- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06066489
Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
October 4, 2023 updated by: Basma Ibrahim, Damanhour University
Effect of Educational Program for Nurses About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
137
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Basma Ibrahim Khamis, Doctoral
- Phone Number: 01221880646
- Email: basmaaibrahim@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nurses
Nurses will be assessed first about their knowledge about VAP then they will receive an educational program about VAP and will be assessed immediately and 3 months after the program
|
An educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures.
|
|
Experimental: newborns
the prevalence of VAP will be assessed among all ventilated newborns who will meet inclusion criteria in the study before implementing the program, immediately and 3 months after the program using PNU1
|
An educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence of VAP among newborns ( the number of newborns diagnosed with VAP during the study period
Time Frame: before intervention as baseline ( Day 1), immediately after the intervention, 3 months later after intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: before intervention as baseline(Day 1), immediately after the intervention, 3 months later after intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 1, 2023
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
September 22, 2023
First Submitted That Met QC Criteria
September 27, 2023
First Posted (Actual)
October 4, 2023
Study Record Updates
Last Update Posted (Actual)
October 6, 2023
Last Update Submitted That Met QC Criteria
October 4, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAP in newborns
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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