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QUAL-REAPED: Performance for French Pediatric Intensive Care Units

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05491018
Collaborator
Ministry of Health, France (Other)
13,270
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Introduction. The measurement of severity scores in adult and pediatric resuscitation provides a tool for evaluating the clinical performance of resuscitation services. No pediatric studies have investigated the association between current procedure and diagnostic cost indices with pediatric ICU patient severity and mortality.

Objectives. The main objective of this project in real-life situations, in 14 French pediatric intensive care units, is to validate the recently available PIM3 and PRISM IV severity scores, which take into account the clinical dimension of performance in pediatric intensive care.

This project is a French multicenter prospective observational research project involving 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP). All patients under 18 years of age admitted to the 14 pediatric intensive care units affiliated with the GFRUP and voluntarily participating in the project will be included in the study.

Expected outcomes are: Validation of PIM3 and PRISM IV scores in a French population to assess clinical performance. To develop a predictive model of mortality and a predictive model of cost in French pediatric intensive care units.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    13270 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units
    Anticipated Study Start Date :
    Dec 1, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Survival : yes / no [At PICU discharge,through study completion, an average of 2 years]

    Secondary Outcome Measures

    1. cost of PICU stay [At PICU discharge,through study completion, an average of 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • All patients under 18 years of age admitted to the 14 pediatric intensive care units and voluntarily participating in the project will be included in the study.
    Exclusion Criteria:
    • Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Lille
    • Ministry of Health, France

    Investigators

    • Principal Investigator: Stéphane Leteurtre, MD,PhD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT05491018
    Other Study ID Numbers:
    • 2018_98
    • PREPS-18-0433
    First Posted:
    Aug 8, 2022
    Last Update Posted:
    Aug 8, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Pediatric
    intensive care
    Severity of Illness
    economic
    scoring system

    Study Results

    No Results Posted as of Aug 8, 2022