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

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ClinicalTrials.gov Identifier: NCT02640560
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : December 29, 2015
Sponsor:
Information provided by (Responsible Party):
Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica

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.


Condition or disease Intervention/treatment
Food Allergy Other: Food allergy questionnaire Other: Control Questionnaire

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish
Study Start Date : October 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Frequency of Anaphylaxis in 1 year [ Time Frame: 1 year ]
    To determine the frequency of anaphylaxis in allergic outpatient children



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 Italian children with or without food allergy
Criteria

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

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Responsible Party: Stefania La Grutta, MD, 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., Istituto per la Ricerca e l'Innovazione Biomedica
ClinicalTrials.gov Identifier: NCT02640560     History of Changes
Other Study ID Numbers: 10/2012
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015

Keywords provided by Stefania La Grutta, MD, Istituto per la Ricerca e l'Innovazione Biomedica:
Children
Allergy
Peanuts
Hazelnuts
Walnuts
Mollusks
Shellfish
Food

Additional relevant MeSH terms:
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Food Hypersensitivity
Anaphylaxis
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases