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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Days to 6 Months |
| Sex | All |
| Enrollment | 1500 (estimated) |
| Sponsor | Biobizkaia Health Research Institute Government |
| Locations | 39 sites (A Coruña, A Coruña and 38 other locations) |
| Status | Recruiting |
| Started | April 26, 2024 |
| Main results expected | December 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT07240038 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
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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
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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
- Study coordinator: Patricia Sanchez Hernandez
- Email: patricia.sanchezhernandez@bio-bizkaia.eus
- Phone: 946006136
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Predicting which newborns in a lower-level NICU will need extended breathing support
This project will test whether analyzing a newborn's stomach fluid right after birth can help predict which babies born at 32+ weeks and attended by the neonatal resuscitation team will need breathing support for more than six hours.
-
Ventilator-associated pneumonia rates and use of SRLF 2017 diagnostic rules in an ICU (2022–2024)
This project will look at respiratory samples from adults on mechanical ventilation in a regional ICU to see if doctors followed the SRLF 2017 rules when diagnosing ventilator-associated pneumonia between 2022 and 2024.
-
Antibiotic approaches for Stenotrophomonas maltophilia pneumonia in ICU patients
This study tests whether using one antibiotic versus two, and whether treating for 7 days versus 14 days, helps adults on ventilators in the ICU with Stenotrophomonas maltophilia pneumonia survive and avoid recurrence.
-
Program to improve hand hygiene and reduce infections in hospitals
This study tests if having special nurses help hospital staff follow hand hygiene rules can lower infection rates in patients.
-
Examining immunity markers in ICU patients with ventilator-associated pneumonia
This study is trying to see if measuring certain immune markers in ICU patients with ventilator-associated pneumonia can help improve their treatment and outcomes.
-
Using sequencing to predict outcomes of pneumonia in ventilated patients
This study is testing if analyzing germs in the lungs of patients on ventilators can help predict how well they will recover from pneumonia.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.