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Search / Trial NCT07134751

Febrile Infants Swedish Study

Launched by REGION SKANE · Aug 14, 2025

Trial Information

Current as of August 24, 2025

Not yet recruiting

Keywords

Guidelines Febrile Infants Age ≤60 Days Management Serious Bacterial Infections Invansive Bacterial Infections Clinical Prediction Tool

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported