Ventilator-Associated Pneumonia (VAP), NeonatalNCT07109791
National Surveillance and Prevention of Neonatal VAP
An observational study of Ventilator-Associated Pneumonia (VAP), Neonatal and Bronchopulmonary Dysplasia (BPD), run by University of Alberta at 1 site in Canada.
Trial summary
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born very early (preterm) or very small who often require respiratory support in hospital's… Read more about this study
- Who is it for?
- Ages Up to 24 weeks
- Conditions the study is for
- Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD), Antibiotic-Resistant Organisms (AROs)
- How many people
- 1,500 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to Sep 2029
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 24 weeks
- All sexes
- No healthy volunteers
- Child
Study population: STUDY POPULATION: The study population will include all VLBW infants admitted to participating tertiary NICUs in Canada from 2025-2028 inclusive, diagnosed with VAP at physicians' discretion during their admission.
Who may be able to join
- All VLBW infants admitted to participating tertiary NICUs in Canada
- All neonatal VAP events diagnosed based on the physicians' discretion
Who cannot join
- Infants with major congenital anomalies
- Infants with moribund status on admission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor contact
Christie (Zixuan) Li, Clinical Research Coordinator, BSc, MSc contact
Canada1 site
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Joseph Ting, Staff Neonatologist and Associate Professor, MD, MPH, +1(780) 248-5408, joseph.ting@ualberta.ca
Alena Tse-Chang, Pediatric Infectious Diseases Physician, MD, awtse@ualberta.ca
About this study
Official title: Developing a National Approach to Surveillance and Prevention for Neonatal Ventilator-Associated Pneumonia
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born very early (preterm) or very small who often require respiratory support in hospital's neonatal intensive care units (NICUs).
The main questions it aims to answer are:
Read more
- How often do very-low-birth-weight (VLBW) infants get ventilator-associated pneumonia (VAP) in hospitals across Canada?
- How often are these VAP infections caused by germs that are resistant to antimicrobials (also known as antimicrobial-resistant organisms or AROs)?
- What types of antimicrobial-resistant germs (AROs) are causing them?
- How are these infections being treated with antibiotics, and can we reduce unnecessary antibiotic use?
- Which diagnostic definition is the best and most accurate for diagnosing VAP in newborns, based on real patient data and expert agreement?
- Can we use this information to create clear, evidence-based guidelines that help hospitals prevent and treat VAP in the same, effective way?
Researchers will compare how different hospitals define, report, and manage VAP to devise a shared, evidence-based approach that will lead to more accurate diagnoses and better treatment and outcomes for neonatal VAP.
Researchers will:
- Use data already collected in hospital records (per existing standard of clinical care).
- Analyse how often VAP occurs, how it is diagnosed, and how it is treated
- Work with experts and hospitals to develop and implement a standard, evidence-based plan for diagnosing, managing and preventing VAP in newborns
The overarching goal is to create a clear, nationwide approach to ensure hospitals across Canada care for preterm babies in a standardized manner, reduce infection rates, avoid unnecessary antibiotic use, and improve outcomes for these vulnerable infants.
Read the detailed description
PURPOSE: The purpose of this study is to develop neonatal-specific diagnostic criteria and management guidelines for VAP in VLBW infants in Canadian NICUs, and to improve clinical outcomes through better surveillance, diagnosis, management and antimicrobial stewardship.
HYPOTHESIS:
- We expect substantial variability in VAP incidence across the participating NICUs.
- We expect notable differences in the proportion of VAP events attributable to AROs and in the duration of antimicrobial treatment administered.
AIMS/OBJECTIVES:
- Aim 1: To characterise neonatal VAP incidence by collecting data on infants diagnosed with VAP using three commonly applied definitions, while also identifying AROs, and evaluating patterns of antimicrobial use for VAP treatment across tertiary NICUs.
- Aim 2: To identify the most appropriate, neonatal-specific VAP diagnostic definition by integrating systematically collected clinical data, statistical analyses, and expert consensus through Delphi methodology.
- Aim 3: To translate these findings into practice by developing evidence-based clinical guidelines and tailored implementation strategies for VAP prevention and management.
STUDY POPULATION AND SAMPLE SIZE: The study population will include all VLBW infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion.
RESEARCH METHODS: This project is a multi-centre prospective cohort study, conducted in collaboration with a network of tertiary NICUs in Canada.
