USING A DECISION-MAKING SYSTEM TO SUPPORT THE MANAGEMENT OF FEVER AND ACUTE PAIN IN CHILDREN
PREMARKET INVESTIGATION ON THE USE OF A DIGITAL DECISION-MAKING AID AIMED AT IMPROVING THE APPROPRIATENESS AND ADHERENCE TO THERAPY FOR THE MANAGEMENT OF FEVER AND ACUTE PAIN IN PATIENTS BETWEEN 3 MONTHS AND 1 DAY AND 5 YEARS OF AGE
Qwince Innovation S.r.l.
100 participants
Dec 28, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have a fever and are prescribed paracetamol, or who have already received a prescription for an antipyretic from an outside physician before accessing the emergency room.
- Pediatric patients, male or female, between 3 months and 1 day and 5 years of age, who have acute pain and are prescribed paracetamol, or who have already received a prescription for an analgesic from an outside physician before accessing the emergency room.
- Pediatric patients whose caregivers have knowledge of the Italian language.
- Pediatric patients whose caregivers have access to the internet and have a smartphone that is either the latest generation or no older than five years.
Exclusion Criteria4
- Pediatric patients, male or female, aged less than 3 months and over 5 years.
- Pediatric patients who have experienced adverse reactions or contraindications to paracetamol administration.
- Pediatric patients whose caregivers have little or no knowledge of the Italian language.
- Pediatric patients whose caregivers do not have internet access or do not have a latest-generation smartphone or, in any case, one no older than five years.
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Interventions
Puntofarma® is a software-based medical device, which the manufacturer intends to use in standalone mode, with the aim of improving prevention, monitoring, and patient care processes. In the context of the FEVER clinical trial, it is designed to: * acquire and organize pediatric patient health information (measurements, parameters); * assist caregivers/parents in managing fever/acute pain, including through alarms and reminders; * create a communication channel between caregivers/parents and healthcare professionals. The clinically relevant features of Puntofarma® for the FEVER study are as follows: * collect data regarding the patient's health and treatment status; * enable the collection of data relating to episodes of fever and/or acute pain (Fever Diary, Pain Diary, and Other Events/Symptoms Diary); * manage the Fever Diary and Pain Diary, therapy planning, and therapeutic reconnaissance (for appropriateness purposes).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07344090