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RECRUITING
NCT07240038

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

Sponsor: Biobizkaia Health Research Institute

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

0 Days - 6 Months

Study Type

OBSERVATIONAL

Enrollment

1500

Start Date

2024-04-26

Completion Date

2026-06-30

Last Updated

2025-11-20

Healthy Volunteers

No

Interventions

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.

Bibliographical search and analysis to identify and prioritize effective and feasible interventions and procedures. Consensus among professionals for its adaptation to our Healthcare System. Areas of intervention: Hand hygiene: before and after patient contact and handling of respiratory equipment. Intubation: new and sterile ETT every intubation attempt; no contact with any non-sterile surface before insertion; avoid reintubation; ≥ two professionals. Suctioning: obstruction or increased respiratory secretions, never routinely. Two professional. Double suction system: one for oral cavity and one for airway, both connected to a closed suction system. Prior to ETT manipulation, patient repositioning, extubation or reintubation. Feeding: adjust to avoid large debris and/or distension. Positioning: lateral decubitus; head 15-30°; lateral left after feeding. Oral care: Sterile water or breast milk before intubation; every 4 h and before orogastric tube insertion. .

DIAGNOSTIC_TEST

Technique with a blind-protected catheter

Through the use of an invasive technique with a blind-protected catheter, the possibility of contamination and the incidence of polymicrobial etiology is reduced, resulting in a sensitive and accurate diagnosis. The method employed in this study has previously been shown to be feasible, reproducible, safe, and comparable to bronchoscopic methods for identifying VAP in children, providing sterile access to the lower respiratory tract.

Locations (39)

Hospital Universitario de A Coruña

A Coruña, A Coruña, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, Spain

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario Vall d'Hebrón

Barcelona, Barcelona, Spain

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain

Hospital Universitario de Basurto

Bilbao, Bizkaia, Spain

Hospital Universitario de Burgos (HUBU)

Burgos, Burgos, Spain

Hospital San Pedro de Alcántara

Cáceres, Caceres, Spain

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, Spain

Hospital Universitario De Jerez

Jerez de la Frontera, Cadiz, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Donostia

Donostia / San Sebastian, Gipuzkoa, Spain

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain

Complejo Hospitalario de Jaén

Jaén, Jaen, Spain

Hospital Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario de León

León, Leon, Spain

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, Spain

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain

Clínica Universidad de Navarra

Madrid, Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Malaga, Spain

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain

Clínica Universidad de Navarra - Hospital

Pamplona, Navarre, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Pontevedra, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Universitario Nuestra Señora de Valme

Seville, Sevilla, Spain

Hospital General Universitario de Castellón

Castellon, Valencia, Spain

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain

Hospital Universitario Materno Infantil Miguel Servet

Zaragoza, Zaragoza, Spain