Skip to content

Febrile Infants - Diagnostic Assessment and Outcome

Febrile Infants - Diagnostic Assessment and Outcome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04196192
Acronym
FIDO
Enrollment
555
Registered
2019-12-12
Start date
2020-03-01
Completion date
2021-05-01
Last updated
2021-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections, Meningitis, Bacterial, Urinary Tract Infections

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Bristol Royal Hospital for Children
CollaboratorOTHER
University Hospitals, Leicester
CollaboratorOTHER
Barts & The London NHS Trust
CollaboratorOTHER
Children's Health Ireland
CollaboratorOTHER_GOV
Royal Hospital for Children Glasgow
CollaboratorUNKNOWN
Royal Belfast Hospital for Sick Children
CollaboratorUNKNOWN
Belfast Health and Social Care Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 90 Days

Inclusion criteria

* Any infant aged 0 to 90 days (inclusive) with a fever of 38 degrees centigrade or higher recorded in the Emergency Department.

Design outcomes

Primary

MeasureTime frameDescription
Invasive bacterial infectionseven daysInvasive 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 infectionsseven daysUrinary tract infections defined as growth of ≥100 000 cfu/mL

Countries

Ireland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026