A Clinical Study of Children With Status Epilepticus in C... | NCT03378687

Studies
A Clinical Study of Children With Status Epilepticus in China

NCT03378687

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Dec 20, 2017Actual

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Status Epilepticus

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Sep 2019Estimated

Completion Date

Sep 2019Estimated

First Submitted Date

May 15, 2017

First Submission Date that Met QC Criteria

Dec 14, 2017

First Posted Date

Dec 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 14, 2017

Last Update Posted Date

Dec 20, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yi Wang, Vice President Chlidren's Hospital of Fudan University, Fudan UniversityPrincipal Investigator

Lead Sponsor

Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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:

to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation, risk factors , outcome and analyze the burden of disease.
to build a Collaborative Network in pediatric status epilepticus research.
to establish a national clinical database of pediatric status epilepticus.
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:

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.
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.
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.
The standardized management of the database and quality control:There is a special person administrating the database and controlling the quality of data.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
The age range: 29 days to <18years
Cases with complete clinical information.
Inpatient. All cases those meet full of the above 4 criterias are included in our study.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

29 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yi Wang, Dr.	Contact	+86-21-64931913		yiwang@shmu.edu.cn;fdse2016@163.com

Overall Officials

Name	Affiliation	Role
Yi Wang, PhD,MD	Children's Hospital of Fudan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Children's Hospital	Recruiting	Beijing	Beijing Municipality	100045	China

References Module

Citations

Not provided

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms