Actively Recruiting

Age: 0 - 60Days
All Genders
ID07134751

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

Age: 0 - 60Days
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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)

Monitoring

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

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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

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