Actively Recruiting
Febrile Infants Swedish Study Evaluating a New Clinical Guideline for Fever Management in Infants 60 Days or Younger
Led by Region Skane · Updated on 2026-04-02
2000
Participants Needed
11
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the management of febrile infants aged 60 days or younger who visit pediatric emergency departments (PEDs) in Sweden. The study evaluates a new clinical guideline compared to current standard practices across 11 PEDs. This observational study aims to improve care by reducing unnecessary diagnostic tests, hospitalizations, and broad-spectrum antibiotic use, which have implications for patient comfort, healthcare resources, and environmental impact. The study will implement the new guideline in 7 PEDs while 4 PEDs will continue their usual care as a control group. All febrile infants aged 60 days or younger with a body temperature of 38.0°C or higher, measured at home or in the PED, will be included. The research collects clinical data including fever details, gestational age, birth weight, symptoms, lab results, and diagnoses to refine and personalize management recommendations. Participants will be observed during their visit to the PED, with data gathered on investigations, treatments, and hospitalizations. The primary measure is how effectively the new guideline identifies cases of meningitis, bacteremia, and urinary tract infections, including any delays in treatment, tracked over 10 days. Secondary measures include prevalence of infections, clinical signs, and adherence to the guideline. The study plans to enroll at least 2,500 infants over approximately two years, with careful monitoring of outcomes and resource use.
CONDITIONS
Brief Title
Febrile Infants Swedish Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Temperature of 38.0°C or higher measured at home or at the pediatric emergency department
- Age 60 days or younger
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1
Participants undergo clinical and laboratory assessments to evaluate fever without a source and identify possible serious bacterial infections.
1 visit (in-person)
Duration - 10 days
Participants are observed to collect data on fever duration and height, clinical symptoms, and treatment outcomes over 10 days.
Follow-up contacts during 10 days of attendance
Trial Site Locations
Total: 11 locations
1
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
2
Helsingborg Hospital
Helsingborg, Sweden
Not Yet Recruiting
3
Ryhov County Hospital
Jönköping, Sweden
Actively Recruiting
4
Kristianstad Central Hospital
Kristianstad, Sweden
Actively Recruiting
5
Skåne University Hospital
Lund, Sweden
Actively Recruiting
6
Skåne University Hospital
Malmö, Sweden
Actively Recruiting
7
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
8
Karolinska University Hospital
Stockholm, Sweden
Actively Recruiting
9
Sachs' Children and Youth Hospital
Stockholm, Sweden
Not Yet Recruiting
10
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
11
Ystad Hospital
Ystad, Sweden
Actively Recruiting
Research Team
I
Ioannis Orfanos, Senior Consultant
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here