- Conditions
- Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD), Antibiotic-Resistant Organisms (AROs), Health-Care Associated Infection (HAI)
- Keywords
- Preterm, Neonate, Neonatal intensive care unit (NICU), Ventilator-Associated Pneumonia (VAP), Healthcare-associated infections (HAI), Invasive mechanical ventilation (IMV), Bronchopulmonary dysplasia (BPD), Antibiotic-resistant organisms (AROs), Antimicrobial stewardship, Implementation science, Quality improvement (QI), Infection surveillance
- Medical subject headings
- Pneumonia, Ventilator-Associated, Bronchopulmonary Dysplasia, Cross Infection, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| VLBW infants with VAP Diagnosis | The study population will include all VLBW infants (birth weight <1500g) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP Incidence
The number of VAP events per 1000 ventilator-days, per the three distinct definitions (Years 1-4).
Unit of Measure: Number of VAP events
Measured: 2025-2028
Secondary outcomes (3)
Prevalence of VAP Among VLBW Infants
The proportion of VLBW infants with at least 1 episode of VAP Unit of Measure: Percentage of participants (%)
Measured: 2025-2028
Other Adverse Outcomes
VAP Recurrence Rate Description: Proportion of participants who experience a recurrence of ventilator-associated pneumonia (VAP) during the study period Unit of Measure: Percentage of participants (%)
Mortality Rate Description: Number of participants who die during the study period Unit of Measure: Number of participants
Number of Participants Diagnosed with Bronchopulmonary Dysplasia (BPD) Description: Number of participants who develop BPD Unit of Measure: Number of participants
Need for Invasive Mechanical Ventilation (IMV) at 36 Weeks Corrected Gestational Age Description: Number of participant
Measured: 2025-2028
VAP Incidence Attributable to AROs
ARO-related VAP events; and the duration of antimicrobial treatment.
Measured: 2025-2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Oct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-Associated Pneumonia (VAP), NeonatalStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of British Columbia, University of Toronto, McGill University
- Responsible party
- Sponsor
- Investigators
- Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109791
- Sponsor's protocol ID
- Pro00149177
- Other IDs
- 202409-197813
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: due to data privacy and regulations
Publications
Li CZ, Tse-Chang A, Yoon EW, Paquette V, Roberts A, Afifi J, Yang CL, Khurshid F, Augustine S, Choudhury J, Elsharkawy A, Hamilton C, Hicks M, Joynt C, Wang D, Lee KS, Louis D, Robinson JL, Mohamed A, Mitra S, Shah VS, Srigley JA, Stavel M, Sherlock R, Wong J, Kuan MT, Madise-Wobo AD, Lemyre B, Joly C, Kharrat A, Gupta-Bhatnagar S, Zarembo M, Bacchini F, Beltempo M, Shah PS, Ting JY. Protocol for developing a national approach to surveillance and prevention for neonatal ventilator-associated pneumonia. BMJ Paediatr Open. 2026 Jan 12;10(1):e004234. doi: 10.1136/bmjpo-2025-004234.
PubMed 41526087
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a National Approach to Surveillance and Prevention for Neonatal Ventilator-Associated Pneumonia
- ClinicalTrials.gov ID
- NCT07109791
- Acronym / sponsor ID
- Pro00149177
- Conditions
- Ventilator-Associated Pneumonia (VAP), Neonatal, Bronchopulmonary Dysplasia (BPD), Antibiotic-Resistant Organisms (AROs), Health-Care Associated Infection (HAI)
- Keywords
- Preterm, Neonate, Neonatal intensive care unit (NICU), Ventilator-Associated Pneumonia (VAP), Healthcare-associated infections (HAI), Invasive mechanical ventilation (IMV), Bronchopulmonary dysplasia (BPD), Antibiotic-resistant organisms (AROs)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Calgary, University of British Columbia, University of Toronto, McGill University
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 7 Aug 2025 (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.
The goal of this observational study is to improve how hospital-acquired lung infections (called ventilator-associated pneumonia, or VAP) are diagnosed, treated and prevented in very low birth weight (VLBW) infants, babies born very early (preterm) or very small who often require respiratory support in hospital's neonatal intensive care units (NICUs).
The main questions it aims to answer are:
- How often do very-low-birth-weight (VLBW) infants get ventilator-associated pneumonia (VAP) in hospitals across Canada?
- How often are these VAP infections caused by germs that are resistant to antimicrobials (also known as antimicrobial-resistant organisms or AROs)?
- What types of antimicrobial-resistant germs (AROs) are causing them?
- How are these infections being treated with antibiotics, and can we reduce unnecessary antibiotic use?
- Which diagnostic definition is the best and most accurate for diagnosing VAP in newborns, based on real patient data and expert agreement?
- Can we use this information to create clear, evidence-based guidelines that help hospitals prevent and treat VAP in the same, effective way?
