Clinical trial Recruiting at 34 sites Observational Ages 0 Days to 6 Months

Reducing ventilator-associated pneumonia in newborns in the NICU

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

Run by Biobizkaia Health Research Institute · NCT07240038 · Data updated 2026-11-12

This project will see if training NICU teams and using standardized care protocols can lower ventilator-associated pneumonia in babies on mechanical ventilation.

More Ventilator Associated Pneumonia trials

Quick facts

Study typeObservational
Ages0 Days to 6 Months
SexAll
Enrollment1500 (estimated)
SponsorBiobizkaia Health Research Institute
Government
Locations39 sites (A Coruña, A Coruña and 38 other locations)
StatusRecruiting
StartedApril 26, 2024
Main results expectedDecember 2025
Study endsJune 30, 2026
Registry record updatedNovember 20, 2025
Trial IDNCT07240038 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Neonates admitted to participating NICUs who remain on invasive mechanical ventilation for at least 48 hours are the intended participants.

Probably not a fit

Infants ventilated for less than 48 hours, those excluded by the treating clinician, or babies cared for outside participating centers are unlikely to benefit from this program.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The project implements a multicenter, quasi-experimental observational program to standardize definitions, diagnosis, and prevention of ventilator-associated pneumonia in neonatal intensive care units. Participating units receive training on a multimodal bundle of evidence-based practices (oral care, suctioning, patient positioning, protected catheter techniques, and related protocols). A prospective surveillance registry will collect demographic, clinical, and ventilation-related data for infants on invasive mechanical ventilation to measure incidence before and after the intervention. The aim is to harmonize practice across sites and measure whether the intervention reduces VAP frequency and impact.

Why it matters

Potential benefit: If successful, this could reduce the number of ventilator-associated pneumonia cases in NICU patients and standardize care to lower complications from infection.

How similar studies have gone: Multimodal prevention bundles have reduced ventilator-associated pneumonia in adult and pediatric ICUs and some neonatal quality-improvement projects report benefits, though neonatal-specific randomized data are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Hospital Universitario de A Coruña
    A Coruña, A Coruña, Spain
    Recruiting
  • Complejo Hospitalario Universitario de Albacete
    Albacete, Albacete, Spain
    Recruiting
  • Hospital Universitario Germans Trias i Pujol
    Badalona, Barcelona, Spain
    Recruiting
  • Hospital de la Santa Creu i Sant Pau
    Barcelona, Barcelona, Spain
    Recruiting
  • Hospital Universitario Vall d'Hebrón
    Barcelona, Barcelona, Spain
    Recruiting
  • Hospital Universitario de Cruces
    Barakaldo, Bizkaia, Spain
    Recruiting
Show 33 more locations
  • Hospital Universitario de Basurto
    Bilbao, Bizkaia, Spain
    Recruiting
  • Hospital Universitario de Burgos (HUBU)
    Burgos, Burgos, Spain
    Recruiting
  • Hospital San Pedro de Alcántara
    Cáceres, Caceres, Spain
    Recruiting
  • Hospital Universitario Puerta del Mar
    Cadiz, Cadiz, Spain
    Recruiting
  • Hospital Universitario De Jerez
    Jerez de la Frontera, Cadiz, Spain
    Recruiting
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria, Spain
    Recruiting
  • Hospital Universitario de Donostia
    Donostia / San Sebastian, Gipuzkoa, Spain
    Recruiting
  • Hospital Universitario Virgen de las Nieves
    Granada, Granada, Spain
    Recruiting
  • Complejo Hospitalario de Jaén
    Jaén, Jaen, Spain
    Recruiting
  • Hospital Materno Infantil de Gran Canaria
    Las Palmas de Gran Canaria, Las Palmas, Spain
    Recruiting
  • Hospital Universitario de León
    León, Leon, Spain
    Recruiting
  • Hospital Universitario Arnau de Vilanova
    Lleida, Lleida, Spain
    Recruiting
  • Hospital Universitario HM Monteprincipe
    Boadilla del Monte, Madrid, Spain
    Recruiting
  • Hospital General Universitario Gregorio Marañón
    Madrid, Madrid, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre
    Madrid, Madrid, Spain
    Recruiting
  • Hospital Universitario La Paz
    Madrid, Madrid, Spain
    Recruiting
  • Hospital Regional Universitario de Málaga
    Málaga, Malaga, Spain
    Recruiting
  • Hospital Universitario de Navarra
    Pamplona, Navarre, Spain
    Recruiting
  • Complejo Hospitalario Universitario de Pontevedra
    Pontevedra, Pontevedra, Spain
    Recruiting
  • Hospital Universitario Central de Asturias
    Oviedo, Principality of Asturias, Spain
    Recruiting
  • Hospital Clínico Universitario de Salamanca
    Salamanca, Salamanca, Spain
    Recruiting
  • Hospital Universitario Virgen del Rocío
    Seville, Sevilla, Spain
    Recruiting
  • Hospital Universitario Nuestra Señora de Valme
    Seville, Sevilla, Spain
    Recruiting
  • Hospital General Universitario de Castellón
    Castellon, Valencia, Spain
    Recruiting
  • Hospital Clinico Universitario de Valencia
    Valencia, Valencia, Spain
    Recruiting
  • Hospital Universitario y Politécnico La Fe
    Valencia, Valencia, Spain
    Recruiting
  • Hospital Universitario Río Hortega
    Valladolid, Valladolid, Spain
    Recruiting
  • Hospital Universitario Materno Infantil Miguel Servet
    Zaragoza, Zaragoza, Spain
    Recruiting
  • Hospital Clínico Universitario de Santiago
    Santiago de Compostela, A Coruña, Spain
    Not yet recruiting
  • Clínica Universidad de Navarra
    Madrid, Madrid, Spain
    Not yet recruiting
  • Hospital General Universitario Santa Lucía
    Cartagena, Murcia, Spain
    Not yet recruiting
  • Hospital Clínico Universitario Virgen de la Arrixaca
    Murcia, Murcia, Spain
    Not yet recruiting
  • Clínica Universidad de Navarra - Hospital
    Pamplona, Navarre, Spain
    Not yet recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.