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The Naples Pediatric Food Allergy (NAPFA) Score (NAPFA)

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ClinicalTrials.gov Identifier: NCT05707858
Recruitment Status : Recruiting
First Posted : February 1, 2023
Last Update Posted : November 18, 2023
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, MD, PhD, Federico II University

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Food Allergy in Children Other: Development of the NAPFA score

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Naples Pediatric Food Allergy (NAPFA) Score
Actual Study Start Date : January 23, 2023
Actual Primary Completion Date : June 22, 2023
Estimated Study Completion Date : December 20, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subject with suspected food allergy 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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   1 Week to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects consecutively observed at the Pediatric Allergy Program, at the Department of Translational Medical Science of the University of Naples Federico II, both sex, aged 0-14 years with suggestive history of food allergy
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05707858


Contacts
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Contact: Roberto Berni Canani, MD 0817462680 berni@unina.it

Locations
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Italy
Department of Traslational Medical Science - University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    0817462680    berni@unina.it   
Sponsors and Collaborators
Federico II University
Investigators
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Principal Investigator: Roberto Berni Canani, MD Department of Translational Medical Science, University of Naples Federico II
More Information
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Responsible Party: Roberto Berni Canani, MD, PhD, Professor of Pediatrics, Federico II University
ClinicalTrials.gov Identifier: NCT05707858    
Other Study ID Numbers: 284/21
First Posted: February 1, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roberto Berni Canani, MD, PhD, Federico II University:
Food allergy
Additional relevant MeSH terms:
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Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate