The Naples Pediatric Food Allergy (NAPFA) Score

Study Overview
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Brief Summary
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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.

Official Title
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The Naples Pediatric Food Allergy (NAPFA) Score

Conditions
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Food Allergy in Children

Intervention / Treatment
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* Other: Development of the NAPFA score


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subject with suspected food allergy<br> | Other: Development of the NAPFA score<br>* In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food allergy