • Jerez de la Frontera, Cadiz, Spain, 11407
        • Recruiting
        • Hospital Universitario de Jerez
        • Contact:
        • Principal Investigator:
          • Patricia Martin Cendon
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
        • Principal Investigator:
          • Andrea Gutierrez Camus
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
        • Contact:
        • Principal Investigator:
          • Raquel Mendiola Ruiz
    • Granada
      • Granada, Granada, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de Las Nieves
        • Contact:
        • Principal Investigator:
          • Laura Serrano Lopez
    • Jaen
      • Jaén, Jaen, Spain, 23007
        • Recruiting
        • Complejo Hospitalario de Jaen
        • Contact:
        • Principal Investigator:
          • Beatriz Jimenez Jurado
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Recruiting
        • Hospital Materno Infantil de Gran Canaria
        • Contact:
        • Principal Investigator:
          • Pedro J Cabrera Vega
    • Leon
      • León, Leon, Spain, 24008
        • Recruiting
        • Hospital Universitario de León
        • Contact:
        • Principal Investigator:
          • Sandra Terroba Seara
    • Lleida
      • Lleida, Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitario Arnau de Vilanova
        • Contact:
        • Principal Investigator:
          • Eduard Sole Mir
    • Madrid
      • Boadilla del Monte, Madrid, Spain, 28660
        • Recruiting
        • Hospital Universitario HM Monteprincipe
        • Contact:
        • Principal Investigator:
          • Gerardo Romera Modamio
      • Madrid, Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
        • Principal Investigator:
          • Elena Bergon Sendin
      • Madrid, Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Principal Investigator:
          • Laura Sanchez Garcia
      • Madrid, Madrid, Spain, 28007
        • Recruiting
        • Hospital General Universitario Gregorio Marañon
        • Contact:
        • Principal Investigator:
          • Maria Elena Zamora Flores
      • Madrid, Madrid, Spain, 28027
        • Not yet recruiting
        • Clinica Universidad de Navarra
        • Contact:
          • Felipe Garrido Martinez de Salazar
          • Phone Number: 661214947
          • Email: fgarridom@unav.es
        • Principal Investigator:
          • Felipe Garrido Martinez de Salazar
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Recruiting
        • Hospital Regional Universitario de Malaga
        • Contact:
        • Principal Investigator:
          • Maria Gonzalez Lopez
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Not yet recruiting
        • Hospital General Universitario Santa Lucía
        • Contact:
        • Principal Investigator:
          • Jose Ramon Fernandez Fructuoso
      • Murcia, Murcia, Spain, 30120
        • Not yet recruiting
        • Hospital Clinico Universitario Virgen de la Arrixaca
        • Contact:
        • Principal Investigator:
          • Olga Micol Martinez
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
        • Contact:
        • Principal Investigator:
          • Asier Oliver Olid
      • Pamplona, Navarre, Spain, 31008
        • Not yet recruiting
        • Clínica Universidad de Navarra - Hospital
        • Contact:
        • Principal Investigator:
          • Monica Riaza Gomez
    • Pontevedra
      • Pontevedra, Pontevedra, Spain, 36161
        • Recruiting
        • Complejo Hospitalario Universitario de Pontevedra
        • Contact:
        • Principal Investigator:
          • Maria de los Angeles Martinez Fernandez
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Rosa P Arias Llorente
    • Salamanca
      • Salamanca, Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clinico Universitario de Salamanca
        • Contact:
        • Principal Investigator:
          • Ruben Garcia Sanchez
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Marta Gonzalez Fernandez-Palacios
      • Seville, Sevilla, Spain, 41014
        • Recruiting
        • Hospital Universitario Nuestra Señora de Valme
        • Contact:
        • Principal Investigator:
          • Rocio Rodero Prieto
    • Valencia
      • Castellon, Valencia, Spain, 12004
        • Recruiting
        • Hospital General Universitario de Castellon
        • Contact:
        • Principal Investigator:
          • Cristina Barreira Barreal
      • Valencia, Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Elena Cubells Garcia
      • Valencia, Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
        • Contact:
        • Principal Investigator:
          • Ana Gimeno Navarro
        • Sub-Investigator:
          • María Cernada Badía
        • Sub-Investigator:
          • Alejandro Pinilla González
    • Valladolid
      • Valladolid, Valladolid, Spain, 47012
        • Recruiting
        • Hospital Universitario Rio Hortega
        • Contact:
        • Principal Investigator:
          • Maria del Mar Montejo Vicente
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitario Materno Infantil Miguel Servet
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zenaida Galve Pradel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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 test: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocruces Bizkaia Health Research Institute

Collaborators

Hospital General Universitario Gregorio Marañon
Germans Trias i Pujol Hospital
Hospital Arnau de Vilanova
Hospital Donostia
Salamanca University Hospital
Carlos III Health Institute
Hospital de Basurto
Instituto de Investigacion Sanitaria La Fe
Clinica Universidad de Navarra, Universidad de Navarra
Hospital Universitario Virgen de la Arrixaca
Hospital Universitario 12 de Octubre
Hospital Universitario La Fe
European Union
Hospital General Universitario Santa Lucia
Hospital Universitario La Paz
Hospital del Rio Hortega
Hospital Universitario Central de Asturias
Hospital Universitario Marqués de Valdecilla
Hospital San Pedro de Alcantara
Complexo Hospitalario Universitario de A Coruña
Hospital Clinico Universitario de Santiago
Hospital Universitari de la Vall de Hebron
Hospital Universitario Puerta del Mar
Hospital Universitario de Burgos
Hospital of Navarra
University Hospital Virgen de las Nieves
Hospital HM Montepríncipe
Hospital General Universitario de Castellón
Hospital Clínico Universitario de Valencia
Hospital Materno-Infantil de Málaga
Complejo Hospitalario Universitario de Pontevedra
Complejo Hospitalario de Jaen
Red Salud Materno Infantil y del Desarrollo
Hospital de la Santa creu i Sant Pau - Barcelona
Hospital Universitario Virgen del Rocio
Hospital Universitario de Jerez de la Frontera
Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain

Investigators

  • Study Director: Maria Cruz Lopez Herrera, Biocruces Bizkaia Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

November 19, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INBERNAV-Neo-21/01513
  • PI2024002 (Other Identifier: CEIm Euskadi)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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