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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Community-Acquired Infections Respiratory Tract Infections Sepsis Urinary Tract Infections Meningitis Gastroenteritis

Keywords

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serious infections meningitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jan Verbakel

Jan Verbakel, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan YJ Verbakel, M.D.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

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Dienst Algemene Kindergeneeskunde, Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND

PMID: 20132979 (View on PubMed)

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.