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NCT05707858
The Naples Pediatric Food Allergy (NAPFA) Score
Conditions: Food Allergy in Children
Sex: All
Ages: 1 Week – 14 Years
Enrollment: 600
Sponsor: Federico II University
Location: Italy
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.
Eligibility Criteria
Inclusion Criteria:subjects aged between 0-14 years with suggestive history of food allergyExclusion Criteria:Exclusion criteria: age >14 yearschronic 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 monthsuse of steroids and antihistamines in the previous 2 weeks
Source: ClinicalTrials.gov (NCT05707858). StuddyBuddy aggregates publicly available trial information.