Improving Status Epilepticus Treatment Times
ConditionStatus Epilepticus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-18
SponsorNationwide Children's Hospital
About this trial
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
Qualifiers
SE episode occurs in a male or female child aged between > 30 days to < 19 years
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Quality improvement bundle
- Quality improvement bundle and local PDSA cycles with central support
- Quality improvement bundle and local PDSA cycles without central support
Treatment groups
450 Participants
are divided into 4 treatment groupsSponsors and collaborators
Nationwide Children's Hospital
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Boston Children's Hospital
Collaborator
Children's National Research Institute
Collaborator
Children's Hospital and Health System Foundation, Wisconsin
Collaborator
UVA Children's Hospital
Collaborator
Seattle Children's Hospital
Collaborator
Phoenix Children's Hospital
Collaborator
Emory University
Collaborator
Source ClinicalTrials.gov