Back to resultsComparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
Primary Purpose
Febrile Seizures
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
oral melatonin
oral diazepam
Sponsored by
About this trial
This is an interventional prevention trial for Febrile Seizures focused on measuring Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
Eligibility Criteria
Inclusion Criteria:
- Children aged 6 months to 5 yrs .
- Simple febrile seizures
Exclusion Criteria:
- Complex febrile seizures
- Child with history of neonatal seizure.
- Afebrile seizures.
- History of anticonvulsive therapy.
- Children suffering from epilepsy.
- Children with abnormal EEG.
- Children with abnormal neurological examination.
- Positive family history of epilepsy.
Sites / Locations
- Tanta University, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Melatonin
Diazepam
Arm Description
melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.
Outcomes
Primary Outcome Measures
recurrence of febrile seizures during febrile illness
Secondary Outcome Measures
side effect of medications reported in children
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03631901
Brief Title
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
Official Title
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.
Detailed Description
To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrence of simple febrile seizures in children aged 6 months to 5 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Seizures
Keywords
Melatonin, Diazepam, recurrence, prophylaxis, Febrile convulsions
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Melatonin
Arm Type
Active Comparator
Arm Description
melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.
Arm Title
Diazepam
Arm Type
Active Comparator
Arm Description
oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.
Intervention Type
Drug
Intervention Name(s)
oral melatonin
Intervention Description
Both melatonin and diazepam were given only during the febrile illness.
Intervention Type
Drug
Intervention Name(s)
oral diazepam
Intervention Description
Both melatonin and diazepam were given only during the febrile illness.
Primary Outcome Measure Information:
Title
recurrence of febrile seizures during febrile illness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
side effect of medications reported in children
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children aged 6 months to 5 yrs .
Simple febrile seizures
Exclusion Criteria:
Complex febrile seizures
Child with history of neonatal seizure.
Afebrile seizures.
History of anticonvulsive therapy.
Children suffering from epilepsy.
Children with abnormal EEG.
Children with abnormal neurological examination.
Positive family history of epilepsy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amira Darwish
Organizational Affiliation
Tanta University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tanta University, Faculty of Medicine
City
Tanta
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
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