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

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.

Conditions

• Pneumonia Ventilator Associated
• Pneumonia Neonatal
• Healthcare-associated Infections

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.

Sponsors & Collaborators

• Carlos III Health Institute

  collaborator OTHER_GOV

• Instituto de Investigacion Sanitaria La Fe

  collaborator OTHER

• European Union

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital HM Montepríncipe

  collaborator UNKNOWN

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  collaborator OTHER

• Hospital General Universitario de Castellón

  collaborator OTHER

• Hospital Clínico Universitario de Valencia

  collaborator OTHER

• Hospital Donostia

  collaborator OTHER

• Hospital de Basurto

  collaborator OTHER

• Complejo Hospitalario Universitario de Pontevedra

  collaborator OTHER

• Hospital Universitario de Burgos

  collaborator OTHER

• Hospital Clinico Universitario de Santiago

  collaborator OTHER

• Hospital Universitari de la Vall de Hebron

  collaborator UNKNOWN

• Hospital of Navarra

  collaborator OTHER

• Hospital San Pedro de Alcantara

  collaborator OTHER

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

  collaborator UNKNOWN

• Hospital Universitario Central de Asturias

  collaborator OTHER

• Hospital Universitario Marqués de Valdecilla

  collaborator OTHER

• Hospital Universitario Virgen del Rocio

  collaborator UNKNOWN

• Complejo Hospitalario de Jaen

  collaborator UNKNOWN

• Hospital Universitario Puerta del Mar

  collaborator OTHER

• Hospital Universitario de Jerez de la Frontera

  collaborator UNKNOWN

• Hospital Materno-Infantil de Málaga

  collaborator OTHER

• Hospital General Universitario Santa Lucía

  collaborator OTHER

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Hospital Universitario La Fe

  collaborator OTHER

• Salamanca University Hospital

  collaborator OTHER

• Complexo Hospitalario Universitario de A Coruña

  collaborator OTHER

• Red Salud Materno Infantil y del Desarrollo

  collaborator OTHER

• Hospital de la Santa creu i Sant Pau - Barcelona

  collaborator OTHER

• University Hospital Virgen de las Nieves

  collaborator OTHER

• Germans Trias i Pujol Hospital

  collaborator OTHER

• Hospital del Rio Hortega

  collaborator OTHER

• Hospital Arnau de Vilanova

  collaborator OTHER

• Biocruces Bizkaia Health Research Institute

  lead OTHER_GOV

Principal Investigators

• Maria Cruz Lopez Herrera · Biocruces Bizkaia Health Research Institute

Eligibility

Min Age

0 Days

Max Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-26

Primary Completion

2025-12-31

Completion

2026-06-30

Countries

• Spain

Study Locations