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| Name | Class |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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:
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:
Hypothesis:
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Tidal volume | Tidal volume | First four days of (non-)invasive respiratory support |
| Peak inspiratory pressure | Peak inspiratory pressure | First four days of (non-)invasive respiratory support |
| Plateau pressure | Pateau pressure | First four days of (non-)invasive respiratory support |
| Positive end-expiratory pressure | Positive end-expiratory pressure | First four days of (non-)invasive respiratory support |
| Driving pressure | Driving pressure | First four days of (non-)invasive respiratory support |
| Mechanical power | Mechanical power | First four days of (non-)invasive respiratory support |
| Measure | Description | Time Frame |
|---|---|---|
| PARDS prevalence | Prevalence of PARDS per PALICC-2 definition | First four days of (non-)invasive respiratory support |
| Duration of respiratory support (in days) | Duration of respiratory support (in days) |
| Measure | Description | Time Frame |
|---|---|---|
| Type of ventilatory support | Type of ventilatory support | First four days of (non-)invasive respiratory support |
| Type of ventilator mode | Ventilator mode |
Inclusion Criteria:
Exclusion Criteria:
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Critically ill pediatric patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Relin Van Vliet, MSc | Contact | 0031627560257 | r.vanvliet@amsterdamumc.nl | |
| David MP van Meenen, MD PhD | Contact | d.m.vanmeenen@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Martin CJ Kneyber, MD PhD | University Medical Center Groningen | Principal Investigator |
| Marcus J Schultz, MD PhD | Amsterdam UMC | Principal Investigator |
| Frederique Paulus, RN PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMC Groningen | Recruiting | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42081907 | Derived | 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. |
| Label | URL |
|---|---|
| PRoVent-PED study website | View source |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| Up to 28 days following initiation of (non-)invasive respiratory support |
| Ventilator-free days at day 28 | Ventilator-free days at day 28 | Up to 28 days following initiation of (non-)invasive respiratory support |
| Length of ICU stay (in days) | Length of ICU stay (in days) | PICU admission |
| ICU mortality | ICU mortality | Up to 28 days following initiation of (non-)invasive respiratory support |
| First four days of (non-)invasive respiratory support |
| Use of sedative and/or analgesic drugs (yes/no) | Use of sedative and/or analgesic drugs | First four days of (non-)invasive respiratory support |
| Use of neuromuscular blocking agents (yes/no) | Use of neuromuscular blocking agents | First four days of (non-)invasive respiratory support |
| Use of vasoactive infusions (yes/no) | Use of vasoactive infusions | First four days of (non-)invasive respiratory support |
| Use of prone positioning (yes/no) | Use of prone positioning | First four days of (non-)invasive respiratory support |
| Use of ECMO (yes/no) | Use of ECMO | First four days of (non-)invasive respiratory support |
| Amsterdam UMC |
| Principal Investigator |
| D012140 | Respiratory Tract Diseases |