The Naples Pediatric Food Allergy (NAPFA) Score

NCT05707858 | Completed DMC

• 1 other identifier: 284/21
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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

Keywords

Food allergy

Outcome Measures

Primary Outcomes (1)

• Development of a new clinical score for the identification of pediatric FA in primary care setting

  The score will include the main anamnestic and clinical features

  at the enrollment

Secondary Outcomes (2)

• Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting

  at the enrollment

• Validation of the new clinical NAPFA score for the identification of pediatric FA

  at the enrollment

Study Arms (1)

Subject with suspected food allergy

Other: Development of the NAPFA score

Interventions

Development of the NAPFA score OTHER

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

Subject with suspected food allergy

Eligibility Criteria

• Age: 1 Week - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged 0-14 years with suggestive history of food allergy

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Roberto Berni Canani, MD

  Department of Translational Medical Science, University of Naples Federico II

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: January 23, 2023
• Primary Completion: June 22, 2023
• Study Completion: December 20, 2023
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

IT (1)