Recruiting

Benzodiazepine

Sponsor:

Nationwide Children's Hospital

Code:

NCT06194747

Conditions

Status Epilepticus

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Quality improvement bundle

Quality improvement bundle and local PDSA cycles with central support

Quality improvement bundle and local PDSA cycles without central support

Study Details

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.

Conditions

Status Epilepticus

Study ID

NCT06194747

Start date

Feb 1, 2024

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Baseline phase

During this arm, sites will provide routine care.

experimental: Adoption phase

Following the dissemination visit, sites will actively work to implement the bundle of interventions.

experimental: Sustain phase

During this arm, sites will actively work to sustain the implemented interventions and will be allowed to develop site-specific plan-do-study-act cycles in order to address site-specific key drivers with central data and methodological support.

experimental: Independent phase

During this arm, sites will continue to sustain the implemented interventions and develop site-specific plan-do-study-act cycles in order to address site-specific key drivers without central data and methodological support.

Interventions

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

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.

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 measure

  • Time from the SE diagnosis to first dose of BZD [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Adam Ostendorf, MD

614-722-5145adam.ostendorf@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Adam P Ostendorf, MD

614-722-5145adam.ostendorf@nationwidechildrens.org

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Apr 1, 2026

Last verified

Mar, 2026

Keywords

  • Status Epilepticus
  • Quality Improvement
  • Interventions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-04-01.