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

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Behavioral, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.

Locations
Other Locations
Spain
Hospital Universitario de A Coruña
RECRUITING
A Coruña
Complejo Hospitalario Universitario de Albacete
RECRUITING
Albacete
Hospital Universitario Germans Trias i Pujol
RECRUITING
Badalona
Hospital Universitario de Cruces
RECRUITING
Barakaldo
Hospital de la Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebrón
RECRUITING
Barcelona
Hospital Universitario de Basurto
RECRUITING
Bilbao
Hospital Universitario HM Monteprincipe
RECRUITING
Boadilla Del Monte
Hospital Universitario de Burgos (HUBU)
RECRUITING
Burgos
Hospital San Pedro de Alcántara
RECRUITING
Cáceres
Hospital Universitario Puerta del Mar
RECRUITING
Cadiz
Hospital General Universitario Santa Lucía
NOT_YET_RECRUITING
Cartagena
Hospital General Universitario de Castellón
RECRUITING
Castellon
Hospital Universitario de Donostia
RECRUITING
Donostia / San Sebastian
Hospital Universitario Virgen de las Nieves
RECRUITING
Granada
Complejo Hospitalario de Jaén
RECRUITING
Jaén
Hospital Universitario De Jerez
RECRUITING
Jerez De La Frontera
Hospital Materno Infantil de Gran Canaria
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario de León
RECRUITING
León
Hospital Universitario Arnau de Vilanova
RECRUITING
Lleida
Clínica Universidad de Navarra
NOT_YET_RECRUITING
Madrid
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital Clínico Universitario Virgen de la Arrixaca
NOT_YET_RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
Clínica Universidad de Navarra - Hospital
NOT_YET_RECRUITING
Pamplona
Hospital Universitario de Navarra
RECRUITING
Pamplona
Complejo Hospitalario Universitario de Pontevedra
RECRUITING
Pontevedra
Hospital Clínico Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario Marqués de Valdecilla
RECRUITING
Santander
Hospital Clínico Universitario de Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Hospital Universitario Nuestra Señora de Valme
RECRUITING
Seville
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Clinico Universitario de Valencia
RECRUITING
Valencia
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Hospital Universitario Río Hortega
RECRUITING
Valladolid
Hospital Universitario Materno Infantil Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Patricia Sanchez Hernandez
patricia.sanchezhernandez@bio-bizkaia.eus
946006136
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 1500
Treatments
Patients admitted to participating NICUs who require mechanical ventilation
Related Therapeutic Areas
Sponsors
Collaborators: Instituto de Investigacion Sanitaria La Fe, Clinica Universidad de Navarra, Universidad de Navarra, Hospital Universitario 12 de Octubre, Hospital Universitario La Fe, European Union, Hospital Arnau de Vilanova, Hospital Universitario La Paz, Red Salud Materno Infantil y del Desarrollo, Carlos III Health Institute, Hospital Universitario Puerta del Mar, Hospital Clinico Universitario de Santiago, Hospital Materno-Infantil de Málaga, Hospital de Basurto, Hospital General Universitario Santa Lucía, University Hospital Virgen de las Nieves, Hospital Universitario Virgen de la Arrixaca, Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain, Hospital Universitario de Jerez de la Frontera, Hospital of Navarra, Hospital Donostia, Complexo Hospitalario Universitario de A Coruña, Complejo Hospitalario de Jaen, Hospital Universitario Marqués de Valdecilla, Hospital HM Montepríncipe, Hospital Universitario de Burgos, Hospital Clínico Universitario de Valencia, Hospital Universitario Virgen del Rocio, Hospital Universitario Central de Asturias, Complejo Hospitalario Universitario de Pontevedra, Hospital General Universitario Gregorio Marañon, Hospital Universitari de la Vall de Hebron, Hospital San Pedro de Alcantara, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital del Rio Hortega, Salamanca University Hospital, Hospital General Universitario de Castellón, Germans Trias i Pujol Hospital
Leads: Biobizkaia Health Research Institute

This content was sourced from clinicaltrials.gov

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