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Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose | Experimental | Oral Prednisolone will be given at dose of 4 mg/kg/day for 14 days |
|
| Usual dose | Active Comparator | Oral prednisolone will be given at dose of 2 mg/kg/day for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral prednisolone | Drug | Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children who achieved spasm freedom (for at least 48 hours) as per parental reports on day 14 . | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of children with adverse effects | 14 days |
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Inclusion Criteria:
- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satinder Aneja, MD | Lady Hardinge Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital | New Delhi | National Capital Territory of Delhi | 110001 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25048310 | Derived | Chellamuthu P, Sharma S, Jain P, Kaushik JS, Seth A, Aneja S. High dose (4 mg/kg/day) versus usual dose (2 mg/kg/day) oral prednisolone for treatment of infantile spasms: an open-label, randomized controlled trial. Epilepsy Res. 2014 Oct;108(8):1378-84. doi: 10.1016/j.eplepsyres.2014.06.019. Epub 2014 Jul 5. |
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| ID | Term |
|---|---|
| D013036 | Spasms, Infantile |
| ID | Term |
|---|---|
| D004829 | Epilepsy, Generalized |
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| D009422 |
| Nervous System Diseases |
| D000073376 | Epileptic Syndromes |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |