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Reducing ventilator-associated pneumonia in newborns in the NICU

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

Biobizkaia Health Research Institute · NCT07240038

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 typeObservational
Enrollment1500 (estimated)
Ages0 Days to 6 Months
SexAll
SponsorBiobizkaia Health Research Institute (other gov)
Locations39 sites (A Coruña, A Coruña and 38 other locations)
Trial IDNCT07240038 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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 performed: 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.

Eligibility criteria

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 this trial is running

A Coruña, A Coruña and 38 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Pneumonia Ventilator Associated, Pneumonia Neonatal, Healthcare-associated Infections, neonate, ventilator-associated pneumonia, quasi-experimental, multicenter, prevention

Last reviewed 2026-05-15 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.