PRactice of VENTilation in Critically Ill PEDiatric Patients

NCT ID: NCT06220825

Last Updated: 2025-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2034-04-01

Brief Summary

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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:

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

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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.

Conditions

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Critical Illness Respiratory Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin CJ Kneyber, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Marcus J Schultz, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Frederique Paulus, RN PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC

Locations

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UMC Groningen

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Relin Van Vliet, MSc

Role: CONTACT

0031627560257

David MP van Meenen, MD PhD

Role: CONTACT

Facility Contacts

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Martin CJ Kneyber

Role: primary

0031503614215

Related Links

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Other Identifiers

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PRoVent-PED

Identifier Type: -

Identifier Source: org_study_id

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