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CompletedNCT03942692SAPRAUpdated Oct 9, 2019

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

An observational study in Anaphylaxis and Allergic Reaction, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
118
Ages
Up to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anaphylaxis
  • Allergic Reaction
03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 118 is close to the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • No agreement from patient or parents to participate in the study
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
118 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherPhone 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: About 15 minutes

07

Study locations

1 site
  • Paediatric Emergency Department in Femme-Mère-Enfant Hospital
    Bron, 69677, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03942692
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
May 8, 2019
Start date
May 21, 2019
Primary completion
Aug 20, 2019
Completion
Aug 20, 2019
Last update
Oct 9, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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