Pneumonia Ventilator AssociatedINBERNAV-NeoNCT07240038
Reduction of the Incidence of NAV in Neonatal Units (INBERNAV-Neo)
An observational study of Pneumonia Ventilator Associated and Pneumonia Neonatal, run by Biobizkaia Health Research Institute at 39 sites in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 0 days to 6 months
- Conditions the study is for
- Pneumonia Ventilator Associated, Pneumonia Neonatal, Healthcare-associated Infections
- What is being tested?
- 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. and Technique with a blind-protected catheter
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 1,500 participants
- Where
- 39 sitesSpain
- Study dates
- 26 Apr 2024to 30 Jun 2026
- How long will I take part?
- 365 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 6 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.
Who cannot join
- 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 locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
Spain39 sites, 39 recruiting
- Recruiting
Hospital Universitario de A Coruña
A Coruña, A Coruña, 15006
Soledad Martinez Regueira, 605115360, soledad.martinez.regueira@sergas.es
Soledad Martinez Regueira
- Recruiting
Complejo Hospitalario Universitario de Albacete
Albacete, Albacete, 02006
Nelia Navarro Patiño, 653989961, nnavarropatino@gmail.com
Nelia Navarro Patiño
- Recruiting
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, 08916
Anna Vinaixa Verges, 625571812, avinaixave.germanstrias@gencat.cat
Ana Vinaixa Verges
- Recruiting
Hospital Universitario de Cruces
Barakaldo, Bizkaia, 48903
Patricia Sánchez Hernández, 946006136 ext. 846136, patricia.sanchezhernandez@bio-bizkaia.eus
Fernando Martin Birlanga
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
Elisenda Moliner Calderon, 629813811, emoliner@santpau.cat
Elisenda Moliner Calderon
- Recruiting
Hospital Universitario Vall d'Hebrón
Barcelona, Barcelona, 08035
Fatima Camba Longueira, 652227847, fatima.camba@vallhebron.cat
Fatima Camba Longueira
- Recruiting
Hospital Universitario de Basurto
Bilbao, Bizkaia, 48013
Ainhoa Aguirre Conde, 620246923, ainhoa.aguirreconde@osakidetza.eus
Ainhoa Aguirre Conde
- Recruiting
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, 28660
Gerardo Romera Modamio, 917089900 ext. 2527, gromera@hmhospitales.com
Gerardo Romera Modamio
- Recruiting
Hospital Universitario de Burgos (HUBU)
Burgos, Burgos, 09006
Maria Miranda Vega, 980669126, mmirandav@saludcastillayleon.es
Maria Miranda Vega
- Recruiting
Hospital San Pedro de Alcántara
Cáceres, Caceres, 10003
Rebeca Martinez Fernandez, 699526582, rebecamartinfdz@hotmail.com
Rebeca Martinez Fernandez
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz, Cadiz, 11009
Paula Mendez Abad, 600857981, pmendezab@gmail.com
Paula Mendez Abad
- Not yet recruiting
Hospital General Universitario Santa Lucía
Cartagena, Murcia, 30202
Jose Ramon Fernandez Fructuoso, 968128600, joser.fernandez3@carm.es
Jose Ramon Fernandez Fructuoso
- Recruiting
Hospital General Universitario de Castellón
Castellon, Valencia, 12004
Cristina Barreira Barreal, 697367686, crisbarreirab@gmail.com
Cristina Barreira Barreal
- Recruiting
Hospital Universitario de Donostia
Donostia / San Sebastian, Gipuzkoa, 20014
Raquel Mendiola Ruiz, 943003417, raquel.mendiolaruiz@osakidetza.eus
Raquel Mendiola Ruiz
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18014
Laura Serrano Lopez, 958020153, lserranolopez@hotmail.com
Laura Serrano Lopez
- Recruiting
Complejo Hospitalario de Jaén
Jaén, Jaen, 23007
Beatriz Jimenez Jurado, v, bea_91_@hotmail.com
Beatriz Jimenez Jurado
- Recruiting
Hospital Universitario De Jerez
Jerez de la Frontera, Cadiz, 11407
Patricia Martin Cendon, 696780496, patriciamcendon@yahoo.es
Patricia Martin Cendon
- Recruiting
Hospital Materno Infantil de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016
Pedro J Cabrera Vega, 680441985, pedro.cv.1988@gmail.com
Pedro J Cabrera Vega
- Recruiting
Hospital Universitario de León
León, Leon, 24008
Sandra Terroba Seara, 987237400 ext. 42252, sterroba@saludcastillayleon.es
Sandra Terroba Seara
- Recruiting
Hospital Universitario Arnau de Vilanova
Lleida, Lleida, 25198
Eduard Sole Mir, 696404168, esolem.lleida.ics@gencat.cat
Eduard Sole Mir
- Recruiting
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007
Maria Elena Zamora Flores, 915290018, zamoraflores@hotmail.com
Maria Elena Zamora Flores
- Not yet recruiting
Clínica Universidad de Navarra
Madrid, Madrid, 28027
Felipe Garrido Martinez de Salazar, 661214947, fgarridom@unav.es
