Severity of Illness IndexQUAL-REAPEDNCT05491018
Performance for French Pediatric Intensive Care Units
An observational study of Severity of Illness Index, run by University Hospital, Lille.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Severity of Illness Index
- How many people
- 13,270 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Oct 2027
- 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: 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP)
Who may be able to join
- 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.
Who cannot join
- Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units
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.
Read more
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.
- Conditions
- Severity of Illness Index
- Keywords
- Pediatric, intensive care, Severity of Illness, economic, scoring system
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival : yes / no
Measured: At PICU discharge,through study completion, an average of 2 years
Secondary outcomes (1)
cost of PICU stay
Measured: At PICU discharge,through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study startJan 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severity of Illness IndexStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- 13,270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Stéphane Leteurtre, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491018
- Sponsor's protocol ID
- 2018_98
- Other IDs
- PREPS-18-0433
- Acronym
- QUAL-REAPED
- Status last verified
- May 2026
- First submitted
- 4 Aug 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units
- ClinicalTrials.gov ID
- NCT05491018
- Acronym / sponsor ID
- QUAL-REAPED / 2018_98
- Conditions
- Severity of Illness Index
- Keywords
- Pediatric, intensive care, Severity of Illness, economic, scoring system
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 13,270 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 8 Aug 2022 (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.
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.
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
- 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.
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
Survival : yes / no
Time frame: At PICU discharge,through study completion, an average of 2 years
1 secondary outcome
cost of PICU stay
Time frame: At PICU discharge,through study completion, an average of 2 years
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 22 May 2026.
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.
Stéphane Leteurtre, MD,PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
An observational study of Severity of Illness Index, run by University Hospital, Lille.
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: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Stéphane Leteurtre, MD,PhD (03 20 44 68 84 ext. +33, stephane.leteurtre@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival : yes / no (time frame: At PICU discharge,through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026; AzTrials last refreshed its copy on 3 Nov 2026.