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Recruiting NCT06194747

Improving Status Epilepticus Treatment Times

Trial Parameters

Condition Status Epilepticus
Sponsor Nationwide Children's Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 450
Sex ALL
Min Age 30 Days
Max Age 18 Years
Start Date 2024-02-01
Completion 2027-03-31
Interventions
Quality improvement bundleQuality improvement bundle and local PDSA cycles with central supportQuality improvement bundle and local PDSA cycles without central support

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, non-critically ill children. The primary study endpoint is to decrease the time from the SE diagnosis to treatment with the first dose of a benzodiazepine (BZD) as measured during hospitalization, which will decrease chances of morbidity and mortality.

Eligibility Criteria

Inclusion Criteria: * 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: 1. continuous clinically apparent seizure lasting greater than 5 minutes 2. continuous clinically apparent seizure of any duration receiving BZD 3. repeated seizures without return to neurological baseline within 5 minutes Exclusion Criteria: * 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

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