Felipe Garrido Martinez de Salazar
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Elena Bergon Sendin, 913908272, ebergon@hotmail.com
Elena Bergon Sendin
- Recruiting
Hospital Universitario La Paz
Madrid, Madrid, 28046
Laura Sanchez Garcia, 686285729, laurasg_alcobendas@yahoo.es
Laura Sanchez Garcia
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, Malaga, 29010
Maria Gonzalez Lopez, 951950444, margonlop@hotmail.com
Maria Gonzalez Lopez
- Not yet recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, 30120
Olga Micol Martínez, 637261988, olgamicolmartinez21@gmail.com
Olga Micol Martinez
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Rosa P Arias Llorente, 985108000 ext. 37509, soyrosapatricia@hotmail.com
Rosa P Arias Llorente
- Not yet recruiting
Clínica Universidad de Navarra - Hospital
Pamplona, Navarre, 31008
Monica Riaza Gomez, 918199485, mriazagomez@unav.es
Monica Riaza Gomez
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Asier Oliver Olid, 848422222, asieroliver@gmail.com
Asier Oliver Olid
- Recruiting
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, Pontevedra, 36161
Maria de los Angeles Martinez Fernandez, 986807095, mariapantin@mundo-r.com
Maria de los Angeles Martinez Fernandez
- Recruiting
Hospital Clínico Universitario de Salamanca
Salamanca, Salamanca, 37007
Ruben Garcia Sanchez, 650272451, rubennigue@hotmail.com
Ruben Garcia Sanchez
- Recruiting
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Andrea Gutierrez Camus, 676848891, andrea.gutierrez@scsalud.es
Andrea Gutierrez Camus
- Not yet recruiting
Hospital Clínico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706
Ana M Baña Souto, 615316970, anamariabana@gmail.com
Ana M Baña Souto
- Recruiting
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Marta Gonzalez Fernandez-Palacios, 687657842, martagfp86@gmail.com
Marta Gonzalez Fernandez-Palacios
- Recruiting
Hospital Universitario Nuestra Señora de Valme
Seville, Sevilla, 41014
Rocio Rodero Prieto, 635241769, ro.roderop@gmail.com
Rocio Rodero Prieto
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, Valencia, 46010
Elena Cubells Garcia, 962051230, cubecha@hotmail.com
Elena Cubells Garcia
- Recruiting
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Maria Cernada Badía, 656541337, mariacernada@gmail.com
Ana Gimeno Navarro
- Recruiting
Hospital Universitario Río Hortega
Valladolid, Valladolid, 47012
Maria del Mar Montejo Vicente, 626815799, mmonvic@hotmail.com
Maria del Mar Montejo Vicente
- Recruiting
Hospital Universitario Materno Infantil Miguel Servet
Zaragoza, Zaragoza, 50009
Zenaida Galve Pradel, 976765500 ext. 3240, zenagalve@yahoo.es
zenagalve@yahoo.es
About this study
Official title: 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.
- Being tested
- 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
- Keywords
- neonate, ventilator-associated pneumonia, quasi-experimental, multicenter, prevention, epidemiologic surveillance, clinical diagnosis, microbiological diagnostics, NICU, intervention, good clinical practice, patient safety
- Medical subject headings
- Pneumonia, Ventilator-Associated, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Behavioural
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 catheterDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Patients admitted to participating NICUs who require mechanical ventilation | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the initiation of IMV until extubation plus an additional 2 days of monitoring in some cases.
Secondary outcomes (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.
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.
Measured: 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.
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.
Measured: 28 months.
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.
Measured: 15 months.
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.
Measured: 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.
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.
Measured: Every 4 months during a 20-month period.
Standardization of a definition of VAP in neonates.
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.
Measured: 6 months.
Collection and analysis of antibiotic use data in the treatment of neonatal VAP.
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.
Measured: 28 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start26 Apr 2024
- Primary completionDec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (57)Papers the sponsor has linked to this study.
