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

NCT07240038 | Recruiting

• 2 other identifiers: INBERNAV-Neo-21/01513PI2024002
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 39

Brief 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

Keywords

neonate; ventilator-associated pneumonia; quasi-experimental; multicenter; prevention; epidemiologic surveillance; clinical diagnosis; microbiological diagnostics; NICU; intervention; good clinical practice; patient safety

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect of a multimodal intervention, based on good clinical practices for the clinical management of neonates on invasive ventilatory support, on the incidence of VAP in neonates admitted to Spanish NICUs.

  From the initiation of IMV until extubation plus an additional 2 days of monitoring in some cases.

Secondary Outcomes (7)

• Systematic literature review to identify the best available scientific evidence for the unification of diagnostic criteria for VAP in neonates, and to propose evidence-based preventive measures.

  An initial literature collection period of 9 months, followed by continuous updates throughout 2 years.

• Secure and user-friendly web-based registry system (Neo-NAV) for participating centers to record episodes of invasive mechanical ventilation (and VAP, if present) in neonates.

  28 months.

• Certified and interactive online course on the Moodle platform for training healthcare professionals in standardized diagnosis and prevention of neonatal VAP.

  15 months.

• To provide information and training on the use of telescoping catheter techniques for diagnostic purposes.

  15 months.

• . Development of a dedicated section within the Neo-NAV platform for recording preventive measures implemented against VAP in neonates at each participating hospital.

  Every 4 months during a 20-month period.

Study Arms (1)

Patients admitted to participating NICUs who require mechanical ventilation

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.; Diagnostic Test: Technique with a blind-protected catheter

Interventions

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. BEHAVIORAL

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. .

Patients admitted to participating NICUs who require mechanical ventilation

Technique with a blind-protected catheter DIAGNOSTIC_TEST

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.

Patients admitted to participating NICUs who require mechanical ventilation

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients from Spanish level III and II NICUs with an average annual incidence of at least 5 neonatal patients on invasive mechanical ventilation (IMV) for ≥ 48 hours, who agree to participate and form teams to implement the best practice bundles developed to improve the care of patients on IMV. The included patients will be admitted neonates requiring IMV, regardless of birth weight or gestational age.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biobizkaia Health Research Institute: lead
• 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
• Hospital Universitario Virgen del Rocio: 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

Study Sites (39)

Hospital Universitario de A Coruña

A Coruña, A Coruña, 15006, Spain

RECRUITING

Hospital Clínico Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

NOT YET RECRUITING

Complejo Hospitalario Universitario de Albacete

Albacete, Albacete, 02006, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

RECRUITING

Hospital Universitario Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de Cruces

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

Hospital Universitario de Basurto

Bilbao, Bizkaia, 48013, Spain

RECRUITING

Hospital Universitario de Burgos (HUBU)

Burgos, Burgos, 09006, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Caceres, 10003, Spain

RECRUITING

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, 11009, Spain

RECRUITING

Hospital Universitario De Jerez

Jerez de la Frontera, Cadiz, 11407, Spain

RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

RECRUITING

Hospital Universitario de Donostia

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

RECRUITING

Hospital Universitario Virgen de las Nieves

Granada, Granada, 18014, Spain

RECRUITING

Complejo Hospitalario de Jaén

Jaén, Jaen, 23007, Spain

RECRUITING

Hospital Materno Infantil de Gran Canaria

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

RECRUITING

Hospital Universitario de León

León, Leon, 24008, Spain

RECRUITING

Hospital Universitario Arnau de Vilanova

Lleida, Lleida, 25198, Spain

RECRUITING

Hospital Universitario HM Monteprincipe

Boadilla del Monte, Madrid, 28660, Spain

RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, 28007, Spain

RECRUITING

Clínica Universidad de Navarra

Madrid, Madrid, 28027, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, Malaga, 29010, Spain

RECRUITING

Hospital General Universitario Santa Lucía

Cartagena, Murcia, 30202, Spain

NOT YET RECRUITING

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Murcia, 30120, Spain

NOT YET RECRUITING

Clínica Universidad de Navarra - Hospital

Pamplona, Navarre, 31008, Spain

NOT YET RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Complejo Hospitalario Universitario de Pontevedra

