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Role of clobazam prophylaxis in children with fits/seizures following fever.

A randomized Double Blind Placebo Controlled Trial To Evalvate The Efficacy Of Intermittent Clobazam Prophylaxis In Simple Febrile Convulsions.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/05/013898
Enrollment
184
Registered
2018-05-15
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- simple febrile convulsion

Interventions

Intervention1: clobazam: one group was prescribed clobazam (in form of sachet labelled A ) so that investigator and patient remain blind . DOSE: 5 mg OD PO if wt upto 5 kg 5 mg BD PO if wt 6-10 kg 7.5

Sponsors

DEPARTMENT OF PAEDIATRICS DrSN MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1-Children with one or more episodes of febrile seizures aged 6 months to 5 years will be recruited as per working definition of simple febrile convulsion mentioned in introduction. 2-The seizures should be generalized and should have occurred within 24 hours of onset of fever.

Exclusion criteria

Exclusion criteria: 1-Children with history suggestive of febrile seizure and proved to have an acute CNS infection. 2-Abnormal electroencephalogram, developmental retardation. 3-Proven CNS malformation, progressive neurological disease. 4-Proven chromosomal abnormalities 5-Those on any anticonvulsant medication

Design outcomes

Primary

MeasureTime frame
Primary Outcome measures: 1. No. of febrile episodes in both groups . 2. Frequency of recurrence of febrile seizure . Timepoint: one year

Secondary

MeasureTime frame
Secondary outcome measures: 1. Adverse effect profile of drug . 2. Recurrence in relation to age ,family history ,gender . Timepoint: one year

Countries

India

Contacts

Public ContactVINOD KUMAR

Dr.S.N.MEDICAL COLLEGE JODHPUR RAJASTHAN

drpramodsha@hotmail.com9929744666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026