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NCT01396798 Clinical Trial

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.

Sepsis Clinical Trial

— ERNIE3  

Official title:
Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in a High Prevalent Setting: the Paediatric A&E.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01396798
Other study ID # S52996
Secondary ID
Status Completed
Phase N/A
First received July 18, 2011
Last updated September 13, 2012
Start date February 2011
Est. completion date March 2012

Study information
Verified date September 2012
Source Katholieke Universiteit Leuven
Contact n/a
Is FDA regulated No
Health authority Belgium: Ethics Committee
Study type Observational

Clinical Trial Summary

Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Acutely Ill Children in a High Prevalent Setting: The Paediatric Accidents & Emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. Eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.

Recruitment information / eligibility
Status Completed
Enrollment 1500
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 16 Years
Eligibility Inclusion Criteria:

- Children aged 1 month to 16 years

- Acute illness episode of maximum 5 days

Exclusion Criteria:

- recent trauma

- neurological conditions

- intoxication

- psychiatric of behavioural disorders without a somatic cause

- acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Belgium Dienst Algemene Kindergeneeskunde, Universitaire Ziekenhuizen Leuven Leuven Vlaams-Brabant

Sponsors (1)
Lead Sponsor Collaborator
Katholieke Universiteit Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

Van den Bruel A, Aertgeerts B, Bruyninckx R, Aerts M, Buntinx F. Signs and symptoms for diagnosis of serious infections in children: a prospective study in primary care. Br J Gen Pract. 2007 Jul;57(540):538-46. — View Citation

Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary serious infections: meningitis, sepsis, pneumonia, pyelonephritis, osteomyelitis and cellulitis, gastroenteritis with sever dehydration, complicated urinary tract infection and complicated viral airway infection with hypoxia. within 24 hours after assessment No
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