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Validation of Vital Signs and Symptoms for the Diagnosis of Serious Infections in Children in the Paediatric A&E. (ERNIE3)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396798
First Posted: July 19, 2011
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jan Verbakel, Katholieke Universiteit Leuven
  Purpose
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.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Jan Verbakel, Katholieke Universiteit Leuven:

Primary Outcome Measures:
  • serious infections: meningitis, sepsis, pneumonia, pyelonephritis, osteomyelitis and cellulitis, gastroenteritis with sever dehydration, complicated urinary tract infection and complicated viral airway infection with hypoxia. [ Time Frame: within 24 hours after assessment ]

Enrollment: 1500
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396798


Locations
Belgium
Dienst Algemene Kindergeneeskunde, Universitaire Ziekenhuizen Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Katholieke Universiteit Leuven
Investigators
Principal Investigator: Jan YJ Verbakel, M.D. Katholieke Universiteit Leuven
  More Information

Publications:
Responsible Party: Jan Verbakel, Jan Verbakel, M.D., Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01396798     History of Changes
Other Study ID Numbers: S52996
First Submitted: July 18, 2011
First Posted: July 19, 2011
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by Jan Verbakel, Katholieke Universiteit Leuven:
serious infections
meningitis

Additional relevant MeSH terms:
Infection
Communicable Diseases
Urinary Tract Infections
Meningitis
Respiratory Tract Infections
Gastroenteritis
Signs and Symptoms
Community-Acquired Infections
Urologic Diseases
Central Nervous System Diseases
Nervous System Diseases
Respiratory Tract Diseases
Gastrointestinal Diseases
Digestive System Diseases