A Clinical Study of Children With Status Epilepticus in China

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2019-09-30

Brief Summary

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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

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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

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Status Epilepticus

Keywords

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Status Epilepticus Children Multi-center etiology treatment outcome risk factor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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status epileptius

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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

29 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yi Wang

Vice President Chlidren's Hospital of Fudan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yi Wang, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Beijing Children's Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yi Wang, Dr.

Role: CONTACT

Phone: +86-21-64931913

Email: [email protected];[email protected]

Facility Contacts

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Suyun Qian, PhD

Role: primary

Other Identifiers

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2016-165

Identifier Type: -

Identifier Source: org_study_id