Investigators: Ariel Mace, James Totterdell, Jessica Ramsay, Julie Marsh, Tom Snelling
External collaborators: Andrew Martin (Perth Children's Hospital), Sarah Cherian (Perth Children's Hospital), Janine Spencer (Fiona Stanley Hospital), Briony Hazelton (PathWest Laboratory Medicine), Paul Ingram (PathWest Laboratory Medicine)
FeBRILe3 is a prospective pragmatic, multi-site safety assessment, observational study and impact project. It will evaluate the safety of a clinical practice guideline which allows febrile infants fulfilling low-risk criteria to be discharged early from hospital if their blood cultures demonstrate no growth at 24 hours (compared to previous minimum 48-hour admission).
This guideline has been implemented at two Western Australian metropolitan hospitals. Infants aged <3 months (chronological or corrected for premature birth before 37 weeks gestation) presenting with fever without source will be included. The primary outcome is readmission to hospital due to clinical deterioration/care-giver concern within 7 days of discharge. This will be identified through review of electronic admission details and study-specific care-giver surveys.
Secondary outcomes include rates of serious bacterial infection, hospital lengths of stay compared to previous practice and to assess clinician guideline adherence, and care-giver satisfaction with the discharge process. Analysis will be within a sequential Bayesian safety monitoring framework, which incorporates new information and updates the evidence for guideline safety relative to previous practice (historical control) at pre-specified interim analyses.