NCT03942692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

May 21, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

October 9, 2019

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

May 7, 2019

Last Update Submit

October 8, 2019

Conditions

Outcome Measures

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

    About 15 minutes

Study Arms (1)

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

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

Children with anaphylactic reaction

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paediatric Emergency Department in Femme-Mère-Enfant Hospital

Bron, 69677, France

Location

MeSH Terms

Conditions

AnaphylaxisHypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 8, 2019

Study Start

May 21, 2019

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

October 9, 2019

Record last verified: 2019-10

Locations