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Association of Time to Clinical Remission With Sustained Resolution in Children With New-Onset Infantile Spasms
Christopher J Yuskaitis1, John R Mytinger2, Fiona M Baumer2
1From the Division of Epilepsy and Clinical Neurophysiology (C.J.Y., C.H.), Department of Neurology, Boston Children's Hospital, MA; Department of Pediatrics (J.R.M.), Division of Pediatric Neurology, Nationwide Children's Hospital, The Ohio State University, Columbus; Division of Child Neurology (F.M.B.), Department of Neurology, Stanford University School of Medicine, Palo Alto, CA; Department of Neurology and ICCTR Biostatistics and Research Design Center (B.Z., S.L.), Boston Children's Hospital and Harvard Medical School, MA; Division of Child Neurology (D.S.), Department of Pediatrics, University of Arkansas for Medical Sciences, AR; Department of Pediatrics (S.A.H.), Division of Neurology, University of California, Los Angeles; Department of Neurology (E.G.Y.), Montefiore Medical Center, Bronx, NY; Jane and John Justin Neurosciences (C.G.K.), Cook Children's Hospital, Fort Worth, TX; Departments of Pediatrics and Neurology (C.J.), University of Colorado School of Medicine and Children's Hospital Colorado, Aurora; Department of Pediatrics (R.K.S.), Division of Neurology, Atrium Health/Levine Children's, Charlotte, NC; Division of Pediatric Neurology (S. Bhatia), Department of Pediatrics, Medical University of South Carolina, Charleston; Department of Pediatrics (S. Bhalla), Division of Child Neurology, Emory University School of Medicine, Children's Healthcare of Atlanta, GA; and Department of Pediatrics (R.S.), Michigan Medicine, University of Michigan, Ann Arbor, MI. christopher.yuskaitis@childrens.harvard.edu.
Insights
Early identification of infantile spasms treatment response is crucial. Most infants respond within a week, and non-responders may need immediate reassessment for sequential therapy to optimize outcomes.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Trials
Background:
- Standard infantile spasms treatments like ACTH, oral steroids, or vigabatrin are ineffective for nearly half of affected children.
- Early identification of non-responders is critical for timely initiation of sequential therapies.
- Infantile spasms require prompt and effective treatment to improve long-term outcomes.
Purpose of the Study:
- To determine the time to clinical remission in infants with infantile spasms following standard treatment initiation.
- To identify predictors of treatment response time in infantile spasms.
- To inform clinical practice regarding the timing of reassessment for non-responding infants.
Main Methods:
- Prospective cohort study of 395 children aged 2-24 months with new-onset infantile spasms.
- Inclusion of children treated with standard therapies: ACTH, oral steroids, or vigabatrin.
- Definition of sustained treatment response based on spasm cessation, EEG normalization, and persistent remission.
Main Results:
- Clinical remission occurred within 2 weeks in 43% of infants, with 81% of those responding within the first week.
- No significant difference in median time to response was observed among ACTH, oral steroids, or vigabatrin.
- Absence of hypsarrhythmia on pretreatment EEG predicted a higher likelihood of early treatment response (HR 2.23).
Conclusions:
- Clinical remission for infantile spasms can often be identified by day 7 of treatment.
- Infants not responding to initial standard therapy within one week warrant immediate reassessment.
- Facilitating early sequential therapy for non-responders can optimize treatment outcomes in infantile spasms.
Background And Objectives:
Standard therapies (adrenocorticotropic hormone [ACTH], oral steroids, or vigabatrin) fail to control infantile spasms in almost half of children. Early identification of nonresponders could enable rapid initiation of sequential therapy. We aimed to determine the time to clinical remission after appropriate infantile spasms treatment initiation and identify predictors of the time to infantile spasms treatment response.
Methods:
The National Infantile Spasms Consortium prospectively followed children aged 2-24 months with new-onset infantile spasms at 23 US centers (2012-2018). We included children treated with standard therapy (ACTH, oral steroids, or vigabatrin). Sustained treatment response was defined as having the last clinically recognized infantile spasms on or before treatment day 14, absence of hypsarrhythmia on EEG 2-4 weeks after treatment, and persistence of remission to day 30. We analyzed the time to treatment response and assessed clinical characteristics to predict sustained treatment response.
Results:
Among 395 infants, clinical infantile spasms remission occurred in 43% (n = 171) within the first 2 weeks of treatment, of which 81% (138/171) responded within the first week of treatment. There was no difference in the median time to response across standard therapies (ACTH: median 4 days, interquartile range [IQR] 3-7; oral steroids: median 3 days, IQR 2-5; vigabatrin: median 3 days, IQR 1-6). Individuals without hypsarrhythmia on the pretreatment EEG (i.e., abnormal but not hypsarrhythmia) were more likely to have early treatment response than infants with hypsarrhythmia at infantile spasms onset (hazard ratio 2.23, 95% CI 1.39-3.57). No other clinical factors predicted early responders to therapy.
Discussion:
Remission after first infantile spasms treatment can be identified by treatment day 7 in most children. Given the importance of early and effective treatment, these data suggest that children who do not respond to standard infantile spasms therapy within 1 week should be reassessed immediately for additional standard treatment. This approach could optimize outcomes by facilitating early sequential therapy for children with infantile spasms.
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