Status:
RECRUITING
Improving Status Epilepticus Treatment Times
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Children's Hospital of Philadelphia
Boston Children's Hospital
Conditions:
Status Epilepticus
Eligibility:
All Genders
30-18 years
Phase:
NA
Brief Summary
This is a stepped-wedge cluster randomized effectiveness-implementation hybrid study aimed at determining the effect of dissemination of a QI bundle on the time to treatment of SE among hospitalized, ...
Detailed Description
The overall study design is a stepped-wedge cluster randomized trial. A stepped-wedge is a unidirectional crossover design in which clusters switch treatments at different time points, enabling statis...
Eligibility Criteria
Inclusion
- SE episode occurs in a male or female child aged between \> 30 days to \< 19 years
- Seizures meeting AT LEAST ONE of the following criteria:
- continuous clinically apparent seizure lasting greater than 5 minutes
- continuous clinically apparent seizure of any duration receiving BZD
- repeated seizures without return to neurological baseline within 5 minutes
Exclusion
- SE episode occurs in a child with infantile spasms
- SE episode occurs in a child with electrographic-only seizures without clinical signs other than encephalopathy
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT06194747
Start Date
February 1 2024
End Date
March 31 2027
Last Update
October 1 2024
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205