- Other trials for Pneumonia Ventilator AssociatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 365 Days
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- 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
- Responsible party
- Principal investigator, Maria Cruz López Herrera, Biobizkaia Health Research Institute
- Investigators
- Maria Cruz Lopez Herrera, Study director, Biobizkaia Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07240038
- Sponsor's protocol ID
- INBERNAV-Neo-21/01513
- Other IDs
- PI2024002
- Acronym
- INBERNAV-Neo
- Status last verified
- Nov 2025
- First submitted
- 17 Jun 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30842077Williams 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.
PubMed 35523885WHO 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/
PubMed 23805438Wang 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.
PubMed 31675354Wang 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.
PubMed 33143219van 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.
PubMed 34534162Tusor 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.
PubMed 32592026Thibeau 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.
PubMed 23722491Thatrimontrichai A, Rujeerapaiboon N, Janjindamai W, Dissaneevate S, Maneenil G, Kritsaneepaiboon S, Tanaanantarak P. Outcomes and risk factors of ventilator-associated pneumonia in neonates. World J Pediatr. 2017 Aug;13(4):328-334. doi: 10.1007/s12519-017-0010-0. Epub 2017 Jan 25.
PubMed 28120236Tan B, Zhang F, Zhang X, Huang YL, Gao YS, Liu X, Li YL, Qiu JF. Risk factors for ventilator-associated pneumonia in the neonatal intensive care unit: a meta-analysis of observational studies. Eur J Pediatr. 2014 Apr;173(4):427-34. doi: 10.1007/s00431-014-2278-6. Epub 2014 Feb 13.
PubMed 24522325Ryan RM, Wilding GE, Wynn RJ, Welliver RC, Holm BA, Leach CL. Effect of enhanced ultraviolet germicidal irradiation in the heating ventilation and air conditioning system on ventilator-associated pneumonia in a neonatal intensive care unit. J Perinatol. 2011 Sep;31(9):607-14. doi: 10.1038/jp.2011.16. Epub 2011 Mar 24.
PubMed 21436785Rosenthal VD, Alvarez-Moreno C, Villamil-Gomez W, Singh S, Ramachandran B, Navoa-Ng JA, Duenas L, Yalcin AN, Ersoz G, Menco A, Arrieta P, Bran-de Casares AC, de Jesus Machuca L, Radhakrishnan K, Villanueva VD, Tolentino MC, Turhan O, Keskin S, Gumus E, Dursun O, Kaya A, Kuyucu N. Effectiveness of a multidimensional approach to reduce ventilator-associated pneumonia in pediatric intensive care units of 5 developing countries: International Nosocomial Infection Control Consortium findings. Am J Infect Control. 2012 Aug;40(6):497-501. doi: 10.1016/j.ajic.2011.08.005. Epub 2011 Nov 3.
PubMed 22054689Rosenthal VD, Al-Abdely HM, El-Kholy AA, AlKhawaja SAA, Leblebicioglu H, Mehta Y, Rai V, Hung NV, Kanj SS, Salama MF, Salgado-Yepez E, Elahi N, Morfin Otero R, Apisarnthanarak A, De Carvalho BM, Ider BE, Fisher D, Buenaflor MCSG, Petrov MM, Quesada-Mora AM, Zand F, Gurskis V, Anguseva T, Ikram A, Aguilar de Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di Silvestre G, Furova K, Ramos-Ortiz GY, Gamar Elanbya MO, Satari HI, Gupta U, Dendane T, Raka L, Guanche-Garcell H, Hu B, Padgett D, Jayatilleke K, Ben Jaballah N, Apostolopoulou E, Prudencio Leon WE, Sepulveda-Chavez A, Telechea HM, Trotter A, Alvarez-Moreno C, Kushner-Davalos L; Remaining authors. International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: Device-associated module. Am J Infect Control. 2016 Dec 1;44(12):1495-1504. doi: 10.1016/j.ajic.2016.08.007. Epub 2016 Oct 11.
PubMed 27742143Raycheva R, Rangelova V, Kevorkyan A. Cost Analysis for Patients with Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit. Healthcare (Basel). 2022 May 25;10(6):980. doi: 10.3390/healthcare10060980.
PubMed 35742032Ramirez-Estrada S, Pena-Lopez Y, Vieceli T, Rello J. Ventilator-associated events: From surveillance to optimizing management. J Intensive Med. 2022 Nov 12;3(3):204-211. doi: 10.1016/j.jointm.2022.09.004. eCollection 2023 Jul 31.
