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

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.

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Key information

Conditions

Community-Acquired Infections Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infections Inflammation Male Urogenital Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Sepsis Systemic Inflammatory Response Syndrome Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dienst Algemene Kindergeneeskunde, Universitaire Ziekenhuizen Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Registry information

Official study title

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

Acronym: ERNIE3

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Jul 19, 2011
Registry last updated: Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed