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What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction (SAPRA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03942692
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

Anaphylaxis is an allergic reaction potentially fatal. The treatment is based on injection of epinephrin as soon as possible. Guidelines by the World Allergic Organisation highlight the importance of medical follow-up. This follow-up consists of an allergy consultation, the prescription and demonstration of epinephrin auto-injector and the implementation of specific measures in schools. There is no study about the recurrence of anaphylactic reaction outside the hospital.

The purpose of this study is to evaluate the allergy follow-up of children after anaphylactic reaction. The secondary objective is to evaluate the use of medical advice in case of recurrence of anaphylactic reaction.

Investigators will use a phone call questionnaire for parents of children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in the Paediatric Emergency Department in Femme-Mère-Enfant Hospital in Lyon in France. 179 children could be included in the study.


Condition or disease Intervention/treatment
Anaphylaxis Allergic Reaction Other: Phone call questionnaire

Study Design
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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: What is the Allergy Follow-up for Children After Anaphylactic Reaction? AFCAR : Allergy Follow-up for Children After Anaphylactic Reaction
Actual Study Start Date : May 21, 2019
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anaphylaxis

Groups and Cohorts
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Group/Cohort Intervention/treatment
Children with anaphylactic reaction
Children who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.
 Other: Phone call questionnaire

Questionnaire for parents of subject about :

  • the frequency of consultations with an allergist
  • the information of the general practitioner or pediatrician
  • the prescription of epinephrin auto-injector
  • the frequency of renewal of epinephrin auto-injector
  • the specialty of doctor who prescribed the renewal
  • the implementation of specific measures in schools
  • the frequency of renewal of specific measures in schools
  • the number of recurrence of anaphylactic reaction
  • the use of medical advice in case of recurrence of anaphylactic reaction


Outcome Measures
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Primary Outcome Measures :
  1. Allergy follow-up [ Time Frame: About 15 minutes ]

    Allergy follow-up evaluation with :

    • the frequency of consultations with an allergist
    • the information of the general practitioner or pediatrician
    • the prescription of epinephrin auto-injector
    • the frequency of renewal of epinephrin auto-injector
    • the specialty of doctor who prescribed the renewal
    • the implementation of specific measures in schools
    • the frequency of renewal of specific measures in schools
    • the number of recurrence of anaphylactic reaction
    • the use of medical advice in case of recurrence of anaphylactic reaction


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children from 0 to 18 year old who underwent an anaphylactic reaction between the 1st July 2014 and the 31st June 2016 treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France.
Criteria

Inclusion Criteria:

  • Age from 0 to 17
  • Anaphylactic reaction meeting the criteria of Sampson et al. treated in Paediatric Emergency Department of Femme-Mère-Enfant Hospital in Lyon in France
  • Anaphylactic reaction treated between the 1st July 2014 and the 31st June 2016

Exclusion Criteria:

- No agreement from patient or parents to participate in the study

Contacts and Locations
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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): NCT03942692


Locations
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France
Paediatric Emergency Department in Femme-Mère-Enfant Hospital
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03942692    
Other Study ID Numbers: 69HCL18_0493
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Anaphylaxis
Shock
 Immune System Diseases
Hypersensitivity, Immediate
Pathologic Processes