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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03942692
Other study ID # 69HCL18_0493
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2019
Est. completion date August 20, 2019

Study information

Verified date October 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date August 20, 2019
Est. primary completion date August 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Paediatric Emergency Department in Femme-Mère-Enfant Hospital Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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