Critical IllnessNCT02304341
Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study
An observational study of Critical Illness, run by University Hospital, Lille at 7 sites in France.
Trial summary
Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Critical Illness
- How many people
- 3,016 participants
- Where
- 7 sitesFrance
- Study dates
- Sep 2012to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children admitted to the paediatric inpatient unit in 7 regional hospitals French
Who may be able to join
- All children admitted to the paediatric inpatient unit
Who cannot join
- parental refusal
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier Général
Arras
Centre hospitalier général
Boulogne-sur-Mer
Centre Hospitalier Général
Cambrai
Centre Hospitalier Général
Douai
Centre Hospitalier général
Dunkirk
Centre Hospitalier Général
Lens
Centre Hospitalier Général
Roubaix
About this study
Official title: Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study.
Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.
- Conditions
- Critical Illness
- Keywords
- critical illness, disease progression, child, severity of illness index, monitoring
- Medical subject headings
- Critical Illness, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| intermediate units | Children admitted to the paediatric inpatient unit in 7 regional hospitals French |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed inPaediatric Advanced Warning Score (PAWS)
Temperature, Capillary Refill Time (CRT), respiratory rate, heart rate,neurological status, oxygen saturation, respiratory distress measure at admission, each 8 hours and if deteriorations
Measured: at admission and each 8 hours, up to 5 days
Secondary outcomes (2)
Changed in Pediatric Early Warning System score (PEWS)
heart rate, systolic blood pressure, Capillary Refill Time (CRT), respiratory rate, respiratory effort,transcutaneous oxygen saturation and oxygen therapy are measured at admission, each 8 hours and if deteriorations
Measured: at admission and each 8 hours, up to 5 days
Transfer in pediatric intensive care (YES/NO)
this secondary outcome is evaluated when the bedPEWS and PAWS scores are collected : at admission, each 8 hours and if deterioration
Measured: at each 8 hours, up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2014 (estimated)
- Study startSep 2012
- Primary completionJan 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies 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
- 3,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Stephane LETEURTRE, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02304341
- Sponsor's protocol ID
- 2011_20
- Other IDs
- PHRC2011 - 19-06
- Status last verified
- Nov 2015
- First submitted
- 25 Apr 2013
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Lampin ME, Duhamel A, Behal H, Leteurtre S, Leclerc F, Recher M. Patient Characteristics and Severity Trajectories in a Pediatric Intermediate Care Unit. Indian J Pediatr. 2025 Feb;92(2):150-156. doi: 10.1007/s12098-023-04902-4. Epub 2023 Nov 16.
PubMed 37971648
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study.
- ClinicalTrials.gov ID
- NCT02304341
- Acronym / sponsor ID
- 2011_20
- Conditions
- Critical Illness
- Keywords
- critical illness, disease progression, child, severity of illness index, monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,016 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Sep 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Dec 2014 (estimated)
- 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.
Children are admitted in intermediate units when the severity requires continuous monitoring. In France, Resources allocated to intermediate units are determined from lists of diagnoses and associated acts to additional budget. A score to assess the severity of illness may be associated with acts to develop an activity indicator easy to use. The investigators have chosen 2 scores to assess severity in intermediate cares : the Paediatric Advanced Warning Score (PAWS) and the Bedside Pediatric Early System Score (PEWS). In France, they have not been validated. The correlation between the severity of children and the associated diagnoses and acts has not been studied. The main objective of this study is to validate these 2 scores. The secondary objective is to determine a simplified activity indicator.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intermediate units | – | –Children admitted to the paediatric inpatient unit in 7 regional hospitals French |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to the paediatric inpatient unit in 7 regional hospitals French
Key inclusion criteria (1 listed)
- All children admitted to the paediatric inpatient unit
Key exclusion criteria (1 listed)
- parental refusal
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
Changed inPaediatric Advanced Warning Score (PAWS)
Time frame: at admission and each 8 hours, up to 5 days
Temperature, Capillary Refill Time (CRT), respiratory rate, heart rate,neurological status, oxygen saturation, respiratory distress measure at admission, each 8 hours and if deteriorations
2 secondary outcomes
Changed in Pediatric Early Warning System score (PEWS)
Time frame: at admission and each 8 hours, up to 5 days
Transfer in pediatric intensive care (YES/NO)
Time frame: at each 8 hours, up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 37971648Lampin ME, Duhamel A, Behal H, Leteurtre S, Leclerc F, Recher M. Patient Characteristics and Severity Trajectories in a Pediatric Intermediate Care Unit. Indian J Pediatr. 2025 Feb;92(2):150-156. doi: 10.1007/s12098-023-04902-4. Epub 2023 Nov 16.
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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. This study is not recruiting at the moment.
Stephane LETEURTRE, MD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by University Hospital, Lille at 7 sites in France.
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: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed inPaediatric Advanced Warning Score (PAWS) (time frame: at admission and each 8 hours, up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02304341, which also lists 1 linked publication.
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 Apr 2026.