A Clinical Study of Children With Status Epilepticus in China

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

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.

Study Overview

• Status: Unknown
• Conditions: Status Epilepticus

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.

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

• Study Contact: Name: Yi Wang, Dr.; Phone Number: +86-21-64931913; Email: yiwang@shmu.edu.cn;fdse2016@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Recruiting
      • Beijing Children's Hospital
      • Contact: Suyun Qian, PhD; Phone Number: 13370115029; Email: Syqian1211@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 29 days to 18years who were diagnosed with Status epilepticus in 34 hospitals between 1 January 2013 and 31 December 2015.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Yi Wang, PhD,MD, Children's Hospital of Fudan University

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: treatment; Children; outcome; Multi-center; Status Epilepticus; risk factor; etiology
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Seizures; Status Epilepticus
• Other Study ID Numbers: 2016-165