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

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ClinicalTrials.gov Identifier: NCT03631901
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Amira Hamed Darwish, Tanta University

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
Febrile Seizures 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2017
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Seizures

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.




Primary Outcome Measures :
  1. recurrence of febrile seizures during febrile illness [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. side effect of medications reported in children [ Time Frame: 6 months ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631901


Contacts
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Contact: Amira Darwish, MD +1026380311 amira.darwish@med.tanta.edu.eg

Locations
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Egypt
Tanta University, Faculty of Medicine Recruiting
Tanta, Egypt
Contact: Azza Kamal Al-shahawy, Professor of pediatrics       azzaalshahawy@gmail.com   
Sponsors and Collaborators
Tanta University
Investigators
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Principal Investigator: Amira Darwish Tanta University Hospital

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Responsible Party: Amira Hamed Darwish, Professor of pediatrics and Principal Investigator, Tanta University
ClinicalTrials.gov Identifier: NCT03631901     History of Changes
Other Study ID Numbers: TU2017
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amira Hamed Darwish, Tanta University:
Melatonin
Diazepam
recurrence
prophylaxis
Febrile convulsions

Additional relevant MeSH terms:
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Seizures
Fever
Seizures, Febrile
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Body Temperature Changes
Melatonin
Diazepam
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators