The Naples Pediatric Food Allergy (NAPFA) Score

Food Allergy in Children Clinical Trial

— NAPFA  

Official title:

The Naples Pediatric Food Allergy (NAPFA) Score

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05707858
• Other study ID #: 284/21
• Status: Recruiting
• Start date: January 23, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: November 2023
• Source: Federico II University
• Contact: Roberto Berni Canani, MD
• Phone: 0817462680
• Email: berni[@]unina.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 20, 2023
• Est. primary completion date: June 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Week to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy in Children
• Food Hypersensitivity
• Hypersensitivity

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Traslational Medical Science - University of Naples Federico II	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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