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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-6
SponsorBiobizkaia Health Research Institute

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Treatments tested in this trial

  • 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.
  • Technique with a blind-protected catheter

Treatment groups

1,500 Participants
are divided into 1 treatment group

Sponsors and collaborators

Biobizkaia Health Research Institute

Lead sponsor

Carlos III Health Institute

Collaborator

Instituto de Investigacion Sanitaria La Fe

Collaborator

European Union

Collaborator

Hospital Universitario 12 de Octubre

Collaborator

Hospital HM Montepríncipe

Collaborator

Hospital General Universitario Gregorio Marañon

Collaborator

Hospital Universitario La Paz

Collaborator

Clinica Universidad de Navarra, Universidad de Navarra

Collaborator

Hospital General Universitario de Castellón

Collaborator

Hospital Clínico Universitario de Valencia

Collaborator

Hospital Donostia

Collaborator

Hospital de Basurto

Collaborator

Complejo Hospitalario Universitario de Pontevedra

Collaborator

Hospital Universitario de Burgos

Collaborator

Hospital Clinico Universitario de Santiago

Collaborator

Hospital Universitari de la Vall de Hebron

Collaborator

Hospital of Navarra

Collaborator

Hospital San Pedro de Alcantara

Collaborator

Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain

Collaborator

Hospital Universitario Central de Asturias

Collaborator

Hospital Universitario Marqués de Valdecilla

Collaborator

Hospitales Universitarios Virgen del Rocío

Collaborator

Complejo Hospitalario de Jaen

Collaborator

Hospital Universitario Puerta del Mar

Collaborator

Hospital Universitario de Jerez de la Frontera

Collaborator

Hospital Materno-Infantil de Málaga

Collaborator

Hospital General Universitario Santa Lucía

Collaborator

Hospital Universitario Virgen de la Arrixaca

Collaborator

Hospital Universitario La Fe

Collaborator

Salamanca University Hospital

Collaborator

Complexo Hospitalario Universitario de A Coruña

Collaborator

Red Salud Materno Infantil y del Desarrollo

Collaborator

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator

University Hospital Virgen de las Nieves

Collaborator

Germans Trias i Pujol Hospital

Collaborator

Hospital del Rio Hortega

Collaborator

Hospital Arnau de Vilanova

Collaborator