NCT06194747 Improving Status Epilepticus Treatment Times
| NCT ID | NCT06194747 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nationwide Children's Hospital |
| Condition | Status Epilepticus |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 450 participants in total. It began in 2024-02-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Adam Ostendorf, MD
PRINCIPAL INVESTIGATOR
Nationwide Children's Hospital and The Ohio State University
Frequently Asked Questions
Who can join the NCT06194747 clinical trial?
This trial is open to participants of all sexes, aged 30 Days or older, up to 18 Years, studying Status Epilepticus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06194747 currently recruiting?
Yes, NCT06194747 is actively recruiting participants. Contact the research team at adam.ostendorf@nationwidechildrens.org for enrollment information.
Where is the NCT06194747 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06194747 clinical trial?
NCT06194747 is sponsored by Nationwide Children's Hospital. The principal investigator is Adam Ostendorf, MD at Nationwide Children's Hospital and The Ohio State University. The trial plans to enroll 450 participants.