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

Biocruces Bizkaia

Status: Enrolling

Conditions: Pneumonia Neonatal; Healthcare-associated Infections; Pneumonia Ventilator Associated

Treatments: 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

Study type: Observational

Funder types: Other

Identifiers

NCT07240038

INBERNAV-Neo-21/01513

PI2024002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 1,500 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

1,500 participants in 1 patient group

Patients admitted to participating NICUs who require mechanical ventilation

Treatment:

Diagnostic Test: Technique with a blind-protected catheter

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.