NCT02304341

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,016

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 22, 2026

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

April 25, 2013

Last Update Submit

April 17, 2026

Conditions

Keywords

critical illnessdisease progressionchildseverity of illness indexmonitoring

Outcome Measures

Primary Outcomes (1)

  • 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

    at admission and each 8 hours, up to 5 days

Secondary Outcomes (2)

  • Changed in Pediatric Early Warning System score (PEWS)

    at admission and each 8 hours, up to 5 days

  • Transfer in pediatric intensive care (YES/NO)

    at each 8 hours, up to 5 days

Study Arms (1)

intermediate units

Children admitted to the paediatric inpatient unit in 7 regional hospitals French

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children admitted to the paediatric inpatient unit in 7 regional hospitals French

You may qualify if:

  • All children admitted to the paediatric inpatient unit

You may not qualify if:

  • parental refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Centre Hospitalier Général

Arras, France

Location

Centre hospitalier général

Boulogne-sur-Mer, France

Location

Centre Hospitalier Général

Cambrai, France

Location

Centre Hospitalier Général

Douai, France

Location

Centre Hospitalier général

Dunkirk, France

Location

Centre Hospitalier Général

Lens, France

Location

Centre Hospitalier Général

Roubaix, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Critical IllnessDisease Progression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephane LETEURTRE, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

December 1, 2014

Study Start

September 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2015

Last Updated

April 22, 2026

Record last verified: 2015-11

Locations