Pontevedra, Pontevedra, 36161, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

RECRUITING

Hospital Clínico Universitario de Salamanca

Salamanca, Salamanca, 37007, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

RECRUITING

Hospital Universitario Nuestra Señora de Valme

Seville, Sevilla, 41014, Spain

RECRUITING

Hospital General Universitario de Castellón

Castellon, Valencia, 12004, Spain

RECRUITING

Hospital Clinico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Hospital Universitario Río Hortega

Valladolid, Valladolid, 47012, Spain

RECRUITING

Hospital Universitario Materno Infantil Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

RECRUITING

Related Publications (57)

• Williams L. Ventilator-Associated Pneumonia Precautions for Children: What Is the Evidence? AACN Adv Crit Care. 2019 Spring;30(1):68-71. doi: 10.4037/aacnacc2019812. No abstract available.

  PMID: 30842077 BACKGROUND

• Williams EE, Arattu Thodika FMS, Chappelow I, Chapman-Hatchett N, Dassios T, Greenough A. Diaphragmatic electromyography during a spontaneous breathing trial to predict extubation failure in preterm infants. Pediatr Res. 2022 Oct;92(4):1064-1069. doi: 10.1038/s41390-022-02085-w. Epub 2022 May 6.

  PMID: 35523885 BACKGROUND

• WHO Guidelines on Hand Hygiene in Health Care: First Global Patient Safety Challenge Clean Care Is Safer Care. Geneva: World Health Organization; 2009. Available from http://www.ncbi.nlm.nih.gov/books/NBK144013/

  PMID: 23805438 BACKGROUND

• Wang L, Du KN, Zhao YL, Yu YJ, Sun L, Jiang HB. Risk Factors of Nosocomial Infection for Infants in Neonatal Intensive Care Units: A Systematic Review and Meta-Analysis. Med Sci Monit. 2019 Nov 1;25:8213-8220. doi: 10.12659/MSM.917185.

  PMID: 31675354 BACKGROUND

• Wang HC, Liao CC, Chu SM, Lai MY, Huang HR, Chiang MC, Fu RH, Hsu JF, Tsai MH. Impacts of Multidrug-Resistant Pathogens and Inappropriate Initial Antibiotic Therapy on the Outcomes of Neonates with Ventilator-Associated Pneumonia. Antibiotics (Basel). 2020 Oct 30;9(11):760. doi: 10.3390/antibiotics9110760.

  PMID: 33143219 BACKGROUND

• van Leuteren RW, de Waal CG, de Jongh FH, Bem RA, van Kaam AH, Hutten G. Diaphragm Activity Pre and Post Extubation in Ventilated Critically Ill Infants and Children Measured With Transcutaneous Electromyography. Pediatr Crit Care Med. 2021 Nov 1;22(11):950-959. doi: 10.1097/PCC.0000000000002828.

  PMID: 34534162 BACKGROUND

• Tusor N, De Cunto A, Basma Y, Klein JL, Meau-Petit V. Ventilator-associated pneumonia in neonates: the role of point of care lung ultrasound. Eur J Pediatr. 2021 Jan;180(1):137-146. doi: 10.1007/s00431-020-03710-8. Epub 2020 Jun 26.

  PMID: 32592026 BACKGROUND

• Thibeau S, Boudreaux C. Exploring the use of mothers' own milk as oral care for mechanically ventilated very low-birth-weight preterm infants. Adv Neonatal Care. 2013 Jun;13(3):190-7. doi: 10.1097/ANC.0b013e318285f8e2.

  PMID: 23722491 BACKGROUND

• Thatrimontrichai A, Rujeerapaiboon N, Janjindamai W, Dissaneevate S, Maneenil G, Kritsaneepaiboon S, Tanaanantarak P. Outcomes and risk factors of ventilator-associated pneumonia in neonates. World J Pediatr. 2017 Aug;13(4):328-334. doi: 10.1007/s12519-017-0010-0. Epub 2017 Jan 25.