PubMed 37533808
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Evidence Based, Bundled Intervention to Reduce Incidence of Ventilator-associated Pneumonia in Neonatal Units (INBERNAV-Neo)
- ClinicalTrials.gov ID
- NCT07240038
- Acronym / sponsor ID
- INBERNAV-Neo / INBERNAV-Neo-21/01513
- Keywords
- neonate, ventilator-associated pneumonia, quasi-experimental, multicenter, prevention, epidemiologic surveillance, clinical diagnosis, microbiological diagnostics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- 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
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 365 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. . | Behavioural | Patients admitted to participating NICUs who require mechanical ventilation |
| Technique with a blind-protected catheterThrough 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. | Diagnostic test | Patients admitted to participating NICUs who require mechanical ventilation |
Primary outcome
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.
7 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.
Time frame: 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.
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.
To provide information and training on the use of telescoping catheter techniques for diagnostic purposes.
Time frame: 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.
Standardization of a definition of VAP in neonates.
Time frame: 6 months.
Collection and analysis of antibiotic use data in the treatment of neonatal VAP.
Time frame: 28 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 30842077Williams 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.
- Background: PubMed 35523885Williams 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.
- Background: PubMed 23805438WHO 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/
- Background: PubMed 31675354Wang 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.
- Background: PubMed 33143219Wang 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.
- Background: PubMed 34534162van 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.
- Background: PubMed 32592026Tusor 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.
- Background: PubMed 23722491Thibeau 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.
- Background: PubMed 28120236Thatrimontrichai A, Rujeerapaiboon N, Janjindamai W, Dissaneevate S, Maneenil G, Kritsaneepaiboon S, Tanaanantarak P. Outcomes and risk factors of ventilator-associated pneumonia in neonates. World J Pediatr. 2017 Aug;13(4):328-334. doi: 10.1007/s12519-017-0010-0. Epub 2017 Jan 25.
- Background: PubMed 24522325Tan B, Zhang F, Zhang X, Huang YL, Gao YS, Liu X, Li YL, Qiu JF. Risk factors for ventilator-associated pneumonia in the neonatal intensive care unit: a meta-analysis of observational studies. Eur J Pediatr. 2014 Apr;173(4):427-34. doi: 10.1007/s00431-014-2278-6. Epub 2014 Feb 13.
- Background: PubMed 21436785Ryan RM, Wilding GE, Wynn RJ, Welliver RC, Holm BA, Leach CL. Effect of enhanced ultraviolet germicidal irradiation in the heating ventilation and air conditioning system on ventilator-associated pneumonia in a neonatal intensive care unit. J Perinatol. 2011 Sep;31(9):607-14. doi: 10.1038/jp.2011.16. Epub 2011 Mar 24.
- Background: PubMed 22054689Rosenthal VD, Alvarez-Moreno C, Villamil-Gomez W, Singh S, Ramachandran B, Navoa-Ng JA, Duenas L, Yalcin AN, Ersoz G, Menco A, Arrieta P, Bran-de Casares AC, de Jesus Machuca L, Radhakrishnan K, Villanueva VD, Tolentino MC, Turhan O, Keskin S, Gumus E, Dursun O, Kaya A, Kuyucu N. Effectiveness of a multidimensional approach to reduce ventilator-associated pneumonia in pediatric intensive care units of 5 developing countries: International Nosocomial Infection Control Consortium findings. Am J Infect Control. 2012 Aug;40(6):497-501. doi: 10.1016/j.ajic.2011.08.005. Epub 2011 Nov 3.
- European Centre for Disease Prevention and Control. Hand hygiene (2015)Link provided by the sponsor.
- Ministerio de Sanidad. Seguridad del PacienteLink provided by the sponsor.
- Organización Mundial de la Salud. Report on the burden of endemic health care-associated infection worldwide. Geneva: World Health Organization (2011)Link provided by the sponsor.
- Osakidetza. Estrategia de Seguridad del Paciente 2030Link provided by the sponsor.
- World Health Organization, WHO Patient Safety. Hand hygiene technical reference manual: to be used by health-care workers, trainers and observers of hand hygiene practices (2009)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Cruz Lopez Herrera study director
Biobizkaia Health Research Institute
39 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia Ventilator Associated and Pneumonia Neonatal, run by Biobizkaia Health Research Institute at 39 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Sanchez Hernandez (946006136 ext. 846136, patricia.sanchezhernandez@bio-bizkaia.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07240038, which also lists 57 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.