Trial Information
Current as of August 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This study, called the Febrile Infants Swedish Study (FISS), is looking at how to best care for very young babies (60 days old or younger) who have a fever without a clear cause. Right now, many babies with a fever are given lots of tests, often stay in the hospital, and receive strong antibiotics just in case they have a serious infection like meningitis or a bloodstream infection. However, these serious infections are actually quite rare. The study will compare a new way of managing these febrile babies in some hospitals to the usual care used in others, to see if the new approach can reduce unnecessary tests and treatments while keeping babies safe.
Babies eligible for this study are those who are 60 days old or younger and have a fever of 38.0°C (100.4°F) or higher, whether the fever was measured at home or in the emergency department. If a baby takes part, their doctors will follow either the new guideline or the usual care depending on the hospital. The study will include at least 2,500 babies over about two years and is being done in 11 pediatric emergency departments across Sweden. This research hopes to find better ways to care for febrile infants that avoid extra hospital stays and treatments, making care safer and less stressful for families.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Temperature ≥38.0 C (measured either at home or at the pediatric emergency department)
- • Age ≤60 days
About Region Skane
Region Skåne is a leading healthcare authority in Sweden, dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and patients, Region Skåne aims to enhance the understanding of various health conditions and develop effective treatment strategies. With a focus on ethical standards and patient safety, the organization plays a pivotal role in shaping the future of healthcare in the region and beyond, ensuring that clinical trials are conducted with the highest level of scientific rigor and transparency.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Uppsala, , Sweden
Göteborg, , Sweden
Stockholm, , Sweden
Ystad, , Sweden
örebro, , Sweden
Helsingborg, , Sweden
Lund, , Sweden
Malmö, , Sweden
Kristianstad, , Sweden
Jönköping, , Sweden
Stockholm, , Sweden
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported