Critical IllnessPRoVent-PEDNCT06220825
PRactice of VENTilation in Critically Ill PEDiatric Patients
An observational study of Critical Illness and Respiratory Failure, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The goal of this worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are: 1. What is the global current practice of ventilatory support in critically ill pediatric patients? 2. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Critical Illness, Respiratory Failure
- How many people
- 2,500 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2024to 1 Apr 2034
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Critically ill pediatric patients
Who may be able to join
- Expected use of (non-)invasive respiratory support for at least 12 hrs
Who cannot join
- premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David MP van Meenen, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
UMC Groningen
Groningen
Martin CJ Kneyber, 0031503614215
About this study
Official title: PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study
The goal of this worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are:
- What is the global current practice of ventilatory support in critically ill pediatric patients?
- Which potentially modifiable factors related to ventilation are associated with outcome? Participating pediatric intensive care units will gather detailed information about ventilation practice and outcome, such as duration of ventilatory support, length of ICU stay and ICU mortality.
Read the detailed description
Rationale:
Studies on ventilatory support in critically ill pediatric patients remain scarce and much of the current clinical practice is based upon experience and data originating from critically ill adult patients.
Objectives:
- To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and
- To identify potentially modifiable ventilation parameters that have independent associations with outcome.
Hypothesis:
- Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and
- Potentially modifiable factors related to ventilation have independent associations with outcome in critically ill pediatric patients.
Study design:
International, multicenter, observational cohort study in critically ill pediatric patients. Each year, data will be collected in two predefined 4-week periods, one in the winter season and one in the summer season. A third 4-week period will be in case of epi- or pandemics. The study is designed to run for 10 years; within these 10 years, there will be subprojects during pre-defined periods. Centers have the option to opt out during certain time periods to make the study manageable for every participating country/center.
Study population:
Critically ill pediatric patients (aged 0-18) admitted to the pediatric intensive care unit (PICU) and necessitating ventilatory support > 12 hours. Premature infants will be excluded. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
- Conditions
- Critical Illness, Respiratory Failure
- Keywords
- Ventilation practice, Critically ill children, PARDS, Mechanical ventilation
- Medical subject headings
- Critical Illness, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume
Tidal volume
Measured: First four days of (non-)invasive respiratory support
Peak inspiratory pressure
Peak inspiratory pressure
Measured: First four days of (non-)invasive respiratory support
Plateau pressure
Pateau pressure
Measured: First four days of (non-)invasive respiratory support
Positive end-expiratory pressure
Positive end-expiratory pressure
Measured: First four days of (non-)invasive respiratory support
Driving pressure
Driving pressure
Measured: First four days of (non-)invasive respiratory support
Mechanical power
Mechanical power
Measured: First four days of (non-)invasive respiratory support
Secondary outcomes (5)
PARDS prevalence
Prevalence of PARDS per PALICC-2 definition
Measured: First four days of (non-)invasive respiratory support
Duration of respiratory support (in days)
Duration of respiratory support (in days)
Measured: Up to 28 days following initiation of (non-)invasive respiratory support
Ventilator-free days at day 28
Ventilator-free days at day 28
Measured: Up to 28 days following initiation of (non-)invasive respiratory support
Length of ICU stay (in days)
Length of ICU stay (in days)
Measured: PICU admission
ICU mortality
ICU mortality
Measured: Up to 28 days following initiation of (non-)invasive respiratory support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2034 (estimated)
- Study completion1 Apr 2034 (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 Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin CJ Kneyber, MD PhD, Principal investigator, University Medical Center GroningenMarcus J Schultz, MD PhD, Principal investigator, Amsterdam UMCFrederique Paulus, RN PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220825
- Sponsor's protocol ID
- PRoVent-PED
- Acronym
- PRoVent-PED
- Status last verified
- Feb 2025
- First submitted
- 8 Jan 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
van Vliet R, Melger JWJ, Bem RA, Blokpoel RGT, Schultz MJ, Paulus F, Kneyber MCJ, van Meenen DMP; PRoVENT-PED steering committee and investigators. Epidemiology, ventilation management, and clinical outcomes in children (PRoVENT-PED): first results from the 10-year, investigator-initiated, international, multicentre, prospective cohort study. Lancet Respir Med. 2026 Jul;14(7):577-588. doi: 10.1016/S2213-2600(26)00044-5. Epub 2026 May 1.
