Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms
Not Applicable
- Conditions
- Infantile spasms
- Registration Number
- SLCTR/2010/010
- Lead Sponsor
- Department of Paediatrics Faculty of Medicine, Colombo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 136
Inclusion Criteria
• infants newly diagnosed with infantile spasms
• who have not been commenced on any treatment for infantile spasms
• between the ages of 1 month and 12 months
Exclusion Criteria
• Patients previously treated for infantile spasms
• Patients with tuberous sclerosis
• Patients with any contraindication to the use of steroids
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Spasm freedom/ spasm control- assessed using the spasm diary on day 14<br> [Outcome measure on day 14 developmental assessment at 6 months and 12 months]<br>Number of days taken for achieving spasm control [Outcome measure on day 14 developmental assessment at 6 months and 12 months ]<br>Comparison of the pre and post treatment EEGs for improvement (the repeat EEG will be performed during day 14-18) [Outcome measure on day 14 developmental assessment at 6 months and 12 months ]<br>Tolerance of the treatment arm without any complications/ need for withdrawal of therapy- will be assessed from the checklist of side effects [Outcome measure on day 14 developmental assessment at 6 months and 12 months ]<br>Developmental assessment at 6 and 12 months after initiating treatment. [Outcome measure on day 14 developmental assessment at 6 months and 12 months ]<br>
- Secondary Outcome Measures
Name Time Method Safety of the medication will be assessed as secondary outcome. This will be defined as a) number who develop serious adverse effects and B) number who had to take off the protocol due to ADRs.<br><br>Method of assessment: After the first 48 hours blood pressure, serum electrolytes and urinary sugars will be monitored in all. If BP is normal this will be rechecked on day 7 and day 14. At end of the 14 days of therapy a research assistant who will review the patient will go through a check list to document the side effects experienced. All adverse effects will be classified according to definitions used for phamacovigilence. [1. Blood pressure at 48 hours, day 7 and day 14 of therapy<br> 2. serum electrolytes and urinary sugars at 48 hours<br> 3. Adverse effects at day 14 of therapy<br>]<br>