New care guideline for infants 60 days and younger with fever in Sweden
Febrile Infants Swedish Study
This project will test a new guideline to see if infants 60 days or younger with fever can safely avoid many invasive tests, hospital stays, and broad antibiotics compared with usual care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | N/A to 60 Days |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 11 sites (Gothenburg and 10 other locations) |
| Trial ID | NCT07134751 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational implementation across 11 pediatric emergency departments in Sweden. Seven sites will introduce a new clinical guideline for fever without source in infants ≤60 days, while four sites will continue standard practice to provide a comparison. All febrile infants aged ≤60 days presenting with temperature ≥38.0°C are eligible and will be followed for diagnostic testing, hospital admissions, antibiotic use, and missed invasive bacterial infections. The design aims to measure real-world safety, resource use, and potential reductions in unnecessary care.
Who should consider this trial
Good fit: Ideal candidates are infants aged 60 days or younger who present with a fever of at least 38.0°C to one of the participating pediatric emergency departments in Sweden.
Not a fit: Infants who already have clear signs of serious bacterial infection, are older than 60 days, or present to non-participating hospitals are unlikely to gain benefit from this guideline.
Why it matters
Potential benefit: If successful, the guideline could reduce unnecessary procedures, hospital admissions, and early antibiotic exposure for many young infants with fever.
How similar studies have performed: Previous research shows that risk-stratified algorithms can reduce testing and antibiotic use in some infant groups, but large multicenter implementations of a new guideline like this are relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Temperature ≥38.0 C (measured either at home or at the pediatric emergency department) * Age ≤60 days
Where this trial is running
Gothenburg and 10 other locations
- Sahlgrenska University Hospital — Gothenburg, Sweden (Recruiting)
- Helsingborg Hospital — Helsingborg, Sweden (Not_yet_recruiting)
- Ryhov County Hospital — Jönköping, Sweden (Recruiting)
- Kristianstad Central Hospital — Kristianstad, Sweden (Recruiting)
- Skåne University Hospital — Lund, Sweden (Recruiting)
- Skåne University Hospital — Malmö, Sweden (Recruiting)
- Örebro University Hospital — Örebro, Sweden (Recruiting)
- Karolinska University Hospital — Stockholm, Sweden (Recruiting)
- Sachs' Children and Youth Hospital — Stockholm, Sweden (Not_yet_recruiting)
- Uppsala University Hospital — Uppsala, Sweden (Recruiting)
- Ystad Hospital — Ystad, Sweden (Recruiting)
Study contacts
- Study coordinator: Ioannis Orfanos, Senior Consultant
- Email: ioannis.orfanos@med.lu.se
- Phone: +4646178225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.