The Naples Pediatric Food Allergy (NAPFA) Score

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05707858

Acronym

NAPFA

Enrollment

600

Registered

2023-02-01

Start date

2023-01-23

Completion date

2023-12-20

Last updated

2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy in Children

Keywords

Food allergy

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.

Interventions

OTHERDevelopment of the NAPFA score

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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 14 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026