Food Allergy in ChildrenNAPFANCT05707858
The Naples Pediatric Food Allergy (NAPFA) Score
An observational study of Food Allergy in Children, run by Federico II University at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 week to 14 years
- Conditions the study is for
- Food Allergy in Children
- What is being tested?
- Development of the NAPFA score
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 23 Jan 2023to 20 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 14 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- subjects aged between 0-14 years with suggestive history of food allergy
Who cannot join
- chronic systemic diseases,
- malignancy,
- immunodeficiency,
- infectious diseases,
- autoimmune diseases,
- inflammatory bowel diseases,
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- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Traslational Medical Science - University of Naples Federico II
Naples, 80131
About this study
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.
- Conditions
- Food Allergy in Children
- Being tested
- Development of the NAPFA score
- Keywords
- Food allergy
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Development of the NAPFA scoreOther
In subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score
| Study group | Role | What they receive |
|---|---|---|
| Subject with suspected food allergy | Not described Receives: Other: Development of the NAPFA score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at the enrollment
Secondary outcomes (2)
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
Measured: at the enrollment
Validation of the new clinical NAPFA score for the identification of pediatric FA
Validation of the score on pediatric subject with suspected FA
Measured: at the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start23 Jan 2023
- Primary completion22 Jun 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in ChildrenStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
- Investigators
- Roberto Berni Canani, MD, Principal investigator, Department of Translational Medical Science, University of Naples Federico II
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05707858
- Sponsor's protocol ID
- 284/21
- Acronym
- NAPFA
- Status last verified
- May 2025
- First submitted
- 23 Jan 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Naples Pediatric Food Allergy (NAPFA) Score
- ClinicalTrials.gov ID
- NCT05707858
- Acronym / sponsor ID
- NAPFA / 284/21
- Conditions
- Food Allergy in Children
- Keywords
- Food allergy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject with suspected food allergy | – | Other: Development of the NAPFA score |
Who may qualify
- Ages
- 1 week to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- subjects aged between 0-14 years with suggestive history of food allergy
Key exclusion criteria (15 listed)
- chronic systemic diseases,
- malignancy,
- immunodeficiency,
- infectious diseases,
- autoimmune diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of the NAPFA scoreIn subjects with suspected food allergy we will evaluate main anamnestic, and clinical features to develop the NAPFA score | Other | Subject with suspected food allergy |
Primary outcome
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
2 secondary outcomes
Development of a new clinical score for the identification of pediatric FA in secondary and tertiary care setting
Time frame: at the enrollment
Validation of the new clinical NAPFA score for the identification of pediatric FA
Time frame: at the enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roberto Berni Canani, MD principal investigator
Department of Translational Medical Science, University of Naples Federico II
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Children, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a new clinical score for the identification of pediatric FA in primary care setting (time frame: at the enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.