Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians

Rheumatoid Purpura Clinical Trial

— PREEMS  

Official title:

Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05737056
• Other study ID #: GHRMSA 1278
• Secondary ID: 2022-A02687-36
• Status: Completed
• Start date: May 9, 2023
• Est. completion date: July 28, 2023

Study information

• Verified date: October 2023
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this study is to describe the management of children with rheumatoid purpura from admission to the pediatric emergency room to follow-up by primary care physicians after hospital discharge.

Description:

Secondary objectives The secondary objective is to assess general practitioners current knowledge and practice of the condition and potential barriers to monitoring and follow-up by general practitioners.

Conduct of research Children diagnosed with rheumatoid purpura within the past 2 years at the 3 participating sites will be included in the study if parental authority holders do not object.

Patients will be identified through the Medical Information Department of each hospital.

Parents will be contacted - first by mail, then by phone - to request permission to collect the child's medical data from medical records, and to retrieve information on the surveillance and follow-up of the disease by general practitioners up to two years after diagnosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

Inclusion Criteria:

• Underaged patient diagnosed with rheumatoid purpura during a visit to the pediatric emergencies of Mulhouse, Colmar and Strasbourg

• No objection to the study from the two holders of parental authority

Exclusion Criteria:

• Patient followed in the context of a genetic or malformative pathology, an immune deficiency, or a cancer

Related Conditions & MeSH terms

• Emergencies
• IgA Vasculitis
• Purpura
• Rheumatoid Purpura

Intervention

Other:
• Management of rheumatoid purpura
Collection of data on the management in pediatric emergency departments (method of diagnosis, complementary examinations, proposed treatment, number of hospitalizations, follow-up after hospital discharge).

Locations

Country	Name	City	State
France	Hôpitaux Civils de Colmar	Colmar
France	Hôpital de Hautepierre	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance with the recommendations for the management of rheumatoid purpura		Up to two years after hospital discharge
Secondary	Knowledge assessment questionnaire regarding rheumatoid purpura	Evaluation of the knowledge and current practices of general practitioners regarding rheumatoid purpura and identification of the possible obstacles to management and follow-up in primary care, using an online survey	At the beginning of the study