The Naples Pediatric Food Allergy (NAPFA) Score

Federico II University

Status: Completed

Conditions: Food Allergy in Children

Treatments: Other: Development of the NAPFA score

Study type: Observational

Funder types: Other

Identifiers

NCT05707858

284/21

Details and patient eligibility

About

Food Allergy (FA) is one of the most expensive allergic disorders in the pediatric age, and affecting up to 10% of children worldwide, it is recognized as a global health problem. The Oral Food Challenge (OFC) is the gold standard for FA diagnosis, but it is time-consuming, expensive, and potentially dangerous, as it can determine severe anaphylaxis. In addition, causing long-lasting impact on patient anxiety and mental health due to the physical duress and health risks involved with its application, OFC strategy is little applied in clinical practice with consequent diagnostic errors and delays. The goal of the Naples Pediatric Food Allergy (NAPFA) score is to develop a new clinical score including the main anamnestic, and clinical features for the easy identification of pediatric FA in primary care setting.

Enrollment: 600 patients

Sex: All

Ages: 1 week to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects aged between 0-14 years with suggestive history of food allergy

Exclusion criteria

• Exclusion criteria: age >14 years
• chronic systemic diseases,
• malignancy,
• immunodeficiency,
• infectious diseases,
• autoimmune diseases,
• inflammatory bowel diseases,
• celiac disease,
• metabolic and genetic diseases,
• cystic fibrosis,
• chronic pulmonary diseases,
• gastrointestinal, respiratory, urinary tract and/or cardiovascular malformations,
• neurologic and/or neuropsychiatric disorders,
• gastrointestinal tract eosinophilic disorders,
• use of immunomodulating drugs in the previous 4 months
• use of steroids and antihistamines in the previous 2 weeks

Trial design

600 participants in 1 patient group

Subject with suspected food allergy

Treatment:

Other: Development of the NAPFA score