NCT06194747 · Nationwide Children's Hospital
Improving Status Epilepticus Treatment Times
(QuITT-SE)
What this study is about
This is a stepped-wedge cluster randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
Quality improvement bundle
(1) standardizing BZD default to intranasal or buccal midazolam; (2) targeting initial BZD treatment within 10 minutes of seizure onset; (3) relocating and bundling all administration items needed to the hospital unit medication room; (4) utilizing basic seizure first aid in the initial patient assessment; (5) developing and implementing SE-specific EHR documentation; (6) multidisciplinary QI teams
OTHER
Quality improvement bundle and local PDSA cycles with central support
Sites will implement both the standard QI bundle as well as site-specific PDSA cycles with central data and methods support.
OTHER
Quality improvement bundle and local PDSA cycles without central support
Sites will implement both the standard QI bundle as well as site-specific PDSA cycles without central data or methods support.
Primary outcome measures
Time from the SE diagnosis to first dose of BZD
Time frame: 30 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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 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
- Columbus, Ohio
Collaborators
Children's Hospital of Philadelphia, Boston Children's Hospital, Children's National Research Institute, Children's Hospital and Health System Foundation, Wisconsin, UVA Children's Hospital, Seattle Children's Hospital, Phoenix Children's Hospital, Emory University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 1, 2026 · Source of record for eligibility and locations