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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:
Information provided by (Responsible Party):
Jan Verbakel, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier:
NCT01396798
First received: July 18, 2011
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: July 18, 2011
Last Updated: September 13, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by Katholieke Universiteit Leuven:
serious infections
meningitis

Additional relevant MeSH terms:
Gastroenteritis
Meningitis
Respiratory Tract Infections
Sepsis
Signs and Symptoms
Urinary Tract Infections
Community-Acquired Infections
Gastrointestinal Diseases
Digestive System Diseases
 Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Infection
Respiratory Tract Diseases
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013