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Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns

Primary Purpose

Ventilator Associated Pneumonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
educational program about VAP
Sponsored by
Damanhour University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventilator Associated Pneumonia focused on measuring newborn

Eligibility Criteria

3 Days - 30 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Nurses

    newborns

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    September 22, 2023
    Last Updated
    October 4, 2023
    Sponsor
    Damanhour University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06066489
    Brief Title
    Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
    Official Title
    Effect of Educational Program for Nurses About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    February 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Damanhour University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ventilator Associated Pneumonia
    Keywords
    newborn

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    A prospective, quasi-experimental, pre- and post-study with a one month baseline period; one month intervention period and three months post-intervention period
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    137 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Nurses
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    newborns
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    educational program about VAP
    Intervention Description
    An educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures.
    Primary Outcome Measure Information:
    Title
    prevalence of VAP among newborns ( the number of newborns diagnosed with VAP during the study period
    Description
    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
    Time Frame
    before intervention as baseline ( Day 1), immediately after the intervention, 3 months later after intervention
    Secondary Outcome Measure Information:
    Title
    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
    Description
    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
    Time Frame
    before intervention as baseline(Day 1), immediately after the intervention, 3 months later after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Days
    Maximum Age & Unit of Time
    30 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Basma Ibrahim Khamis, Doctoral
    Phone
    01221880646
    Email
    basmaaibrahim@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30256161
    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.
    Results Reference
    background
    PubMed Identifier
    35773508
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31332968
    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.
    Results Reference
    background

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