Randomized Clinical Trial on Prednisolone Vs ACTH for the treatment of Infantile Spasms

Authors
Category Primary study
Registry of TrialsSLCTR
Year 2010
INTERVENTION: They will undergo detailed evaluation for aetiology, development and a digital electroencephalogram with video monitoring will be performed. Following randomization they will be commenced on the therapy consisting of oral prednisolone or intramuscular adrenocorticotropin homone, and will be monitored closely for side effects CONDITION: Infantile spasms PRIMARY OUTCOME: 1. Spasm freedom/ spasm control‐ assessed using the spasm diary on day 14; 2. Number of days taken for achieving spasm control; 3. Comparison of the pre and post treatment EEGs for improvement (the repeat EEG will be performed during day 14‐18); 4. Tolerance of the treatment arm without any complications/ need for withdrawal of therapy‐ will be assessed from the checklist of side effects; 5. Developmental assessment at 6 and 12 months after initiating treatment. SECONDARY OUTCOME: 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. ; 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. 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
Epistemonikos ID: 57643bf5acb7d589366decc6511169fc4647c9bd
First added on: Aug 22, 2024