Improving Status Epilepticus Treatment Times in Children

This study is looking at ways to improve how quickly children with status epilepticus (SE), which is a long-lasting seizure, receive treatment. Researchers are testing a "quality improvement bundle" that includes using intranasal or buccal midazolam (a type of benzodiazepine, or BZD, medication) as the first treatment, aiming to give this medicine within 10 minutes of the seizure starting, and making sure all necessary supplies are readily available. The study wants to see if these changes can reduce the time it takes to give the first dose of BZD after SE is diagnosed in hospitalized children who are not critically ill. This could help lower the risk of complications and death. Children aged 30 days to 18 years who experience a continuous seizure lasting over 5 minutes, or any continuous seizure for which they receive a BZD, may be able to participate. The current recruitment status is unclear.

Study design
This study is a stepped-wedge cluster randomized trial involving 450 participants across seven centers. All centers will eventually implement the same quality improvement bundle, but at different times.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 30 days, suggesting participants will be followed for at least this long after diagnosis.

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NCT06194747

Improving Status Epilepticus Treatment Times

Recruiting
NAAges 30–18InterventionalTreatment
Nationwide Children's Hospital
~450 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Quality improvement bundleQuality improvement bundle and local PDSA cycles with central supportQuality improvement bundle and local PDSA cycles without central support

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time from the SE diagnosis to first dose of BZD
Measured over 30 days
Status Epilepticus
1 sites across 1 states
Ohio1
  • Adam Ostendorf, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital and The Ohio State University

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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:

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
  • Time from the SE diagnosis to first dose of BZD30 days

    Time in minutes from SE diagnosis to treatment with the first dose of a benzodiazepine (BZD) as measured during hospitalization, which will decrease chances of morbidity and mortality