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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A - 18 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03942692
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospices Civils de Lyon
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Anaphylaxis, Allergic Reaction
Arms & Interventions

Arms

: 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.

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Bron, France

Status

Not yet recruiting

Address

Paediatric Emergency Department in Femme-Mère-Enfant Hospital

Bron, , 69677

Site Contact

Anne-Karine CORREARD, Dr

anne-karine.correard@chu-lyon.fr

04 72 12 94 72 #+33

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