The Naples Pediatric Food Allergy (NAPFA) Score

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.

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Key information

Conditions

Food Allergy in Children Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

1 week–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Traslational Medical Science - University of Naples Federico II

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

Time frame: at the enrollment

The score will include the main anamnestic and clinical features

Secondary outcomes

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

Time frame: 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

Time frame: at the enrollment

Validation of the score on pediatric subject with suspected FA

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Acronym: NAPFA

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 1, 2023
Registry last updated: May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed