drugset / Trial / NCT04364321
Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention
RandomizedParallel-groupTriple-blindPrevention
Summary
To study the efficacy and safety of single dose clonazepam compared with intermittent oral diazepam for prevention of recurrent febrile seizures in children who had three or more febrile seizures.
Timeline
- Start
- 2020-05-13
- Primary completion
- 2023-06
- Completion
- 2023-06
Publications
- Background Berg AT, Shinnar S, Darefsky AS, Holford TR, Shapiro ED, Salomon ME, Crain EF, Hauser AW. Predictors of recurrent febrile seizures. A prospective cohort study. Arch Pediatr Adolesc Med. 1997 Apr;151(4):371-8. doi: 10.1001/archpedi.1997.02170410045006.
- Background Berg AT, Shinnar S, Hauser WA, Leventhal JM. Predictors of recurrent febrile seizures: a metaanalytic review. J Pediatr. 1990 Mar;116(3):329-37. doi: 10.1016/s0022-3476(05)82816-1.
- Background Kolfen W, Pehle K, Konig S. Is the long-term outcome of children following febrile convulsions favorable? Dev Med Child Neurol. 1998 Oct;40(10):667-71. doi: 10.1111/j.1469-8749.1998.tb12326.x.
- Background Visser AM, Jaddoe VW, Ghassabian A, Schenk JJ, Verhulst FC, Hofman A, Tiemeier H, Moll HA, Arts WF. Febrile seizures and behavioural and cognitive outcomes in preschool children: the Generation R study. Dev Med Child Neurol. 2012 Nov;54(11):1006-11. doi: 10.1111/j.1469-8749.2012.04405.x. Epub 2012 Sep 3.
- Background Bertelsen EN, Larsen JT, Petersen L, Christensen J, Dalsgaard S. Childhood Epilepsy, Febrile Seizures, and Subsequent Risk of ADHD. Pediatrics. 2016 Aug;138(2):e20154654. doi: 10.1542/peds.2015-4654. Epub 2016 Jul 13.
- Background Billstedt E, Nilsson G, Leffler L, Carlsson L, Olsson I, Fernell E, Gillberg C. Cognitive functioning in a representative cohort of preschool children with febrile seizures. Acta Paediatr. 2020 May;109(5):989-994. doi: 10.1111/apa.15059. Epub 2019 Nov 10.
- Results Rosman NP, Colton T, Labazzo J, Gilbert PL, Gardella NB, Kaye EM, Van Bennekom C, Winter MR. A controlled trial of diazepam administered during febrile illnesses to prevent recurrence of febrile seizures. N Engl J Med. 1993 Jul 8;329(2):79-84. doi: 10.1056/NEJM199307083290202.
- Results Knudsen FU. Recurrence risk after first febrile seizure and effect of short term diazepam prophylaxis. Arch Dis Child. 1985 Nov;60(11):1045-9. doi: 10.1136/adc.60.11.1045.
- Results Capovilla G, Mastrangelo M, Romeo A, Vigevano F. Recommendations for the management of "febrile seizures": Ad Hoc Task Force of LICE Guidelines Commission. Epilepsia. 2009 Jan;50 Suppl 1:2-6. doi: 10.1111/j.1528-1167.2008.01963.x.
- Results Offringa M, Newton R, Cozijnsen MA, Nevitt SJ. Prophylactic drug management for febrile seizures in children. Cochrane Database Syst Rev. 2017 Feb 22;2(2):CD003031. doi: 10.1002/14651858.CD003031.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clonazepam | Small molecule | 0.02 mg/kg | Oral |
| Comparator | Diazepam | Small molecule | 0.3 mg/kg | — |