PRactice of VENTilation in Critically Ill PEDiatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Critical Illness, Respiratory Failure. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PRactice of VENTilation in Critically Ill PEDiatric Patients (PRoVENT-PED) - an International Multicenter Observational Study
Overview
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. 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:
1. To describe the worldwide practice of ventilatory support in critically ill pediatric patients; and 2. To identify potentially modifiable ventilation parameters that have independent associations with outcome.
Hypothesis:
1. Practice of ventilatory support in critically ill pediatric patients varies substantially worldwide; and 2. 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.
Primary outcome measures
- Tidal volume [Time frame: First four days of (non-)invasive respiratory support]
- Peak inspiratory pressure [Time frame: First four days of (non-)invasive respiratory support]
- Plateau pressure [Time frame: First four days of (non-)invasive respiratory support]
- Positive end-expiratory pressure [Time frame: First four days of (non-)invasive respiratory support]
- Driving pressure [Time frame: First four days of (non-)invasive respiratory support]
- Mechanical power [Time frame: First four days of (non-)invasive respiratory support]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- Expected use of (non-)invasive respiratory support for at least 12 hrs
Exclusion criteria
- premature infants (i.e., postconceptional age corrected for gestational age < 40 weeks)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- UMC Groningen — Groningen
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 PMID 42081907
Identifiers
NCT: NCT06220825 · PRoVent-PED