The Naples Pediatric Food Allergy (NAPFA) Score

NCT ID: NCT05707858

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2023-12-20

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.

Conditions

Food Allergy in Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Subject with suspected food allergy

Development of the NAPFA score

Intervention Type: OTHER

In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score

Interventions

Development of the NAPFA score

In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Roberto Berni Canani, MD, PhD

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roberto Berni Canani, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Translational Medical Science, University of Naples Federico II

Locations

Department of Traslational Medical Science - University of Naples Federico II

Naples, , Italy

Countries

Italy

Other Identifiers

284/21

Identifier Type: -

Identifier Source: org_study_id