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CTRI Number  CTRI/2024/03/063676 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised controlled trial to study efficacy of intermittent seizure prophylaxis with Clobazam in patients of complex febrile seizures already on continuous sodium valproate prophylaxis. 
Scientific Title of Study   Evaluation of intermittent Clobazam prophylaxis in children aged 6 months to 5 years with Complex Febrile Seizures already on continuous prophylaxis with Sodium Valproate ; a randomized control trial  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Awnish Kumar Mishra 
Designation  JR 2 Paediatrics 
Affiliation  Armed forces medical college 
Address  Dept Of Paediatrics AFMC PUNE

Pune
MAHARASHTRA
411040
India 
Phone  8087385994  
Fax  8087385994  
Email  AWNIAVI@GMAIL.COM  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Yadav 
Designation  Head Of Department 
Affiliation  Command Hospital Southern Commond 
Address  Dept Of Paediatrics Command Hospital Southern Command PUNE

Pune
MAHARASHTRA
411040
India 
Phone  9969034427  
Fax    
Email  drashokyadavpaed@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Awnish Kumar Mishra 
Designation  JR 2 Paediatrics 
Affiliation  Armed forces medical college 
Address  Dept Of Paediatrics AFMC PUNE

Pune
MAHARASHTRA
411040
India 
Phone  8087385994  
Fax  8087385994  
Email  AWNIAVI@GMAIL.COM  
 
Source of Monetary or Material Support  
ARMED FORCES MEDICAL COLLEGE PUNE-411040 
 
Primary Sponsor  
Name  Armed forces medical college 
Address  Dept Of Paediatrics, Armed forces medical college Pune-411040 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
ARMED FORCES MEDICAL COLLEGE  Dept Of Paediatrics, Armed Forces Medical College, Pune-411040 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Awnish Kumar Mishra  COMMAND HOSPITAL SOUTHERN COMMAND   Room no 244, Service OPD complex Dept Of Paediatrics 1st Floor, B1/B2 block Command Hospital Southern Command Pune-411040
Pune
MAHARASHTRA 
8087385994

awniavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, ARMED FORCES MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R560||Febrile convulsions,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTERMITTENT CLOBAZAM PROPHYLAXIS  The patients’ attendant will be instructed to administer clobazam in group A(intervention arm) during the febrile episodes irrespective of the child’s risk for recurrence of seizures according to weight (<5kg-2.5 mg twice daily, >5-10 kg-5 mg BD, 10-15 Kg-7.5 mg BD, >15 Kg-10 mg BD) for 72 hrs/6 doses 
Comparator Agent  NIL  Standard prophylaxis of sodium Valproate and antipyretics will be continued 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  All children aged 06 months- 5years, with complex febrile
seizures, already on continuous valproate prophylaxis for minimum of 1 month presenting to Pediatric or Pediatric Neurology OPD or admitted in Pediatric ward 
 
ExclusionCriteria 
Details  Patients presenting with
1)afebrile seizures,
2) Combination of febrile seizures with afebrile seizures
3) Genetically proven channelopathies.
4) Global developmental delay
5) Congenital malformations
6)Cause of fever being intracranial infection
7) Chid with deranged renal or hepatic functions
8)On antiseizure medications other than sodium valproate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Estimate the incidence of seizure recurrence with febrile episode  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Ascertain incidence of adverse effects of adjuvant intermittent clobazam prophylaxis.  6 months 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   11/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [awniavi@gmail.com].

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 01-06-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Febrile seizures are the most common types of seizure among children, with aprevalence of 2–5% in children aged less than 5 years.

Most cases occur between 3 months and 5 years of age with peak age of 14–18 months. It accounts for approximately 25% of childhood status epilepticus

Febrile seizures frequently recur, with a recurrence rate of 50%, when the first attack occurs before one year of age. In general, one third of infants will develop a second attack following subsequent febrile illness; half of the latter group will experience a third febrile seizure as well. Febrile seizures recurs 3 or more times in 10% of cases

More than one half of recurrences are experienced during the first year and over 90% develop within two years, following the first attack, with the higher risk within the first 6 to 12 months.

The likelihood for recurrence is greater among infants who convulse at temperatures below 40°C. The risk of recurrence is about 30% for simple febrile seizures and over 50% for complex febrile seizures.

Treatment of Febrile seizures consists of controlling the convulsions with anticonvulsants in dosages analogous to those recommended for the treatment of status epilepticus, reduction of the body temperature via conductive or evaporative cooling of the patient and treatment of the acute infection responsibleThis high recurrence rate of 30–50% and family anxiety rationalize the prophylaxis to prevent further episodes. Many times these complex febrile seizures evolve to

Epilepsy with cognitive and behavioural [problems later in childhood as per the present evidence of literature.

In India, the incidence of FS differs due to reports of different community based studies. The incidence of FS is reported 0.5–10.1% from a single study from South India, 17.7/1000 population from a survey in Bombay and a prevalence rate of 330/10,000 population in a population based neuroepidemiological survey in Bangalore

Complex febrile seizures are defined as as those with focal onset, prolonged duration (greater than 10–15 min), or those that occur more than once within the same febrile illness [10, 11]. Approximately 20 % of FS cases are classified as CFS.Their is growing body of evidence that continuos prophylaxis needs to be given in children with Complex febrile seizures.

Intermittent/ Continuous Valproate, with or without intermittent clobazam is one of the regimes used with varying success. There are no studies available to showthe efficacy of adding/not adding clobazam intermittently in a child with complex febrile seizures already on continuous prophylaxis with various antisezure medications of which valproate is preferred by most physicians and Pediatric Neurologists.

Despite being on Continous prophylaxis many physcians advice intermittent prophylaxis over and above the continuous prophylaxis which needs to be studied and refuted or recommended based on the evidence.

Hence we feel that this needs to be studied in a systematic manner as an RCT.

 
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