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Status unknownNCT03378687Updated Dec 20, 2017

A Clinical Study of Children With Status Epilepticus in China

An observational study in Status Epilepticus, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-20.

Sponsored by Fudan University · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,000
Ages
29 Days to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Status Epilepticus

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Keywords

  • Status Epilepticus
  • Children
  • Multi-center
  • etiology
  • treatment
  • outcome
  • risk factor
03

In context

Status Epilepticus

124 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's planned enrollment of 6,000 is above the median of 156 across 42 observational studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

Fudan University is the lead sponsor of 1,315 studies on the registry; 643 are open to participants now.

Browse Fudan University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. A seizure less than 30 minutes
  2. The newborn and more than 18 years old.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2016.10.1-2017.6.30

Secondary outcomes

  1. 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

    Time frame: 2016.10.1-2017.6.30

07

Study locations

1 of 1 sites recruiting
  • Beijing Children's Hospital
    Beijing, Beijing 100045, China
    Recruiting
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2016, a primary completion of Sep 2019 and a completion of Sep 2019. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2017
First posted
Dec 20, 2017
Start
Sep 2016
Primary completionEst.
Sep 2019
CompletionEst.
Sep 2019
Last update
Dec 20, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 20, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03378687
Lead sponsor
Fudan University
Responsible party
Yi Wang (Vice President Chlidren's Hospital of Fudan University, Fudan University) — Principal investigator
First posted
Dec 20, 2017
Start date
Sep 2016
Primary completion
Sep 2019 (estimated)
Completion
Sep 2019 (estimated)
Last update
Dec 20, 2017

Study contacts

Yi Wang, Dr.
Contact
yiwang@shmu.edu.cn;fdse2016@163.com
+86-21-64931913
Yi Wang, PhD,MD
principal investigator · Children's Hospital of Fudan University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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