Actively Recruiting
USING A DECISION-MAKING SYSTEM TO SUPPORT THE MANAGEMENT OF FEVER AND ACUTE PAIN IN CHILDREN
Led by Qwince Innovation S.r.l. · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
Q
Qwince Innovation S.r.l.
Lead Sponsor
C
Consorzio per Valutazioni Biologiche e Farmacologiche
Collaborating Sponsor
AI-Summary
What this Trial Is About
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study aimed at demonstrating how the use of an algorithm integrated with a Class I Medical Device (Puntofarma®), which is made available through a downloadable mobile phone app, can, given specific input, improve the appropriateness and adherence to therapy for the management of fever and pain in children between 3 months and 1 day and 5 years of age. 100 patients are expected to be enrolled, equally distributed between febrile patients (50%) and patients with acute pain (50%). Patients admitted to the Regional Pediatric Emergency Department of the Meyer IRCCS Hospital in the presence of a feverish episode and/or acute pain will be enrolled upon discharge. The study will last a total of 8 months (Jan - Aug 2026), with enrollment expected by Jan 2026. Each patient will be involved in the study for a maximum of 7 days from enrollment, during which they will use the mobile app. Participation in the study will conclude by the seventh day of use of the app, with the completion of a satisfaction questionnaire.
CONDITIONS
Official Title
USING A DECISION-MAKING SYSTEM TO SUPPORT THE MANAGEMENT OF FEVER AND ACUTE PAIN IN CHILDREN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients aged between 3 months and 5 years
- Patients with fever prescribed paracetamol or with an existing antipyretic prescription before emergency room admission
- Patients with acute pain prescribed paracetamol or with an existing analgesic prescription before emergency room admission
- Caregivers able to understand Italian
- Caregivers with internet access and a smartphone no older than five years
You will not qualify if you...
- Patients younger than 3 months or older than 5 years
- Patients with a history of adverse reactions or contraindications to paracetamol
- Caregivers with little or no knowledge of Italian
- Caregivers without internet access or a smartphone older than five years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Meyer University Children's Hospital Florence
Florence, Italy, Italy, 50139
Actively Recruiting
Research Team
L
Laura Villani, M.Sc.
CONTACT
S
Stefania Quintavalle, PharmD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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