- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05737056
Rheumatoid Purpura in Children: a Multicenter Observational Study of Pediatric Emergency Department Management and Follow-up by Primary Care Physicians (PREEMS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Colmar, France, 68000
- Hôpitaux civils de Colmar
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Strasbourg, France, 67200
- Hôpital de Hautepierre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Children diagnosed with rheumatoid purpura at the pediatric emergency department
Children diagnosed with rheumatoid purpura from admission to the pediatric emergency department up to two years of follow-up by general practitioners after hospital discharge.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Compliance with the recommendations for the management of rheumatoid purpura
Time Frame: Up to two years after hospital discharge
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Up to two years after hospital discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge assessment questionnaire regarding rheumatoid purpura
Time Frame: At the beginning of the study
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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
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At the beginning of the study
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathologic Processes
- Immune System Diseases
- Hemorrhage
- Skin Manifestations
- Hypersensitivity
- Hematologic Diseases
- Skin Diseases
- Blood Coagulation Disorders
- Skin Diseases, Vascular
- Hemostatic Disorders
- Hemorrhagic Disorders
- Vasculitis
- Purpura
- Immune Complex Diseases
- Pathological Conditions, Signs and Symptoms
- Skin and Connective Tissue Diseases
- Signs and Symptoms
- Hemic and Lymphatic Diseases
- IgA Vasculitis
Other Study ID Numbers
- GHRMSA 1278
- 2022-A02687-36 (Other Identifier: ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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