  PMID: 28120236 BACKGROUND

• Tan B, Zhang F, Zhang X, Huang YL, Gao YS, Liu X, Li YL, Qiu JF. Risk factors for ventilator-associated pneumonia in the neonatal intensive care unit: a meta-analysis of observational studies. Eur J Pediatr. 2014 Apr;173(4):427-34. doi: 10.1007/s00431-014-2278-6. Epub 2014 Feb 13.

  PMID: 24522325 BACKGROUND

• Ryan RM, Wilding GE, Wynn RJ, Welliver RC, Holm BA, Leach CL. Effect of enhanced ultraviolet germicidal irradiation in the heating ventilation and air conditioning system on ventilator-associated pneumonia in a neonatal intensive care unit. J Perinatol. 2011 Sep;31(9):607-14. doi: 10.1038/jp.2011.16. Epub 2011 Mar 24.

  PMID: 21436785 BACKGROUND

• Rosenthal VD, Alvarez-Moreno C, Villamil-Gomez W, Singh S, Ramachandran B, Navoa-Ng JA, Duenas L, Yalcin AN, Ersoz G, Menco A, Arrieta P, Bran-de Casares AC, de Jesus Machuca L, Radhakrishnan K, Villanueva VD, Tolentino MC, Turhan O, Keskin S, Gumus E, Dursun O, Kaya A, Kuyucu N. Effectiveness of a multidimensional approach to reduce ventilator-associated pneumonia in pediatric intensive care units of 5 developing countries: International Nosocomial Infection Control Consortium findings. Am J Infect Control. 2012 Aug;40(6):497-501. doi: 10.1016/j.ajic.2011.08.005. Epub 2011 Nov 3.

  PMID: 22054689 BACKGROUND

• Rosenthal VD, Al-Abdely HM, El-Kholy AA, AlKhawaja SAA, Leblebicioglu H, Mehta Y, Rai V, Hung NV, Kanj SS, Salama MF, Salgado-Yepez E, Elahi N, Morfin Otero R, Apisarnthanarak A, De Carvalho BM, Ider BE, Fisher D, Buenaflor MCSG, Petrov MM, Quesada-Mora AM, Zand F, Gurskis V, Anguseva T, Ikram A, Aguilar de Moros D, Duszynska W, Mejia N, Horhat FG, Belskiy V, Mioljevic V, Di Silvestre G, Furova K, Ramos-Ortiz GY, Gamar Elanbya MO, Satari HI, Gupta U, Dendane T, Raka L, Guanche-Garcell H, Hu B, Padgett D, Jayatilleke K, Ben Jaballah N, Apostolopoulou E, Prudencio Leon WE, Sepulveda-Chavez A, Telechea HM, Trotter A, Alvarez-Moreno C, Kushner-Davalos L; Remaining authors. International Nosocomial Infection Control Consortium report, data summary of 50 countries for 2010-2015: Device-associated module. Am J Infect Control. 2016 Dec 1;44(12):1495-1504. doi: 10.1016/j.ajic.2016.08.007. Epub 2016 Oct 11.

  PMID: 27742143 BACKGROUND

• Raycheva R, Rangelova V, Kevorkyan A. Cost Analysis for Patients with Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit. Healthcare (Basel). 2022 May 25;10(6):980. doi: 10.3390/healthcare10060980.

  PMID: 35742032 BACKGROUND

• Ramirez-Estrada S, Pena-Lopez Y, Vieceli T, Rello J. Ventilator-associated events: From surveillance to optimizing management. J Intensive Med. 2022 Nov 12;3(3):204-211. doi: 10.1016/j.jointm.2022.09.004. eCollection 2023 Jul 31.

  PMID: 37533808 BACKGROUND

• Rallis D, Ben-David D, Woo K, Robinson J, Beadles D, Spyropoulos F, Christou H, Cataltepe S. Predictors of successful extubation from volume-targeted ventilation in extremely preterm neonates. J Perinatol. 2024 Feb;44(2):250-256. doi: 10.1038/s41372-023-01849-4. Epub 2023 Dec 20.

  PMID: 38123799 BACKGROUND

• Pittet D, Hugonnet S, Harbarth S, Mourouga P, Sauvan V, Touveneau S, Perneger TV. Effectiveness of a hospital-wide programme to improve compliance with hand hygiene. Infection Control Programme. Lancet. 2000 Oct 14;356(9238):1307-12. doi: 10.1016/s0140-6736(00)02814-2.

