Development of a Modified Pediatric Early Warning Score: a French Prospective Multicentre Regional Study

Completed

• Conditions: Critical Illness

• Registration Number: NCT02304341
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-04-25
• Primary Completion: 2014-01
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-12-01
• Study Completion: 2015-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3016

Inclusion Criteria

• All children admitted to the paediatric inpatient unit

Exclusion Criteria

• parental refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changed inPaediatric Advanced Warning Score (PAWS)	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

Secondary Outcome Measures

Name	Time	Method
Changed in Pediatric Early Warning System score (PEWS)	at admission and each 8 hours, up to 5 days	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
Transfer in pediatric intensive care (YES/NO)	at each 8 hours, up to 5 days	this secondary outcome is evaluated when the bedPEWS and PAWS scores are collected : at admission, each 8 hours and if deterioration

Trial Locations

Locations (3)

Centre Hospitalier Général; 🇫🇷 Roubaix, France

Centre hospitalier général; 🇫🇷 Boulogne sur mer, France

Centre Hospitalier général; 🇫🇷 Dunkerque, France