Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures

Sponsor
Tanta University (Other)
Overall Status
Completed
CT.gov ID
NCT03631901
Collaborator
(none)
60
1
2
17
3.5

Study Details

Study Description

Brief Summary

To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of recurrent simple febrile seizures.

Condition or Disease Intervention/Treatment Phase
  • Drug: oral melatonin
  • Drug: oral diazepam
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures: Randomized Clinical Trial
Actual Study Start Date :
Apr 1, 2017
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Melatonin

melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.

Drug: oral melatonin
Both melatonin and diazepam were given only during the febrile illness.

Active Comparator: Diazepam

oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.

Drug: oral diazepam
Both melatonin and diazepam were given only during the febrile illness.

Outcome Measures

Primary Outcome Measures

  1. recurrence of febrile seizures during febrile illness [6 months]

Secondary Outcome Measures

  1. side effect of medications reported in children [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University, Faculty of Medicine Tanta Egypt

Sponsors and Collaborators

  • Tanta University

Investigators

  • Principal Investigator: Amira Darwish, Tanta University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amira Hamed Darwish, Professor of pediatrics and Principal Investigator, Tanta University
ClinicalTrials.gov Identifier:
NCT03631901
Other Study ID Numbers:
  • TU2017
First Posted:
Aug 15, 2018
Last Update Posted:
Sep 12, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Amira Hamed Darwish, Professor of pediatrics and Principal Investigator, Tanta University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 12, 2019