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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06066489
Other study ID # VAP in newborns
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2023
Est. completion date March 2024

Study information

Verified date October 2023
Source Damanhour University
Contact Basma Ibrahim Khamis, Doctoral
Phone 01221880646
Email basmaaibrahim@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to investigate the effect of educational program for nurses about preventive care bundle for prevention of ventilator associated pneumonia among newborns.


Description:

Neonatal ventilator associated pneumonia (VAP) is a common nosocomial infection and a frequent reason for empirical antibiotic therapy in NICUs. Ventilator associated pneumonia (VAP) is defined as a nosocomial lower airway infection in intubated patients with onset after 48 h or more of invasive mechanical ventilation.Prevention of VAP has been primarily achieved by the "bundle approach"; this involves the simultaneous application of several preventive strategies for all patients.In Egypt and other developing countries, reports on the success of VAP intervention strategies, particularly among neonates, are scarce. So, it is important to conduct educational programs for nurses about VAP to decrease its incidence.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 137
Est. completion date March 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 3 Days to 30 Days
Eligibility Inclusion Criteria: - Gestational age =34 weeks - Intubated newborns and those expected to receive mechanical ventilation for more than 48 hours. Exclusion Criteria: - Newborns with diagnosis of pneumonia at the time of admission. - Newborns developed pneumonia in the first 48 hours of mechanical ventilation. - Newborns subjected to reintubation. - Immunosuppressed newborns.

Study Design


Intervention

Other:
educational program about VAP
An educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Damanhour University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of VAP among newborns ( the number of newborns diagnosed with VAP during the study period prevalence of VAP will be compared before application of educational program for nurses about preventive care bundle for prevention of VAP and after the program ( immediately, 3 months later) by using centers for disease control and prevention PNU-1 before intervention as baseline ( Day 1), immediately after the intervention, 3 months later after intervention
Secondary nurses practices about prevention of ventilator associated pneumonia after implementing the training program will be compared by their practices before the intervention using Observational Checklist nurses practices will be assessed before and after the intervention immediately and 3 months later using Observational Checklist about their practices and then results compared before and after the intervention by mean percent score before intervention as baseline(Day 1), immediately after the intervention, 3 months later after intervention
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