Intermittent Levetricetam in Treatment of Febrile Convulsions

NCT05860153 | Unknown

• 1 other identifier: Febrile convulsions treatment
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The American Academy of Pediatrics (AAP) in 2011 published a clinical practice guideline defining a febrile seizure as "a seizure accompanied by fever (temperature ≥ 100.4°F or 38°C by any method), without central nervous system infection, that occurs in infants and children 6 through 60 months of age." Febrile seizures are further classified as simple (generalized in onset, last less than 15 minutes, and do not occur more than once in 24 hours.) or complex (FS duration longer than 15 min, repeated convulsions within the same day, and focal seizure activity or focal findings during the postictal period.).

Conditions

Febrile Convulsion

Outcome Measures

Primary Outcomes (2)

• The rate of therapeutic effect of oral levetiracetam on febrile convulsions

  The rate of therapeutic effect of oral levetiracetam in reducing the recurrence of febrile seizures in children aged 6-36months.

  Baseline

• The rate of therapeutic effect of intermittent diazepam on febrile convulsions

  The rate of therapeutic effect of intermittent diazepam in reducing the recurrence of febrile seizures in children aged 6-36months.

  Baseline

Study Arms (2)

Group (A)

EXPERIMENTAL

• Group (A) will receive oral levetiracetam at a dose of 15-20 mg/kg/day twice daily at the onset of fever (temperature \>37.5 c) for 48h after subsiding of fever.

Drug: Levetiracetam

Group (B)

EXPERIMENTAL

• Group (B) will receive diazepam at a dose of 0.3 mg/kg/dose was given every eight hours for 48h after subsiding of fever Children were followed up for 12 months to find out seizure frequency associated with febrile events and febrile seizure recurrence rate during 12 months follow-up

Drug: Diazepam

Interventions

Levetiracetam DRUG

Group with oral levetiracetam at a dose of 15-20 mg/kg/day

Also known as: Tiratam

Group (A)

Diazepam DRUG

Group with diazepam at a dose of 0.3 mg/kg/dose

Also known as: Valinil

Group (B)

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Non-febrile seizures
• Head trauma
• CNS infections
• Known metabolic diseases
• Known genetic disorders
• Developmental delay

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Seizures, Febrile

Interventions

Levetiracetam; Diazepam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Khaled Elsayah, Prof

  Assiut University

  PRINCIPAL INVESTIGATOR

• Khalaf Abd El-Aal, Assist prof

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kariman Hussein

CONTACT

01014121203; karimanhussein219@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: May 16, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05