A Clinical Study of Children With Status Epilepticus in China

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03378687
Collaborator
(none)
6,000
1
36
166.8

Study Details

Study Description

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:

  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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    6000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    A Multi-center Clinical Study of Children With Status Epilepticus in China
    Study Start Date :
    Sep 1, 2016
    Anticipated Primary Completion Date :
    Sep 1, 2019
    Anticipated Study Completion Date :
    Sep 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. The outcome of children with SE at discharge [2016.10.1-2017.6.30]

      Use four measures to evaluate the outcome at discharge 1. Normal 2. With dysfunction 3. With secondary epilepsy 4. Death

    Secondary Outcome Measures

    1. Glasgow Outcome Scale(GOS) [2016.10.1-2017.6.30]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    29 Days to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beijing Children's Hospital Beijing Beijing China 100045

    Sponsors and Collaborators

    • Fudan University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Yi Wang, Vice President Chlidren's Hospital of Fudan University, Fudan University
    ClinicalTrials.gov Identifier:
    NCT03378687
    Other Study ID Numbers:
    • 2016-165
    First Posted:
    Dec 20, 2017
    Last Update Posted:
    Dec 20, 2017
    Last Verified:
    Dec 1, 2017
    Keywords provided by Yi Wang, Vice President Chlidren's Hospital of Fudan University, Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 20, 2017