Decision-making app to guide fever and acute pain care in young 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
This will try a smartphone app that uses an algorithm to help caregivers of children aged 3 months to 5 years give paracetamol correctly for fever or acute pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 3 Months to 5 Years |
| Sex | All |
| Sponsor | Qwince Innovation S.r.l. Industry-sponsored |
| Locations | 1 site (Florence, Italy) |
| Trial ID | NCT07344090 on ClinicalTrials.gov |
What this trial studies
FEVER is a single-center, prospective, open-label, pre-market, pivotal, single-arm study testing an algorithm embedded in the Puntofarma® medical device delivered via a smartphone app to guide paracetamol use in children aged 3 months to 5 years. Up to 100 patients will be enrolled at discharge from the pediatric emergency department at Meyer University Children’s Hospital, split evenly between fever and acute pain presentations, and each caregiver will use the app for up to seven days. The algorithm was built from therapeutic guidelines to generate dosing and timing recommendations based on caregiver input, and the system is designed so no personal patient data are stored on the device. The study will track adherence and appropriateness of paracetamol administration to see if the app improves real-world dosing and therapy adherence.
Who should consider this trial
Good fit: Children aged 3 months to 5 years presenting to the pediatric emergency department with fever or acute pain whose caregivers speak Italian and have an internet-connected smartphone (no older than five years) are ideal candidates.
Not a fit: Children with contraindications or prior adverse reactions to paracetamol, those younger than 3 months or older than 5 years, caregivers without Italian language skills or a compatible smartphone/internet access, or patients needing inpatient care are unlikely to benefit from this app.
Why it matters
Potential benefit: If successful, the app could improve correct dosing and adherence to paracetamol, reducing under- or overdosing and improving symptom control in young children.
How similar studies have performed: Guideline-based digital dosing tools have shown improvements in caregiver adherence in prior studies, but use of a Class I device app specifically for paracetamol dosing in this exact pediatric age range is relatively novel and not extensively validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Florence, Italy
- Meyer University Children's Hospital Florence — Florence, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Niccolò Parri, MD, Pediatric Emergency — Meyer University Children's Hospital Florence, Department of Emergency Medicine and Trauma Center, ITALY
- Study coordinator: Laura Villani, M.Sc.
- Email: lvillani@cvbf.net
- Phone: +39 0382 1475411
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.