The Naples Pediatric Food Allergy (NAPFA) Score

Completed

• Conditions: Food Allergy in Children
• Interventions: Other: Development of the NAPFA score

• Registration Number: NCT05707858
• Lead Sponsor: Federico II University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-02-01
• Primary Completion: 2023-06-22
• Study Completion: 2023-12-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-10
• Last Update Posted: 2025-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subject with suspected food allergy	Development of the NAPFA score	-

Primary Outcome Measures

Name	Time	Method
Development of a new clinical score for the identification of pediatric FA in primary care setting	at the enrollment	The score will include the main anamnestic and clinical features

Secondary Outcome Measures

Name	Time	Method
Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting	at the enrollment	The score will include the main anamnestic and clinical features
Validation of the new clinical NAPFA score for the identification of pediatric FA	at the enrollment	Validation of the score on pediatric subject with suspected FA

Trial Locations

Locations (1)

Department of Traslational Medical Science - University of Naples Federico II; 🇮🇹 Naples, Italy