  PMID: 11073019 BACKGROUND

• Pinilla-Gonzalez A, Solaz-Garcia A, Parra-Llorca A, Lara-Canton I, Gimeno A, Izquierdo I, Vento M, Cernada M. Preventive bundle approach decreases the incidence of ventilator-associated pneumonia in newborn infants. J Perinatol. 2021 Jun;41(6):1467-1473. doi: 10.1038/s41372-021-01086-7. Epub 2021 May 25.

  PMID: 34035449 BACKGROUND

• Pinilla-Gonzalez A, Lara-Canton I, Torrejon-Rodriguez L, Parra-Llorca A, Aguar M, Kuligowski J, Pineiro-Ramos JD, Sanchez-Illana A, Navarro AG, Vento M, Cernada M. Early molecular markers of ventilator-associated pneumonia in bronchoalveolar lavage in preterm infants. Pediatr Res. 2023 May;93(6):1559-1565. doi: 10.1038/s41390-022-02271-w. Epub 2022 Sep 7.

  PMID: 36071239 BACKGROUND

• Parker LA, Weaver M, Murgas Torrazza RJ, Shuster J, Li N, Krueger C, Neu J. Effect of Gastric Residual Evaluation on Enteral Intake in Extremely Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2019 Jun 1;173(6):534-543. doi: 10.1001/jamapediatrics.2019.0800.

  PMID: 31034045 BACKGROUND

• Ohnstad MO, Stensvold HJ, Pripp AH, Tvedt CR, Jelsness-Jorgensen LP, Astrup H, Eriksen BH, Klingenberg C, Mreihil K, Pedersen T, Rettedal S, Selberg TR, Solberg R, Stoen R, Ronnestad AE; Norwegian Neonatal Network. Predictors of extubation success: a population-based study of neonates below a gestational age of 26 weeks. BMJ Paediatr Open. 2022 Aug;6(1):e001542. doi: 10.1136/bmjpo-2022-001542.

  PMID: 36053650 BACKGROUND

• Niedzwiecka T, Patton D, Walsh S, Moore Z, O'Connor T, Nugent L. What are the effects of care bundles on the incidence of ventilator-associated pneumonia in paediatric and neonatal intensive care units? A systematic review. J Spec Pediatr Nurs. 2019 Oct;24(4):e12264. doi: 10.1111/jspn.12264. Epub 2019 Jul 23.

  PMID: 31332968 BACKGROUND

• Mohsen N, Nasef N, Ghanem M, Yeung T, Deekonda V, Ma C, Kajal D, Baczynski M, Jain A, Mohamed A. Accuracy of lung and diaphragm ultrasound in predicting successful extubation in extremely preterm infants: A prospective observational study. Pediatr Pulmonol. 2023 Feb;58(2):530-539. doi: 10.1002/ppul.26223. Epub 2022 Nov 11.

  PMID: 36324211 BACKGROUND

• Manzoni P, De Luca D, Stronati M, Jacqz-Aigrain E, Ruffinazzi G, Luparia M, Tavella E, Boano E, Castagnola E, Mostert M, Farina D. Prevention of nosocomial infections in neonatal intensive care units. Am J Perinatol. 2013 Feb;30(2):81-8. doi: 10.1055/s-0032-1333131. Epub 2013 Jan 4.

  PMID: 23292914 BACKGROUND

• Lin Y, Sun Z, Wang H, Liu M. The Effects of Gastrointestinal Function on the Incidence of Ventilator-associated Pneumonia in Critically Ill Patients. Open Med (Wars). 2018 Dec 6;13:556-561. doi: 10.1515/med-2018-0082. eCollection 2018.

  PMID: 30564634 BACKGROUND

• Lambe KA, Lydon S, Madden C, Vellinga A, Hehir A, Walsh M, O'Connor P. Hand Hygiene Compliance in the ICU: A Systematic Review. Crit Care Med. 2019 Sep;47(9):1251-1257. doi: 10.1097/CCM.0000000000003868.

