Febrile Infants - Diagnostic Assessment and Outcome (FIDO)

Belfast Health and Social Care Trust

Status: Completed

Conditions: Urinary Tract Infections; Meningitis, Bacterial; Bacterial Infections

Study type: Observational

Funder types: Other

Identifiers

NCT04196192

QIP10/12/19HJ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 555 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

555 participants in 1 patient group

Group 1

Description:

All infants aged 0-90 days (inclusive) undergoing routine assessments for fever without source.