Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention
NCT ID: NCT04364321
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
74 participants
INTERVENTIONAL
2020-05-13
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Single dose Clonazepam
Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius)
Clonazepam 0.5 MG
Clonazepam 0.02 mg/kg only one dose
Intermittent oral diazepam
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr) start at the time of body temperature more than 38 degree Celsius.
Diazepam Tablets
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)
Interventions
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Clonazepam 0.5 MG
Clonazepam 0.02 mg/kg only one dose
Diazepam Tablets
Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 3 or more episodes of clinically diagnosed febrile seizures
Exclusion Criteria
* history of previous brain insults; CNS infection, birth trauma, traumatic brain injury.
* delayed developmental milestones
* abnormal neurological examinations
* currently treatment by continous antiepileptic drug(s)
* A contraindication to Clonazepam, Diazepam such as drug hypersensitivity, liver disease.
* Predictable lack of available of follow up.
6 Months
60 Months
ALL
No
Sponsors
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Queen Sirikit National Institute of Child Health
OTHER_GOV
Responsible Party
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Kullasate Sakpichaisakul
Director of Pediatric Neurology
Principal Investigators
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Jinjutha Nithiuthai, MD
Role: PRINCIPAL_INVESTIGATOR
Queen Sirikit National Institute of Child Health
Locations
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Queen Sirikit National Institute of Child Health
Ratchathewi, Bangkok, Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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QSNICH63-017
Identifier Type: -
Identifier Source: org_study_id
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