Single Dose of Clonazepam Versus Intermiittent Diazepam for Febrile Seizures Prevention

NCT04364321 | Unknown

• 1 other identifier: QSNICH63-017
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Febrile Convulsion

Keywords

recurrent febrile convulsions; Clonazepam; prophylaxis

Outcome Measures

Primary Outcomes (1)

• Recurrent rate of febrile seizures

  Rate of seizure occurs when the children have febrile illnesses (at the onset of fever until fever gone). The seizures will be reported by their parents/caregivers. (via the seizure record form and the interview.) Statistic analysis: Cumulative incidence (person-year). percent. Comparison between the two group by unpaired t test.

  the assessment will be done at 12 months after enrollment

Secondary Outcomes (8)

• Number of participants with adverse reaction of medications

  7 days

• Associated factors: Sex

  at the enrollment.

• Associated factors: age at first febrile seizure

  at the enrollment

• Associated factors: the lowest temperature that cause seizure

  at the enrollment.

• Number of participants with febrile convulsions in parents or siblings

  at the enrollment.

Study Arms (2)

Single dose Clonazepam

EXPERIMENTAL

Clonazepam(0.5 mg/tablet) 0.02 mg/kg orally once at the time of fever present. (body temperature more than 38 degree Celsius)

Drug: Clonazepam 0.5 MG

Intermittent oral diazepam

ACTIVE COMPARATOR

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.

Drug: Diazepam Tablets

Interventions

Clonazepam 0.5 MG DRUG

Clonazepam 0.02 mg/kg only one dose

Also known as: Rivotril, Povanil

Single dose Clonazepam

Diazepam Tablets DRUG

Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)

Intermittent oral diazepam

Eligibility Criteria

• Age: 6 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age 6-60 months at date of enrollment
• or more episodes of clinically diagnosed febrile seizures

You may not qualify if:

• history of afebrile seizures or any history suggested the epilepsy
• 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.

Sponsors & Collaborators

• Queen Sirikit National Institute of Child Health: lead

Study Sites (1)

Queen Sirikit National Institute of Child Health

Ratchathewi, Bangkok, 10400, Thailand

RECRUITING

Related Publications (10)

• 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.

  PMID: 9111436 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.

  PMID: 2137875 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.

  PMID: 9851235 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.

  PMID: 22937894 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.

  PMID: 27412639 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.

  PMID: 31618476 BACKGROUND

• 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.

  PMID: 8510706 RESULT

• 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.

  PMID: 3907504 RESULT

• 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.

  PMID: 19125841 RESULT

• 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.

  PMID: 28225210 RESULT

MeSH Terms

Conditions

Seizures, Febrile

Interventions

Clonazepam; Diazepam

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jinjutha Nithiuthai, MD

  Queen Sirikit National Institute of Child Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinjutha Nithiuthai, MD

CONTACT

66806218033; jinjutha.nt@gmail.com

Sirorat Suwannachote, MD

CONTACT

6623548333; sirorat.s@rsu.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pediatric Neurology

Model Details: A pragmatic parallel group randomized trial comparing single dose clonazepam with intermittent oral diazepam for prevention recurrent febrile seizures

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 28, 2020
• Study Start: May 13, 2020
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)