Clinical Trial Protocol Iranian Registry of Clinical Trials

04 Oct 2021

Intermittent Diazepam versus Continuous Phenobarbital to Prevent Recurrence of Febrile Seizures: A Randomized Controlled trial

Protocol summary (Islamic Republic of) Phone Summary +98 11 3235 4951 Abstract Objective: To evaluate and compare the Email address preventive effect phenobarbital versus diazepam on [email protected] febrile seizure. Methods: This clinical trial was carried out Recruitment status on 154 children that admitted in Amirkola children Recruitment complete hospital. Inclusion criteria included children with age of 6 Funding source month to 5 yr old who had recurrent simple FC or Vice- Chancellor for Research Technology Affairs, complex FC and were without of history consumption University of Medical Sciences anticonvulsive drugs. Intervention: Children were divided into two groups: The first group received in the prophylaxis of oral diazepam 0.33 mg/ kg, three times in Expected recruitment start date a day for the first two days of febrile illness and the 2008-03-20, 1387/01/01 second group received in the prophylaxis of oral Expected recruitment end date phenobarbital 3-5 mg/kg once day for at least a year. 2010-03-21, 1389/01/01 Main outcome: The patients were followed for 12-18 Actual recruitment start date months (average 13 months) for recurrence of FC via empty phone calls to parents Actual recruitment end date empty Trial completion date General information empty

Acronym Scientific title - Intermittent Diazepam versus Continuous Phenobarbital IRCT registration information to Prevent Recurrence of Febrile Seizures: A Randomized IRCT registration number: IRCT2015080223393N2 Controlled trial Registration date: 2015-09-27, 1394/07/05 Registration timing: retrospective Public title Intermittent Diazepam versus Continuous Phenobarbital to Prevent Recurrence of Febrile Seizures: A Randomized Last update: Controlled trial Update count: 0 Purpose Registration date Treatment 2015-09-27, 1394/07/05 Inclusion/Exclusion criteria Inclusion criteria: Age of 6 months to 5 yr old; with Registrant information recurrent simple FC; complex FC without of history Name consumption anticonvulsive drugs Exclusion criteria: Mohammadreza Salehiomran Children with history of neonatal seizure; seizure without Name of organization / entity fever; chronic disease related electrolytes imbalance; Babol University of Medical Sciences history of anticonvulsive consumption Country Age

1 From 6 months old to 5 years old G90,G91,G9 Gender ICD-10 code description Both Other disorders of the nervous system

Phase 2 Primary outcomes Groups that have been masked No information Sample size 1 Target sample size: 145 Description Randomization (investigator's opinion) Prevention of recurrence of FC. N/A Timepoint Randomization description Were followed for 18-12 months Blinding (investigator's opinion) Method of measurement Not blinded Phone follow up Blinding description Placebo Not used Secondary outcomes Assignment empty Parallel Other design features - Intervention groups

Secondary Ids 1 Description 1 Diazepam as tablets, 2 and 5 mg and up to 10 mg per Registry name day based on a dose of thirty-three hundredths mg per - kg was administered and the patient's family about drug Secondary trial Id prescription was explained, regardless of age and sex of - the patients just one among the patients who were given Registration date the drug to patients. empty Category Treatment - Drugs Ethics committees 2 1 Description Ethics committee Phenobarbital form of tablets 15 and 60 mg and a dose Name of ethics committee of 3 to 5 mg per kg intravenously (according to weight Babol University of Medical Sciences Ethics patients require administration of oral 100 mg Committee phenobarbital or 10 mg of diazepam was not), Street address phenobarbital, are one among the patients were given Vice- Chancellor for Research Technology Affairs, continuous course but only in the first 2 days of febrile Babol University of Medical Sciences, Ganjafroz illness was recommended diazepam Street, Babol, , IR Iran Babol Category City Treatment - Drugs Babol Postal code 4731741151 Recruitment centers Approval date 2010-09-23, 1389/07/01 1 Ethics committee reference number 1111 Recruitment center Name of recruitment center Health conditions studied Amirkola Children’s Hospital Full name of responsible person Dr Mohammadreza Salehiomran 1 Street address Description of health condition studied Babol/Amirkola siezure City ICD-10 code Babol/Amirkola

2 Sponsors / Funding sources -

1 Person responsible for scientific inquiries Sponsor Name of organization / entity Contact Vice- Chancellor for Research Technology Affairs, Name of organization / entity Babol University of Medical Sciences Amirkola Children’s Hospital Full name of responsible person Full name of responsible person Dr Ali Akbar Moghadamnia Dr Mohammadreza Salehiomran Street address Position Vice- Chancellor for Research Technology Affairs, Pediatric Neurologist/Associate professor Babol University of Medical Sciences, Ganjafroz Other areas of specialty/work Street, Babol, Mazandaran Province, IR Iran. Street address City No 19, Amirkola Children’s Hospital, Amirkola, Babol, Babol/Amirkola Mazandaran Province, IR Iran. Grant name City - Babol/Amirkola Grant code / Reference number Postal code - 4731741151 Is the source of funding the same sponsor Phone organization/entity? +98 11 3235 4951 Yes Fax Title of funding source +98 11 3234 6963 Vice- Chancellor for Research Technology Affairs, Babol Email University of Medical Sciences [email protected] Proportion provided by this source Web page address 100 - Public or private sector empty Person responsible for updating data Domestic or foreign origin empty Contact Category of foreign source of funding Name of organization / entity empty Non-Communicable Pediatric Diseases Research Country of origin Center Type of organization providing the funding Full name of responsible person empty Sajedeh Hajipour Goli Position Person responsible for general inquiries BS Other areas of specialty/work Contact Street address Name of organization / entity No 19, Amirkola Children’s Hospital, Amirkola, Babol, Amirkola Children’s Hospital Mazandaran, Iran Full name of responsible person City Mohammadreza Salhiomran Babol/Amirkola Position Postal code Pediatric Neurologist 4731741151 Other areas of specialty/work Phone Street address +98 113246963 No 19, Amirkola Children’s Hospital, Amirkola, Babol, Fax Mazandaran Province, Iran +98 11 3234 6963 City Email Babol/Amirkola hajipour1365@gmailcom Postal code Web page address 4731741151 - Phone +98 113254951 Sharing plan Fax +98 11 3234 6963 Deidentified Individual Participant Data Set (IPD) Email empty [email protected] Study Protocol Web page address empty

3 Statistical Analysis Plan empty empty Analytic Code Informed Consent Form empty empty Data Dictionary Clinical Study Report empty

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