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Randomized Trial of High Dose (4mg/kg) Versus Usual Dose (2mg/kg) Oral Prednisolone in the Treatment of Infantile Spasms.
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
Age
0 - 2 years
Sex
ALL
Healthy Volunteers
No
Lady Hardinge Medical College and Associated Kalawati Saran Children's Hospital
New Delhi, National Capital Territory of Delhi, India
Start Date
February 1, 2012
Primary Completion Date
February 1, 2013
Completion Date
March 1, 2013
Last Updated
April 9, 2013
63
ACTUAL participants
Oral prednisolone
DRUG
Lead Sponsor
Lady Hardinge Medical College
NCT06315829
NCT03976076
NCT00441896
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