One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish

December 23, 2015 updated by: Stefania La Grutta, MD

In Italy, few data about anaphylaxis due to peanuts in pediatric age are available, conversely data about walnuts/hazelnuts, shellfish/mollusks anaphylaxis have not yet been collected.

Children with physician-confirmed food allergy to peanuts, walnuts/hazelnuts and shellfish/mollusks will be recruited from 9 allergy clinics located in the Italian Territory (Bologna, Lecce, Napoli, Palermo, Parma, Pavia, Roma, Torino, Trento).

Parent of food allergic children will compile a food allergy questionnaire (questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources).

Parent of healthy children will compile a control questionnaire (questions about general information on the family, on life and food habits and on indoor environment) The 1-year survey will determine the frequency of anaphylaxis in allergic outpatient children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

200 Italian children with or without food allergy

Description

Inclusion criteria

  • Cases: 0-14 years old patients with food allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.
  • Controls: 0-14 years old subjects without allergy to peanuts, walnuts/hazelnuts, shellfish/mollusks.

Exclusion criteria

  • Patients/subjects in acute phase of disease or with not controlled chronic pathologies;
  • missing written informed consent by parents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children with food allergy

Children with food allergy to nuts, hazelnuts, walnuts, shellfish and mollusks (1-14 years old).

The Parents of the cases children will compile a Food allergy questionnaire
Other: Food allergy questionnaire
The Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources
Healthy Children
Healthy Children (1-14 years old) The Parents of the control children will compile a Control questionnaire
Other: Control Questionnaire
The Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Anaphylaxis in 1 year
Time Frame: 1 year
To determine the frequency of anaphylaxis in allergic outpatient children
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania La Grutta, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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