A Clinical Study of Children With Status Epilepticus in China

NCT03378687 | Unknown DMC

• 1 other identifier: 2016-165
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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. 1.to obtain national epidemiological data on the etiology, diagnosis,treatment,evaluation, risk factors , outcome and analyze the burden of disease.
2. 2.to build a Collaborative Network in pediatric status epilepticus research.
3. 3.to establish a national clinical database of pediatric status epilepticus.
4. 4.to lay the foundation for the further prospective study.

Conditions

Status Epilepticus

Keywords

Status Epilepticus; Children; Multi-center; etiology; treatment; outcome; risk factor

Outcome Measures

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

  2016.10.1-2017.6.30

Secondary Outcomes (1)

• Glasgow Outcome Scale(GOS)

  2016.10.1-2017.6.30

Study Arms (1)

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.

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

RECRUITING

Related Links

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

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yi Wang, PhD,MD

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Wang, Dr.

CONTACT

+86-21-64931913; yiwang@shmu.edu.cn;fdse2016@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President Chlidren's Hospital of Fudan University

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: December 20, 2017
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

CN (1)