Actively Recruiting

Age: 0Days - 6Months
All Genders
NCT07240038

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

Led by Biobizkaia Health Research Institute · Updated on 2025-11-20

1500

Participants Needed

39

Research Sites

113 weeks

Total Duration

On this page

Sponsors

B

Biobizkaia Health Research Institute

Lead Sponsor

C

Carlos III Health Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0Days - 6Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 39 locations

1

Hospital Universitario de A Coruña

A Coruña, A Coruña, Spain, 15006

Actively Recruiting

2

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, Spain, 15706

Not Yet Recruiting

3

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, Spain, 02006

Actively Recruiting

4

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain, 08916

Actively Recruiting

5

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain, 08025

Actively Recruiting

6

Hospital Universitario Vall d'Hebrón

Barcelona, Barcelona, Spain, 08035

Actively Recruiting

7

Hospital Universitario de Cruces

Barakaldo, Bizkaia, Spain, 48903

Actively Recruiting

8

Hospital Universitario de Basurto

Bilbao, Bizkaia, Spain, 48013

Actively Recruiting

9

Hospital Universitario de Burgos (HUBU)

Burgos, Burgos, Spain, 09006

Actively Recruiting

10

Hospital San Pedro de Alcántara

Cáceres, Caceres, Spain, 10003

Actively Recruiting

11

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, Spain, 11009

Actively Recruiting

12

Hospital Universitario De Jerez

Jerez de la Frontera, Cadiz, Spain, 11407

Actively Recruiting

13

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain, 39008

Actively Recruiting

14

Hospital Universitario de Donostia

Donostia / San Sebastian, Gipuzkoa, Spain, 20014

Actively Recruiting

15

Hospital Universitario Virgen de las Nieves

Granada, Granada, Spain, 18014

Actively Recruiting

16

Complejo Hospitalario de Jaén

Jaén, Jaen, Spain, 23007

Actively Recruiting

17

Hospital Materno Infantil de Gran Canaria

Las Palmas de Gran Canaria, Las Palmas, Spain, 35016

Actively Recruiting

18

Hospital Universitario de León

León, Leon, Spain, 24008

Actively Recruiting

19

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, Spain, 25198

Actively Recruiting

20

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, Spain, 28660

Actively Recruiting

21

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007

Actively Recruiting

22

Clínica Universidad de Navarra

Madrid, Madrid, Spain, 28027

Not Yet Recruiting

23

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

24

Hospital Universitario La Paz

Madrid, Madrid, Spain, 28046

Actively Recruiting

25

Hospital Regional Universitario de Málaga

Málaga, Malaga, Spain, 29010

Actively Recruiting

26

Hospital General Universitario Santa Lucía

Cartagena, Murcia, Spain, 30202

Not Yet Recruiting

27

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, Spain, 30120

Not Yet Recruiting

28

Clínica Universidad de Navarra - Hospital

Pamplona, Navarre, Spain, 31008

Not Yet Recruiting

29

Hospital Universitario de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

30

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Pontevedra, Spain, 36161

Actively Recruiting

31

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain, 33011

Actively Recruiting

32

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, Spain, 37007

Actively Recruiting

33

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain, 41013

Actively Recruiting

34

Hospital Universitario Nuestra Señora de Valme

Seville, Sevilla, Spain, 41014

Actively Recruiting

35

Hospital General Universitario de Castellón

Castellon, Valencia, Spain, 12004

Actively Recruiting

36

Hospital Clinico Universitario de Valencia

Valencia, Valencia, Spain, 46010

Actively Recruiting

37

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

38

Hospital Universitario Río Hortega

Valladolid, Valladolid, Spain, 47012

Actively Recruiting

39

Hospital Universitario Materno Infantil Miguel Servet

Zaragoza, Zaragoza, Spain, 50009

Actively Recruiting

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Research Team

P

Patricia Sanchez Hernandez

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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