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RECRUITINGOBSERVATIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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 (20)

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