A Clinical Study of Children With Status Epilepticus in China

Status Epilepticus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03378687
• Other study ID #: 2016-165
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: December 14, 2017
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: December 2017
• Source: Fudan University
• Contact: Yi Wang, Dr.
• Phone: +86-21-64931913
• Email: yiwang[@]shmu.edu.cn;fdse2016[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Status Epilepticus

Locations

Country	Name	City	State
China	Beijing Children's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The outcome of children with SE at discharge	Use four measures to evaluate the outcome at discharge 1. Normal 2. With dysfunction 3. With secondary epilepsy 4. Death	2016.10.1-2017.6.30
Secondary	Glasgow Outcome Scale(GOS)	The GOS is a prognostic assessment tool for children with SE. GOS Score =1death GOS Score=2 Vegetative state ,Unable to interact with environment; unresponsive; GOS Score=3 Severe disability, Able to follow commands/ unable to live independently ;GOS Score=4 Moderate disability, Able to live independently; unable to return to work or school ;GOS Score=5 Good recovery,Able to return to work or school	2016.10.1-2017.6.30

External Links

•   The Children's Hospital of Fudan University (CHFU) is a service of the National Institute on Children.