Ventilator Associated PneumoniaNCT06066489
Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
A study testing educational program about VAP in people with Ventilator Associated Pneumonia, run by Damanhour University.
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. Read more about this study
- Who is it for?
- Ages 3 to 30 days
- Conditions the study is for
- Ventilator Associated Pneumonia
- What is being tested?
- educational program about VAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age ≥34 weeks
- Intubated newborns and those expected to receive mechanical ventilation for more than 48 hours.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- educational program about VAP
- Keywords
- newborn
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational program about VAPOther
An educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: educational program about VAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: before intervention as baseline(Day 1), immediately after the intervention, 3 months later after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ventilator Associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Ibrahim, Damanhour University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066489
- Sponsor's protocol ID
- VAP in newborns
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30256161Alriyami 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.
PubMed 35773508Niedzwiecka 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.
PubMed 31332968
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Educational Program for Nurses About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns
- ClinicalTrials.gov ID
- NCT06066489
- Acronym / sponsor ID
- VAP in newborns
- Conditions
- Ventilator Associated Pneumonia
- Keywords
- newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Nurses | Experimental | Other: educational program about VAPNurses 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 |
| newborns | Experimental | Other: educational program about VAPthe 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 |
Who may qualify
- Ages
- 3 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age ≥34 weeks
- Intubated newborns and those expected to receive mechanical ventilation for more than 48 hours.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational program about VAPAn educational program about VAP that includes VAP bundle from CDC as core measures , equipment related measures and general measures. | Other | Nurses, newborns |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Background: PubMed 30256161Iosifidis 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.
- Background: PubMed 35773508Alriyami 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.
- Background: PubMed 31332968Niedzwiecka 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing educational program about VAP in people with Ventilator Associated Pneumonia, run by Damanhour University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basma Ibrahim Khamis, Doctoral (01221880646, basmaaibrahim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06066489, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.