Neuropsycatric Disorders Among Children With Systemic Lupus Erythematosus in Sohag University Hospital

June 7, 2024 updated by: Amira Mahmoud Ahmed, Sohag University
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease involving multiple organs, characterized by the production of autoantibodies and the development of tissue injury. The etiology of SLE is partially known, involving multiple genetic and environmental factors. As many as 50% of patients with SLE have neurological involvement during the course of their disease. Approximately 40% of neuropsychiatric SLE (NPSLE) cases are a consequence of the disease itself; other causes of NPSLE are infections, metabolic disorders, and side effects of drugs. The American College of Rheumatology identified 19 neuropsychiatric syndromes in SLE patients that can be divided into central and peripheral nervous system manifestations. Although this classification includes syndromes with no clear pathophysiological mechanism and is not specific for neuropsychiatric events caused exclusively by SLE, it helps the physician to recognize any neurological involvement . The most common clinical manifestations of juvenile neuropsychiatric SLE (NPSLE) are headache, cognitive dysfunction, mood disturbances and seizures. The pathophysiology of juvenile NPSLE is not yet fully known, but immunological and inflammatory factors, such as autoantibodies, cytokine and prothrombotic states are widely described . The of autoantibodies in the onset of specific clinical manifestations has also been recognized. Juvenile NPSLE manifestations are often difficult to diagnose (. Nineteen neuropsychiatric syndromes have been identified associated with SLE, can be divided into central and peripheral manifestations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Montaser M Mohammed, assistant professor
  • Phone Number: 01026372799

Study Contact Backup

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

The study aims to include all children fulfilling the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology (9)) attending to pediatric rheumatology and immunology clinic at Sohag University Hospitals during the study period

Description

Inclusion Criteria:

  • The study aims to include all children fulfilling the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology (9)) attending to pediatric rheumatology and immunology clinic at Sohag University Hospitals during the study period.

Exclusion Criteria:

  • Children with other rheumatological disorders.; Neonates (infants > 1 month) Children with other neuropsychiatric disorders not attributed to SLE ( e.g. infection, metabolic disorders or side effects of drugs).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detect the clinical spectrum of Neuropsycatric disorders in Children with SLE
Time Frame: 1 year
the diagnostic criteria of SLE (The European League Against Rheumatism and The American College of Rheumatology
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 7, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-05-10MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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