Approximately one million febrile infants aged ≤60 days present annually to pediatric emergency departments (PEDs) in Europe and the United States. Although fewer than 5% are diagnosed with meningitis or bacteremia (invasive bacterial infections - IBIs), and 10-15% with urinary tract infections (UTIs), current guidelines recommend extensive diagnostic evaluations, hospitalization, and empirical treatment with broad-spectrum parenteral antibiotics. This approach may contribute to medical overuse, with implications for patient care, healthcare resource utilization, and environmental sustainability.
The Febrile Infants Swedish Study (FISS) is a prospective observational study conducted across 11 PEDs in Sweden. All febrile infants aged ≤60 days presenting to participating sites will be eligible. A new clinical guideline for the management of infants with fever without source (FWS) will be implemented in 7 PEDs, while 4 PEDs will continue with current standard practice and serve as a comparison group.
The study is expected to run for approximately two years and aims to recruit a minimum of 2,500 febrile infants
Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)
Age ≤60 days
None
All febrile infants aged ≤60 days brought to any of the study Pediatric Emergency Departments will be considered eligible for the study.
Cohort
Prospective
Not listed
The proportion of febrile infants aged ≤60 days with meningitis, bacteremia, and urinary tract infection identified by the new guideline and the proportion of those that received treatment with delay.
The proportion of investigations, antibiotic treatments, and hospitalizations among febrile infants aged ≤60 days who visited the PED.
The prevalence of meningitis, bacteremia, and urinary tract infection among febrile infants aged ≤60 days.
Duration and height of the fever, gestational age, birth weight, breastfeeding, clinical signs and symptoms, and laboratory results.
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