Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E.
ERNIE3
1 other identifier
observational
1,500
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
1 active site
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
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedSeptember 14, 2012
September 1, 2012
1.1 years
July 18, 2011
September 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Children with an acute illness
Children aged 1 month to 16 years of age, which attend the A\&E department of UZLeuven with an acute illness episode of maximum 5 days.
Eligibility Criteria
Children aged 1 month to 16 years, attending the A\&E department of the UZLeuven Hospital with an acute illness episode of maximum 5 days
You may qualify if:
- Children aged 1 month to 16 years
- Acute illness episode of maximum 5 days
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
Dienst Algemene Kindergeneeskunde, Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Related Publications (2)
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.
PMID: 20132979BACKGROUNDVan 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.
PMID: 17727746BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan YJ Verbakel, M.D.
KU Leuven
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jan Verbakel, M.D.
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 19, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
September 14, 2012
Record last verified: 2012-09