Researchers will compare how different hospitals define, report, and manage VAP to devise a shared, evidence-based approach that will lead to more accurate diagnoses and better treatment and outcomes for neonatal VAP.
Researchers will:
- Use data already collected in hospital records (per existing standard of clinical care).
- Analyse how often VAP occurs, how it is diagnosed, and how it is treated
- Work with experts and hospitals to develop and implement a standard, evidence-based plan for diagnosing, managing and preventing VAP in newborns
The overarching goal is to create a clear, nationwide approach to ensure hospitals across Canada care for preterm babies in a standardized manner, reduce infection rates, avoid unnecessary antibiotic use, and improve outcomes for these vulnerable infants.
Detailed description
PURPOSE: The purpose of this study is to develop neonatal-specific diagnostic criteria and management guidelines for VAP in VLBW infants in Canadian NICUs, and to improve clinical outcomes through better surveillance, diagnosis, management and antimicrobial stewardship.
HYPOTHESIS:
- We expect substantial variability in VAP incidence across the participating NICUs.
- We expect notable differences in the proportion of VAP events attributable to AROs and in the duration of antimicrobial treatment administered.
AIMS/OBJECTIVES:
- Aim 1: To characterise neonatal VAP incidence by collecting data on infants diagnosed with VAP using three commonly applied definitions, while also identifying AROs, and evaluating patterns of antimicrobial use for VAP treatment across tertiary NICUs.
- Aim 2: To identify the most appropriate, neonatal-specific VAP diagnostic definition by integrating systematically collected clinical data, statistical analyses, and expert consensus through Delphi methodology.
- Aim 3: To translate these findings into practice by developing evidence-based clinical guidelines and tailored implementation strategies for VAP prevention and management.
STUDY POPULATION AND SAMPLE SIZE: The study population will include all VLBW infants (i.e., the group of infants neonates with the highest risk of infections within NICUs) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion.
RESEARCH METHODS: This project is a multi-centre prospective cohort study, conducted in collaboration with a network of tertiary NICUs in Canada.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VLBW infants with VAP Diagnosis | – | –The study population will include all VLBW infants (birth weight <1500g) admitted to participating tertiary NICUs in Canada with diagnoses of VAP at physicians' discretion. |
Who may qualify
- Ages
- Up to 24 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- STUDY POPULATION: The study population will include all VLBW infants admitted to participating tertiary NICUs in Canada from 2025-2028 inclusive, diagnosed with VAP at physicians' discretion during their admission.
Key inclusion criteria (2 listed)
- All VLBW infants admitted to participating tertiary NICUs in Canada
- All neonatal VAP events diagnosed based on the physicians' discretion
Key exclusion criteria (2 listed)
- Infants with major congenital anomalies
- Infants with moribund status on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAP Incidence
Time frame: 2025-2028
The number of VAP events per 1000 ventilator-days, per the three distinct definitions (Years 1-4). Unit of Measure: Number of VAP events
3 secondary outcomes
Prevalence of VAP Among VLBW Infants
Time frame: 2025-2028
Other Adverse Outcomes
Time frame: 2025-2028
VAP Incidence Attributable to AROs
Time frame: 2025-2028
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 41526087Li CZ, Tse-Chang A, Yoon EW, Paquette V, Roberts A, Afifi J, Yang CL, Khurshid F, Augustine S, Choudhury J, Elsharkawy A, Hamilton C, Hicks M, Joynt C, Wang D, Lee KS, Louis D, Robinson JL, Mohamed A, Mitra S, Shah VS, Srigley JA, Stavel M, Sherlock R, Wong J, Kuan MT, Madise-Wobo AD, Lemyre B, Joly C, Kharrat A, Gupta-Bhatnagar S, Zarembo M, Bacchini F, Beltempo M, Shah PS, Ting JY. Protocol for developing a national approach to surveillance and prevention for neonatal ventilator-associated pneumonia. BMJ Paediatr Open. 2026 Jan 12;10(1):e004234. doi: 10.1136/bmjpo-2025-004234.
- Individual participant dataSharing planned: No. due to data privacy and regulations
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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.
Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor contact
Christie (Zixuan) Li, Clinical Research Coordinator, BSc, MSc contact
Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-Associated Pneumonia (VAP), Neonatal and Bronchopulmonary Dysplasia (BPD), run by University of Alberta at 1 site in Canada.
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 2 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: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Joseph Ting, Staff Neonatologist and Clinical Research Professor (+1(780) 248-5408, joseph.ting@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP Incidence (time frame: 2025-2028). 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 NCT07109791, which also lists 1 linked publication.
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 25 Jun 2026.