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Prioritizing Hormone Therapy Over Vigabatrin as the First Treatment for Infantile Spasms: A Quality Improvement
John R Mytinger1, William Parker2, Steven W Rust2
1From the Division of Pediatric Neurology (J.R.M., S.M.A., D.V.F.A., C.W.B., A.P.O., J.D.E.T., J.V., A.D.P.), Department of Pediatrics, Nationwide Children's Hospital, and The Ohio State University; The Center for Clinical Excellence (W.P., A.D.P.) ; Information Technology Research & Innovation (S.W.R.), and Division of Pediatric Neurology (J.C., D.J.C., A.D., D.D., M.K., J.H., M.C.T.), Department of Pediatrics, Nationwide Children's Hospital, Columbus, OH. john.mytinger@nationwidechildrens.org.
Insights
Quality improvement initiatives standardizing hormone therapy for infantile spasms (IS) significantly increased 3-month electroclinical remission rates. This approach improved treatment timelines and outcomes for children with IS.
Area of Science:
- Pediatric Neurology
- Clinical Quality Improvement
- Epileptology
Background:
- Infantile spasms (IS) are severe early childhood seizures with significant long-term consequences.
- Standard therapies include adrenocorticotropic hormone (ACTH), high-dose prednisolone, and vigabatrin, with hormone therapy often showing higher initial remission rates.
- Nontuberous sclerosis complex (TSC)-associated IS requires effective early treatment strategies.
Purpose of the Study:
- To increase the percentage of children with new-onset nontuberous sclerosis complex (TSC)-associated IS achieving 3-month electroclinical remission from 53.8% to ≥70%.
- To implement quality improvement (QI) methodology prioritizing hormone therapy as the first treatment for IS.
- To reduce delays in initiating appropriate treatment and subsequent therapies for non-responders.
Main Methods:
- An observational, consecutive sample cohort study comparing a prospective intervention cohort (N=57) with a retrospective baseline cohort (N=67).
- The QI initiative standardized hormone therapy (ACTH or high-dose prednisolone) as the first treatment, addressing vigabatrin's prior routine use.
- Key process measures included the rate of first-line hormone therapy use and time to follow-up and second-line treatment initiation.
Main Results:
- QI interventions led to a significant increase in 3-month electroclinical remission rates, from 53.8% in the baseline cohort to 75.9% in the intervention cohort.
- The rate of children receiving hormone therapy as first treatment increased from a mean of 44.6% to 100%.
- Time to clinical follow-up decreased from 16.3 to 12.6 days, and the proportion of patients starting a second treatment within 14 days for initial non-responders decreased from 36.3% to 17.2 days.
Conclusions:
- Quality improvement methodology can significantly enhance electroclinical remission rates in children with infantile spasms.
- Standardizing hormone therapy as the initial treatment is an effective strategy for improving IS outcomes.
- The successful implementation of this QI initiative suggests its potential for replication at other centers to improve IS management.
Background And Objectives:
Infantile spasms (IS) are early childhood seizures with potentially devastating consequences. Standard therapies (adrenocorticotropic hormone [ACTH], high-dose prednisolone, and vigabatrin) are strongly recommended as the first treatment for IS. Although this recommendation comes without preference for one standard therapy over another, early remission rates are higher with hormone therapy (ACTH and high-dose prednisolone) when compared with vigabatrin. Using quality improvement (QI) methodology that included hormone therapy as the first treatment, we sought to increase the percentage of children with new-onset nontuberous sclerosis complex (TSC)-associated IS achieving 3-month electroclinical remission from a mean of 53.8% to ≥70%.
Methods:
This was an observational consecutive sample cohort study at a single academic tertiary care hospital that compared a prospective intervention cohort (May 2019-January 2022, N = 57) with a retrospective baseline cohort (November 2015-April 2019, N = 67). Our initiative addressed key drivers such as the routine use of vigabatrin over hormone therapy as first treatment and the common initiation of a second treatment after 14 days for initial nonresponders. We included consecutive children without TSC presenting with new-onset IS diagnosed and treated between ages 2 and 24 months. We displayed our primary outcome and process measures as control charts in which the centerline is the quarterly (previous 3 months) mean based on statistical process control methodology.
Results:
QI interventions that included the standardization of hormone therapy as the first treatment resulted in higher rates of 3-month remission, rising from 53.8% (baseline cohort) to 75.9% (intervention cohort). Process measure results included an increased rate of children receiving hormone therapy as first treatment (mean, 44.6%-100%) and a decreased number of days to both clinical follow-up after first treatment (mean, of 16.3-12.6 days) and starting a second treatment within 14 days for initial nonresponders (mean, 36.3-17.2 days).
Discussion:
For children with IS, improved rates of 3-month electroclinical remission can be achieved with QI methodology. Implementation of similar QI initiatives at other centers may likewise improve local remission rates.
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