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

NCT02640560 | Completed

• 1 other identifier: 10/2012
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Food Allergy

Keywords

Children; Allergy; Peanuts; Hazelnuts; Walnuts; Mollusks; Shellfish; Food

Outcome Measures

Primary Outcomes (1)

• Frequency of Anaphylaxis in 1 year

  To determine the frequency of anaphylaxis in allergic outpatient children

  1 year

Study Arms (2)

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

Healthy Children

Healthy Children (1-14 years old) The Parents of the control children will compile a Control questionnaire

Other: Control Questionnaire

Interventions

Food allergy questionnaire OTHER

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

Children with food allergy

Control Questionnaire OTHER

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.

Healthy Children

Eligibility Criteria

• Age: 1 Year - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

200 Italian children with or without food allergy

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stefania La Grutta, MD: lead

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Stefania La Grutta, MD. Senior Researcher. Coordinator of Pediatric Allergy and Asthma Research Group. Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 29, 2015
• Study Start: October 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 29, 2015

Record last verified: 2015-12