Reduction of the Incidence of NAV 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.

NCT Number	NCT07240038
Lead Sponsor	Biobizkaia Health Research Institute 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
Conditions	Pneumonia Ventilator Associated, Pneumonia Neonatal, Healthcare-associated Infections
Enrollment	1,500 participants
Start Date	2024-04-26
Primary Completion	2025-12 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2025-11-20