Febrile Infants - Diagnostic Assessment and Outcome (FIDO)
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|ClinicalTrials.gov Identifier: NCT04196192|
Recruitment Status : Completed
First Posted : December 12, 2019
Last Update Posted : May 11, 2021
The purpose of this study is to assess how clinicians apply guidance in the assessment of febrile infants presenting the the Emergency Department. The measurable outcomes are:
Primary Objective Report the rates of serious and invasive bacterial infections in febrile infants
Secondary Objectives Report on the predictive value of different clinical features for predicting bacterial infections.
Report on the value of biomarkers for predicting serious and invasive bacterial infections.
Assess the performance of clinical practice guidelines for the assessment of febrile infants.
|Condition or disease|
|Meningitis, Bacterial Bacterial Infections Urinary Tract Infections|
The assessment of febrile infants is difficult. In the UK and Ireland current guidance advocates that most children under 3 months of age with a fever undergo a full septic screen including lumbar puncture and receive parenteral antibiotics. Approaches in the United States and Europe including the PECARN and StepByStep approach allow for the discharge home of some low risk young infants.
We intend to assess the current approach to febrile infants and compare that to the available clinical practice guidelines. We also intend to determine which clinical and/or laboratory features are most predictive of serious bacterial infection.
|Study Type :||Observational|
|Actual Enrollment :||555 participants|
|Official Title:||Febrile Infants - Diagnostic Assessment and Outcome|
|Actual Study Start Date :||March 1, 2020|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||May 1, 2021|
All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source.
- Invasive bacterial infection [ Time Frame: seven days ]Invasive Bacterial Infection (non-contaminant) confirmed by culture or molecular diagnostic testing of a sterile site i.e. blood or cerebrospinal fluid (CSF). Staphylococcus epidermidis, Propionibacterium acnes, Streptococcus viridans, or Diphtheroides were considered contaminants.
- Serious bacterial infections [ Time Frame: seven days ]Urinary tract infections defined as growth of ≥100 000 cfu/mL
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): NCT04196192
|Children's Health Ireland|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT126BE|
|Bristol Royal Children's Hospital|
|Bristol, United Kingdom|
|Royal Hospital for Children Glasgow|
|Glasgow, United Kingdom|
|Leicester Royal Infirmary|
|Leicester, United Kingdom|
|Royal London Hospital|
|London, United Kingdom|