A Clinical Study of Children With Status Epilepticus in China

Fudan University

Status: Unknown

Conditions: Status Epilepticus

Study type: Observational

Funder types: Other

Identifiers

NCT03378687

2016-165

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 29 days to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who meet the diagnosis of Status Epilepticus(SE),which is defined as more than 30 minutes of either1).continuous seizure activity or 2).two or more sequential seizures without full recovery of consciousness between seizures, including Status Epilepticus (CSE) and Nonconvulsive Status Epilepticus(NCSE).
2. The age range: 29 days to <18years
3. Cases with complete clinical information.
4. Inpatient. All cases those meet full of the above 4 criterias are included in our study.

Exclusion criteria

1. A seizure less than 30 minutes
2. The newborn and more than 18 years old.

Trial design

6,000 participants in 1 patient group

status epileptius

Description:

Cases were patients 29 days to 18 years who were diagnosed with status epileptius in 35 hospitals in China between January 1， 2013 and December 31，2015.