  PMID: 31219838 BACKGROUND

• Klompas M, Branson R, Cawcutt K, Crist M, Eichenwald EC, Greene LR, Lee G, Maragakis LL, Powell K, Priebe GP, Speck K, Yokoe DS, Berenholtz SM. Strategies to prevent ventilator-associated pneumonia, ventilator-associated events, and nonventilator hospital-acquired pneumonia in acute-care hospitals: 2022 Update. Infect Control Hosp Epidemiol. 2022 Jun;43(6):687-713. doi: 10.1017/ice.2022.88. Epub 2022 May 20.

  PMID: 35589091 BACKGROUND

• Jacobs Pepin B, Lesslie D, Berg W, Spaulding AB, Pokora T. ZAP-VAP: A Quality Improvement Initiative to Decrease Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit, 2012-2016. Adv Neonatal Care. 2019 Aug;19(4):253-261. doi: 10.1097/ANC.0000000000000635.

  PMID: 31246616 BACKGROUND

• Iosifidis E, Pitsava G, Roilides E. Ventilator-associated pneumonia in neonates and children: a systematic analysis of diagnostic methods and prevention. Future Microbiol. 2018 Sep;13:1431-1446. doi: 10.2217/fmb-2018-0108. Epub 2018 Sep 26.

  PMID: 30256161 BACKGROUND

• Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.

  PMID: 32598319 BACKGROUND

• Gurskis V, Asembergiene J, Kevalas R, Miciuleviciene J, Pavilonis A, Valinteliene R, Dagys A. Reduction of nosocomial infections and mortality attributable to nosocomial infections in pediatric intensive care units in Lithuania. Medicina (Kaunas). 2009;45(3):203-13.

  PMID: 19357450 BACKGROUND

• Gupta D, Greenberg RG, Sharma A, Natarajan G, Cotten M, Thomas R, Chawla S. A predictive model for extubation readiness in extremely preterm infants. J Perinatol. 2019 Dec;39(12):1663-1669. doi: 10.1038/s41372-019-0475-x. Epub 2019 Aug 27.

  PMID: 31455825 BACKGROUND

• Gupta A, Kapil A, Kabra SK, Lodha R, Sood S, Dhawan B, Das BK, Sreenivas V. Assessing the impact of an educational intervention on ventilator-associated pneumonia in a pediatric critical care unit. Am J Infect Control. 2014 Feb;42(2):111-5. doi: 10.1016/j.ajic.2013.09.026.

  PMID: 24485367 BACKGROUND

• Gomez-Rios MA, Sastre JA, Lopez T, Gaszynski T. Disinfection of Reusable Laryngoscopes: A Survey about the Clinical Practice in Spain. Healthcare (Basel). 2023 Apr 13;11(8):1117. doi: 10.3390/healthcare11081117.

  PMID: 37107952 BACKGROUND

• Gokce IK, Kutman HGK, Uras N, Canpolat FE, Dursun Y, Oguz SS. Successful Implementation of a Bundle Strategy to Prevent Ventilator-Associated Pneumonia in a Neonatal Intensive Care Unit. J Trop Pediatr. 2018 Jun 1;64(3):183-188. doi: 10.1093/tropej/fmx044.

  PMID: 28575489 BACKGROUND

• Goerens A, Lehnick D, Buttcher M, Daetwyler K, Fontana M, Genet P, Lura M, Morgillo D, Pilgrim S, Schwendener-Scholl K, Regamey N, Neuhaus TJ, Stocker M. Neonatal Ventilator Associated Pneumonia: A Quality Improvement Initiative Focusing on Antimicrobial Stewardship. Front Pediatr. 2018 Sep 24;6:262. doi: 10.3389/fped.2018.00262. eCollection 2018.

  PMID: 30320046 BACKGROUND

• Glowicz JB, Landon E, Sickbert-Bennett EE, Aiello AE, deKay K, Hoffmann KK, Maragakis L, Olmsted RN, Polgreen PM, Trexler PA, VanAmringe MA, Wood AR, Yokoe D, Ellingson KD. SHEA/IDSA/APIC Practice Recommendation: Strategies to prevent healthcare-associated infections through hand hygiene: 2022 Update. Infect Control Hosp Epidemiol. 2023 Mar;44(3):355-376. doi: 10.1017/ice.2022.304. Epub 2023 Feb 8.