PubMed 42081907
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06220825
- Acronym / sponsor ID
- PRoVent-PED / PRoVent-PED
- Conditions
- Critical Illness, Respiratory Failure
- Keywords
- Ventilation practice, Critically ill children, PARDS, Mechanical ventilation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2034 (estimated)
- Study completion
- 1 Apr 2034 (estimated)
- First posted
- 24 Jan 2024 (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 worldwide observational study is to investigate ventilation practice in critically ill pediatric patients. The main questions it aims to answer are:
- What is the global current practice of ventilatory support in critically ill pediatric patients?
- Which potentially modifiable factors related to ventilation are associated with outcome? Participating pediatric intensive care units will gather detailed information about ventilation practice and outcome, such as duration of ventilatory support, length of ICU stay and ICU mortality.
Detailed description
Rationale:
Studies on ventilatory support in critically ill pediatric patients remain scarce and much of the current clinical practice is based upon experience and data originating from critically ill adult patients.
Objectives:
- To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and
- To identify potentially modifiable ventilation parameters that have independent associations with outcome.
Hypothesis:
- Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and
- Potentially modifiable factors related to ventilation have independent associations with outcome in critically ill pediatric patients.
Study design:
International, multicenter, observational cohort study in critically ill pediatric patients. Each year, data will be collected in two predefined 4-week periods, one in the winter season and one in the summer season. A third 4-week period will be in case of epi- or pandemics. The study is designed to run for 10 years; within these 10 years, there will be subprojects during pre-defined periods. Centers have the option to opt out during certain time periods to make the study manageable for every participating country/center.
Study population:
Critically ill pediatric patients (aged 0-18) admitted to the pediatric intensive care unit (PICU) and necessitating ventilatory support > 12 hours. Premature infants will be excluded. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts or electronic medical records systems is of no risk to the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Critically ill pediatric patients
Key inclusion criteria (1 listed)
- Expected use of (non-)invasive respiratory support for at least 12 hrs
Key exclusion criteria (1 listed)
- premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)
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
Tidal volume
Time frame: First four days of (non-)invasive respiratory support
Tidal volume
Peak inspiratory pressure
Time frame: First four days of (non-)invasive respiratory support
Peak inspiratory pressure
Plateau pressure
Time frame: First four days of (non-)invasive respiratory support
Pateau pressure
Positive end-expiratory pressure
Time frame: First four days of (non-)invasive respiratory support
Positive end-expiratory pressure
Driving pressure
Time frame: First four days of (non-)invasive respiratory support
Driving pressure
Mechanical power
Time frame: First four days of (non-)invasive respiratory support
Mechanical power
5 secondary outcomes
PARDS prevalence
Time frame: First four days of (non-)invasive respiratory support
Duration of respiratory support (in days)
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
Ventilator-free days at day 28
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
Length of ICU stay (in days)
Time frame: PICU admission
ICU mortality
Time frame: Up to 28 days following initiation of (non-)invasive respiratory support
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 7 Feb 2025.
- Derived from this study: PubMed 42081907van Vliet R, Melger JWJ, Bem RA, Blokpoel RGT, Schultz MJ, Paulus F, Kneyber MCJ, van Meenen DMP; PRoVENT-PED steering committee and investigators. Epidemiology, ventilation management, and clinical outcomes in children (PRoVENT-PED): first results from the 10-year, investigator-initiated, international, multicentre, prospective cohort study. Lancet Respir Med. 2026 Jul;14(7):577-588. doi: 10.1016/S2213-2600(26)00044-5. Epub 2026 May 1.
- PRoVent-PED study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
David MP van Meenen, MD PhD contact
Martin CJ Kneyber, MD PhD principal investigator
University Medical Center Groningen
Marcus J Schultz, MD PhD principal investigator
Amsterdam UMC
Frederique Paulus, RN PhD principal investigator
Amsterdam UMC
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 Critical Illness and Respiratory Failure, run by University Medical Center Groningen at 1 site in Netherlands.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 Netherlands. 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 Relin Van Vliet, MSc (0031627560257, r.vanvliet@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume (time frame: First four days of (non-)invasive respiratory support). The study lists 6 primary outcomes in all. 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 NCT06220825, 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 7 Feb 2025.