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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02304341
• Other study ID #: 2011_20
• Secondary ID: PHRC2011 - 19-06
• Status: Completed
• Phase: N/A
• First received: April 25, 2013
• Last updated: November 2, 2015
• Start date: September 2012
• Est. completion date: January 2015

Study information

• Verified date: November 2015
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3016
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• All children admitted to the paediatric inpatient unit

Exclusion Criteria:

• parental refusal

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
France	Centre Hospitalier Général	Arras
France	Centre hospitalier général	Boulogne sur mer
France	Centre Hospitalier Général	Cambrai
France	Centre Hospitalier Général	Douai
France	Centre Hospitalier général	Dunkerque
France	Centre Hospitalier Général	Lens
France	Centre Hospitalier Général	Roubaix

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	at admission and each 8 hours, up to 5 days	No
Secondary	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	at each 8 hours, up to 5 days	No