| 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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [awniavi@gmail.com].
- 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.
- 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. |