  PMID: 36751708 BACKGROUND

• Gauvin F, Dassa C, Chaibou M, Proulx F, Farrell CA, Lacroix J. Ventilator-associated pneumonia in intubated children: comparison of different diagnostic methods. Pediatr Crit Care Med. 2003 Oct;4(4):437-43. doi: 10.1097/01.PCC.0000090290.53959.F4.

  PMID: 14525638 BACKGROUND

• Garland JS. Strategies to prevent ventilator-associated pneumonia in neonates. Clin Perinatol. 2010 Sep;37(3):629-43. doi: 10.1016/j.clp.2010.05.003.

  PMID: 20813275 BACKGROUND

• Gao Y, Yin H, Wang MH, Gao YH. Accuracy of lung and diaphragm ultrasound in predicting infant weaning outcomes: a systematic review and meta-analysis. Front Pediatr. 2023 Sep 6;11:1211306. doi: 10.3389/fped.2023.1211306. eCollection 2023.

  PMID: 37744441 BACKGROUND

• Foglia E, Meier MD, Elward A. Ventilator-associated pneumonia in neonatal and pediatric intensive care unit patients. Clin Microbiol Rev. 2007 Jul;20(3):409-25, table of contents. doi: 10.1128/CMR.00041-06.

  PMID: 17630332 BACKGROUND

• Ezzeldin Z, Mansi Y, Gaber M, Zakaria R, Fawzy R, Mohamed MA. Nebulized hypertonic saline to prevent ventilator associated pneumonia in premature infants, a randomized trial. J Matern Fetal Neonatal Med. 2018 Nov;31(22):2947-2952. doi: 10.1080/14767058.2017.1359826. Epub 2017 Aug 8.

  PMID: 28738709 BACKGROUND

• Esteban E, Ferrer R, Urrea M, Suarez D, Rozas L, Balaguer M, Palomeque A, Jordan I. The impact of a quality improvement intervention to reduce nosocomial infections in a PICU. Pediatr Crit Care Med. 2013 Jun;14(5):525-32. doi: 10.1097/PCC.0b013e31828a87cc.

  PMID: 23867430 BACKGROUND

• El Amrousy D, Elgendy M, Eltomey M, Elmashad AE. Value of lung ultrasonography to predict weaning success in ventilated neonates. Pediatr Pulmonol. 2020 Sep;55(9):2452-2456. doi: 10.1002/ppul.24934. Epub 2020 Jul 8.

  PMID: 32609928 BACKGROUND

• Sonmez Duzkaya D, Yildiz S. Effect of two different feeding methods on preventing ventilator associated pneumonia in the paediatric intensive care unit (PICU): A randomised controlled study. Aust Crit Care. 2016 Aug;29(3):139-45. doi: 10.1016/j.aucc.2015.11.001. Epub 2015 Dec 2.

  PMID: 26652811 BACKGROUND

• Dang J, He L, Li C. Risk factors for neonatal VAP: A retrospective cohort study. Exp Biol Med (Maywood). 2023 Dec;248(23):2473-2480. doi: 10.1177/15353702231220673. Epub 2023 Dec 30.

  PMID: 38159075 BACKGROUND

• Claassen CC, Keenan WJ. Challenging the "Culture" of the Tracheal Aspirate. Neoreviews. 2019 Mar;20(3):e145-e151. doi: 10.1542/neo.20-3-e145.

  PMID: 31261052 BACKGROUND

• Chen YH, Lin HL, Sung YH, Hsu JF, Chu SM. Analysis of predictive parameters for extubation in very low birth weight preterm infants. Pediatr Neonatol. 2023 May;64(3):274-279. doi: 10.1016/j.pedneo.2022.08.007. Epub 2022 Nov 14.

  PMID: 36443202 BACKGROUND

• Cernada M, Brugada M, Golombek S, Vento M. Ventilator-associated pneumonia in neonatal patients: an update. Neonatology. 2014;105(2):98-107. doi: 10.1159/000355539. Epub 2013 Nov 29.

