NCT03378687

A Clinical Study of Children With Status Epilepticus in China

A Multi-center Clinical Study of Children With Status Epilepticus in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 6,000 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 29 Days – 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1: The first part of study is a multi-center, retrospect study involving 38 hospitals. The program is a national epidemiological study on status epilepticus in Chinese children.The aims of the epidemiological study include: 1. to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation, risk factors , outcome and analyze the burden of disease. 2. to build a Collaborative Network in pediatric status epilepticus research. 3. to establish a national clinical database of pediatric status epilepticus. 4. to lay the foundation for the further prospective study. Phase 2: The second part of study is a multi-center, prospective study involving 38 hospitals. The aim of the study is to set up guideline of Children with SE in China.

Detailed description

Methods: 1. Case retrieval: The investigators query cases with a diagnostic code of SE via usage of the International Classification of Diseases, 10th revision (ICD-10) code G41. 2. Data collection:The subjects will be recruited from all hospitals.The investigators collect detailed information by a standardized questionnaire ,which contains each patient's age, gender, the date of occurrence of SE, past history of SE and seizures, etiology of SE, developmental history, underlying diseases, family history of seizures, duration of SE, seizure types of SE, laboratory data,EEG findings during SE and/or after SE, cranial CT and/or MRI findings after SE, medical treatment during the acute period and the outcome.The outcome include neurological sequelae, recurrence and death following SE. 3. The establishment of the database and data entry :The investigators established a database according the standardized questionnaire. Then the information will be put in the database by the responsible person of each hospital. 4. The standardized management of the database and quality control:There is a special person administrating the database and controlling the quality of data.

Conditions

• Status Epilepticus

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-12-20
• Last updated: 2017-12-20

Locations

1 site across 1 country: China