USING A DECISION-MAKING SYSTEM TO SUPPORT THE MANAGEMENT OF FEVER AND ACUTE PAIN IN CHILDREN

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.

NCT Number	NCT07344090
Lead Sponsor	Qwince Innovation S.r.l. Collaborators: Consorzio per Valutazioni Biologiche e Farmacologiche
Conditions	Fever, Acute Pain
Enrollment	100 participants
Start Date	2025-12-28
Primary Completion	2026-05-30 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2026-01-15