  PMID: 24296586 BACKGROUND

• Cernada M, Aguar M, Brugada M, Gutierrez A, Lopez JL, Castell M, Vento M. Ventilator-associated pneumonia in newborn infants diagnosed with an invasive bronchoalveolar lavage technique: a prospective observational study. Pediatr Crit Care Med. 2013 Jan;14(1):55-61. doi: 10.1097/PCC.0b013e318253ca31.

  PMID: 22791095 BACKGROUND

• Brachio SS, Gu W, Saiman L. Next Steps for Health Care-Associated Infections in the Neonatal Intensive Care Unit. Clin Perinatol. 2023 Jun;50(2):381-397. doi: 10.1016/j.clp.2023.02.001. Epub 2023 Apr 4.

  PMID: 37201987 BACKGROUND

• Azab SF, Sherbiny HS, Saleh SH, Elsaeed WF, Elshafiey MM, Siam AG, Arafa MA, Alghobashy AA, Bendary EA, Basset MA, Ismail SM, Akeel NE, Elsamad NA, Mokhtar WA, Gheith T. Reducing ventilator-associated pneumonia in neonatal intensive care unit using "VAP prevention Bundle": a cohort study. BMC Infect Dis. 2015 Aug 6;15:314. doi: 10.1186/s12879-015-1062-1.

  PMID: 26246314 BACKGROUND

• Arthur N, Kaur I, Carey AJ. Evaluation of the applicability of the current CDC pediatric ventilator-associated events (PedVAE) surveillance definition in the neonatal intensive care unit population. BMC Pediatr. 2022 Apr 7;22(1):185. doi: 10.1186/s12887-022-03236-y.

  PMID: 35392855 BACKGROUND

• Alriyami A, Kiger JR, Hooven TA. Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit. Neoreviews. 2022 Jul 1;23(7):e448-e461. doi: 10.1542/neo.23-7-e448.

  PMID: 35773508 BACKGROUND

• Aggarwal R, Plakkal N, Bhat V. Does oropharyngeal administration of colostrum reduce morbidity and mortality in very preterm infants? A randomised parallel-group controlled trial. J Paediatr Child Health. 2021 Sep;57(9):1467-1472. doi: 10.1111/jpc.15529. Epub 2021 Apr 28.

  PMID: 33908117 BACKGROUND

• Weber CD. Applying Adult Ventilator-associated Pneumonia Bundle Evidence to the Ventilated Neonate. Adv Neonatal Care. 2016 Jun;16(3):178-90. doi: 10.1097/ANC.0000000000000276.

  PMID: 27195470 BACKGROUND

• Abiramalatha T, Ramaswamy VV, Thanigainathan S, Pullattayil AK, Kirubakaran R. Frequency of ventilator circuit changes to prevent ventilator-associated pneumonia in neonates and children-A systematic review and meta-analysis. Pediatr Pulmonol. 2021 Jun;56(6):1357-1365. doi: 10.1002/ppul.25345. Epub 2021 Mar 13.

  PMID: 33713572 BACKGROUND

Related Links

• European Centre for Disease Prevention and Control. Hand hygiene (2015)
• Ministerio de Sanidad. Seguridad del Paciente
• Organización Mundial de la Salud. Report on the burden of endemic health care-associated infection worldwide. Geneva: World Health Organization (2011)
• Osakidetza. Estrategia de Seguridad del Paciente 2030
• Pneumonia (Ventilator-associated \[VAP\] and non-ventilatorassociated Pneumonia \[PNEU\]) Event. Device-associated Module PNEU. CDC (2024)
• Ventilator-Associated Event (VAE). Device-associated Module VAE. CDC (2024)
• World Health Organization, WHO Patient Safety. Hand hygiene technical reference manual: to be used by health-care workers, trainers and observers of hand hygiene practices (2009)

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Cross Infection

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Cruz Lopez Herrera

  Biobizkaia Health Research Institute

  STUDY DIRECTOR

Central Study Contacts

Patricia Sanchez Hernandez

CONTACT

946006136; patricia.sanchezhernandez@bio-bizkaia.eus

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 365 Days
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: November 20, 2025
• Study Start: April 26, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

ES (39)