Improving treatment times for children with status epilepticus
Official title: Quality Improvement in Time to Treatment of Status Epilepticus
Run by Nationwide Children's Hospital · NCT06194747 · Data updated 2026-11-12
This study is testing a new way to speed up treatment for children with status epilepticus in hospitals to see if it helps them get their first dose of medicine faster.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Days to 18 Years |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Nationwide Children's Hospital Academic / other |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT06194747 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged over 30 days to under 19 years who are experiencing an episode of status epilepticus.
✕Probably not a fit
Patients with infantile spasms or those experiencing electrographic-only seizures without clinical signs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance the treatment times for status epilepticus in hospitalized children by implementing a quality improvement (QI) bundle across seven medical centers. Utilizing a stepped-wedge cluster randomized design, the study will assess the impact of this QI bundle on the time taken to administer the first dose of benzodiazepine after diagnosis. The approach includes both effectiveness and implementation components, focusing on evidence-based, low-risk interventions that can be easily integrated into clinical practice. By analyzing barriers and facilitators to implementation, the study seeks to provide valuable insights for broader application of the QI strategies post-trial.
Why it matters
Potential benefit: If successful, this study could significantly reduce the time to treatment for children experiencing status epilepticus, potentially decreasing morbidity and mortality associated with this condition.
How similar studies have gone: Other studies utilizing quality improvement interventions in emergency settings have shown promise, suggesting that this approach may be effective in improving treatment times for status epilepticus.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Nationwide Children's Hospital
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Adam Ostendorf, MD — Nationwide Children's Hospital and The Ohio State University
- Study coordinator: Adam Ostendorf, MD
- Email: adam.ostendorf@nationwidechildrens.org
- Phone: 614-722-5145
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.