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

NCT07344090 | Recruiting

• 2 other identifiers: ID-CE-29153EUDAMED Number 25-10-054835
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fever, Acute Pain

Keywords

fever, acute pain, pediatrics

Outcome Measures

Primary Outcomes (1)

• Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.

  Measurement of adherence to the prescribed dosage of paracetamol during the treatment cycle.

  8 days of treatment

Secondary Outcomes (4)

• Evaluation of the consistency of the timing of paracetamol administration during the treatment period

  8 days of intervention

• Digital app usage rate: Percentage of parents/caregivers using the digital app

  8 days of intervention

• Number (%) of patients taking ibuprofen

  8 days of intervention

• Caregiver satisfaction

  8 days of intervention

Study Arms (1)

Intervention arm

EXPERIMENTAL

After signing the informed consent, the patient and caregiver will be enrolled in the study and registered in the Puntofarma® system, resulting in the issuance of a unique code. No personal data of the patient and/or caregiver will be recorded on the device. At the same time, a PIN code will be issued for each enrolled patient, allowing the caregiver to register in the digital application and begin using the algorithm from their mobile/digital device. Caregivers will be required to enter the necessary information into the application so that the algorithm can calculate the recommended dose of paracetamol. The application, which can be downloaded to a mobile phone, is used to verify adherence to the antipyretic therapy suggested by the algorithm and based on the guidelines for the management of fever and acute pain in children.

Device: Puntofarma® FEVER

Interventions

Puntofarma® FEVER DEVICE

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).

Intervention arm

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qwince Innovation S.r.l.: lead
• Consorzio per Valutazioni Biologiche e Farmacologiche: collaborator

Study Sites (1)

Meyer University Children's Hospital Florence

Florence, Italy, 50139, Italy

RECRUITING

MeSH Terms

Conditions

Fever; Acute Pain

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Niccolò Parri, MD, Pediatric Emergency

  Meyer University Children's Hospital Florence, Department of Emergency Medicine and Trauma Center, ITALY

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Villani, M.Sc.

CONTACT

+39 0382 1475411; lvillani@cvbf.net

Stefania Quintavalle, PharmD

CONTACT

+39 080 9751974; squintavalle@cvbf.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: December 28, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

IT (1)