The Naples Pediatric Food Allergy (NAPFA) Score (NAPFA)

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.

Study Overview

• Status: Recruiting
• Conditions: Food Allergy in Children
• Intervention / Treatment: Other: Development of the NAPFA score

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Roberto Berni Canani, MD; Phone Number: 0817462680; Email: berni@unina.it

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Department of Traslational Medical Science - University of Naples Federico II
    • Contact: Roberto Berni Canani, MD, PhD; Phone Number: 0817462680; Email: berni@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 14 years (Child)
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subject with suspected food allergy	Other: Development of the NAPFA score; In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting	The score will include the main anamnestic and clinical features	at the enrollment

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Roberto Berni Canani, MD, Department of Translational Medical Science, University of Naples Federico II

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2023
• Primary Completion (Actual): June 22, 2023
• Study Completion (Estimated): December 20, 2023

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: January 23, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Food allergy
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 284/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No