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

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.

Study Overview

• Status: Completed
• Conditions: Anaphylaxis; Allergic Reaction
• Intervention / Treatment: Other: Phone call questionnaire

• Study Type: Observational
• Enrollment (Actual): 118

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677
    • Paediatric Emergency Department in Femme-Mère-Enfant Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergy follow-up	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	About 15 minutes

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Actual): August 20, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): October 9, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Shock; Anaphylaxis
• Other Study ID Numbers: 69HCL18_0493

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No