NCT06066489

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

October 6, 2023

Status Verified

October 1, 2023

Enrollment Period

4 months

First QC Date

September 22, 2023

Last Update Submit

October 4, 2023

Conditions

Keywords

newborn

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

    before intervention as baseline(Day 1), immediately after the intervention, 3 months later after intervention

Study Arms (2)

Nurses

EXPERIMENTAL

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

Other: educational program about VAP

newborns

EXPERIMENTAL

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

Other: educational program about VAP

Interventions

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

Nursesnewborns

Eligibility Criteria

Age3 Days - 30 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age ≥34 weeks
  • Intubated newborns and those expected to receive mechanical ventilation for more than 48 hours.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 30256161BACKGROUND
  • 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: 35773508BACKGROUND
  • 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: 31332968BACKGROUND

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Basma Ibrahim Khamis, Doctoral

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Model Details: A prospective, quasi-experimental, pre- and post-study with a one month baseline period; one month intervention period and three months post-intervention period
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 4, 2023

Study Start

October 1, 2023

Primary Completion

February 1, 2024

Study Completion

March 1, 2024

Last Updated

October 6, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share