Comparison Between Melatonin and Diazepam for Prevention... | NCT03631901

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

NCT03631901

Sponsor

Tanta University

Status

Completed

Last Update Posted

Sep 12, 2019Actual

Enrollment

60Actual

Phase

Phase 4

Conditions

Febrile Seizures

Interventions

oral melatonin
oral diazepam

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2017Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Aug 13, 2018

First Submission Date that Met QC Criteria

Aug 13, 2018

First Posted Date

Aug 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2019

Last Update Posted Date

Sep 12, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Amira Hamed Darwish, Professor of pediatrics and Principal Investigator, Tanta UniversityPrincipal Investigator

Lead Sponsor

Tanta UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin	Active Comparator	melatonin 0.3mg/kg/8 hours, orally. Given only during the febrile illness.	Drug: oral melatonin
Diazepam	Active Comparator	oral diazepam 1mg/kg/day divided into 3 doses. Given only during the febrile illness.	Drug: oral diazepam

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral melatonin	Drug	Both melatonin and diazepam were given only during the febrile illness.	Melatonin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence of febrile seizures during febrile illness		6 months

Secondary Outcomes

Measure	Description	Time Frame
side effect of medications reported in children		6 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amira Darwish	Tanta University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tanta University, Faculty of Medicine		Tanta			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003294	Seizures, Febrile
D012008	Recurrence

Ancestor Terms

ID	Term
D012640	Seizures
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008550	Melatonin
D003975	Diazepam

Ancestor Terms

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

Browse Leaves

Not provided

Browse Branches

Not provided