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IRCT20200414047072N2 IRCT 2020-11-06 The Children's Hospital & the Institute of Child Health, Multan. Efficacy and Safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm Comparison of efficacy and safety of corticosteroids and vigabatrin plus corticosteroids in infantile spasm: An open label randomized control trial 2020-08-10 anticipated 320 Complete https://irct.ir/trial/51602 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Its an open label randomized control trial design and Simple random sampling was occurred, where one group is taken single medicine while other group is taking medicine in combination. Individual unit of randomization where choose Total 320 infants (160 each group), according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system) will be included. Sealed opaque envelope system will be used for randomization. These pre- written, sealed envelopes will be opened at the time of start of treatment. real time physical random sequence will be done. N/A Infantile spasm. Intervention 1: Intervention group 1: Children will be divided into two groups by random allocation for the selection of treatment protocol. Group A children will receive prednisolone 40 mg/day in 4 divided doses along with an antacid, increased to 60 mg/day at day 8, if spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm). Intervention 2: Intervention group 2: Group B children will receive vigabatrin plus prednisolone (same protocol as of group A). Vigabatrin will be started with 50 mg/kg/day on day 1 increased to 100 mg/kg/day in two divided doses on day 2 for next three days followed by further increment to 150 mg/kg/day on day 5, if still spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm). They will also advised and trained to record any event that might be adverse reactions of vigabatrin or prednisolone. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is N/A
public Dr. Nuzhat Noureen
Ab'dali Road, Chowk Fawara, Mohalla Qadirabad, Multan, Punjab
Multan Pakistan 60000 +92 61 9201431 drnuzhatrana@gmail.com The Children's Hospital & the Institute of Child Health, Multan. scientific Dr. Nuzhat Noureen
Ab'dali Road, Chowk Fawara, Mohalla Qadirabad, Multan, Punjab
Multan Pakistan 60000 +92 61 9201431 drnuzhatrana@gmail.com The Children's Hospital & the Institute of Child Health, Multan. Pakistan Signed informed consent from parents/guardians Children aged one to 12 months Both genders with clinical diagnosis of infantile spasm made according to international league against epilepsy plus hypsarrhythmia on EEG (EEG records were graded using the Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system 1 month 12 months Both Infantile spasm due to tuberous sclerosis Previous treatment with steroids or vigabatrin Contraindication to steroids/vigabatrin (fever, active infection and hypertension). G40.822 Epileptic spasms, not intractable, without status epilepticus Other Other Intervention group 1: Children will be divided into two groups by random allocation for the selection of treatment protocol. Group A children will receive prednisolone 40 mg/day in 4 divided doses along with an antacid, increased to 60 mg/day at day 8, if spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm). Intervention group 2: Group B children will receive vigabatrin plus prednisolone (same protocol as of group A). Vigabatrin will be started with 50 mg/kg/day on day 1 increased to 100 mg/kg/day in two divided doses on day 2 for next three days followed by further increment to 150 mg/kg/day on day 5, if still spasm present. Symptomatic and supportive treatment will be provided simultaneously to both groups. All children will be physically followed at day 4, 7, 14, 21, 28, 42, 60, 90,120, 150 and 180 for efficacy and adverse drug reactions. Parents/ caregivers will be trained to maintain and complete a seizure diary including the detail of spasms (number, duration of spasm). They will also advised and trained to record any event that might be adverse reactions of vigabatrin or prednisolone. Electroclinical remission (cessation of spasms plus resolution ofhypsarrhythmia). Timepoint: Before intervention and Day 4, 7, 14, 21, 28, 42, 60, 90, 120, 150 and day 180. Method of measurement: Fundoscopy and blood pressure. EEG will be performed at day 0, 14, 42, 60, 90 and 180. Sleep EEG will be recorded for a minimum duration of 30 minutes according to international 10-20 system of electrode placement. Timepoint: day 0, 14, 42, 60, 90 and 180. Method of measurement: Burden of Amplitudes and Epileptiform Discharges (BASED) scoring system. Developmental assessment. Timepoint: day 0, 90 and 180. Method of measurement: portage early education program (PEEP). The Children's Hospital & the Institute of Child Health, Multan. Approved 2020-08-27 The Children's Hospital & the Institute of Child Health, Multan. Ab'dali Road, Chowk Fawara, Mohalla Qadirabad, Multan, Punjab Karachi Sindh Pakistan