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IRCT20200131046317N1 IRCT 2020-02-17 Mashhad University of Medical Sciences Comparison of the effects of high doses of prednisolone and ACTH on the treatment of infantile spasms Comparison of the effects of high doses of prednisolone and ACTH on the treatments of infants with infantile spasms 2020-01-29 anticipated 92 Complete https://irct.ir/trial/45523 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is conducted through table of random numbers available at 'www.randomization.com' website where numbers are placed in sealed envelopes assigning patients to one of the two groups, Blinding description: The analyst will be unaware of the intervention and control groups. 2-3 Infantile spasm. Intervention 1: Intervention group: patients will be treated with high doses of prednisolone tablets under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of nisopred where at the beginning, the treatment will start with 8 mg/kg in 3 doses with a maximum of 60 mg daily for two weeks and in case of appropriate response (no seizure up to 24 hours), treatment with prednisolon with 6 mg/kg in 3 doses per 8 hours will continue for 5 days and then, 4 mg/kg in 2 doses per 12 hours for another 5 days and next, 2 mg/kg daily for the last 5 days will be prescribed. In all stages, the maximum dosage is 60 mg daily. Intervention 2: Control group: Intramuscular injection of ACTH under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of synacran with the dosage of 2 to 3 units/kg daily for 5 days and next prednisolone tablet under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of nisopered with dosage of 2 mg/kg daily for 3 weeks and every other day for the rest of the treatment will be prescribed. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data will be available for researchers in universities and other scientific institutes. Conditions: Carrying out analysis on data is permitted. Where to obtain: Data can be accessible through sending an email to the corresponding author. How to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. Comments:
public Shima Iman Nezhad
Ghaem Hospital, Ahmad Abad Avenue
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2496 shiimaa83@gmail.com Mashhad University of Medical Sciences scientific Javad Akhondian
Ghaem hospital, Ahmad Abad Ave.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3801 2496 akhondianj@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with infantile spasm within the age range of 2 to 12 month Abnormal Electroencephalography where seizures started a most one month ago with no control over seizures 2 months 12 months Both Previous use of corticosteroids or ACTH in any way Known metabolic cause Brain structural disorder, active infections, history of hypertension and history of heart and kidney diseases G99 Other disorders of nervous system in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: patients will be treated with high doses of prednisolone tablets under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of nisopred where at the beginning, the treatment will start with 8 mg/kg in 3 doses with a maximum of 60 mg daily for two weeks and in case of appropriate response (no seizure up to 24 hours), treatment with prednisolon with 6 mg/kg in 3 doses per 8 hours will continue for 5 days and then, 4 mg/kg in 2 doses per 12 hours for another 5 days and next, 2 mg/kg daily for the last 5 days will be prescribed. In all stages, the maximum dosage is 60 mg daily. Control group: Intramuscular injection of ACTH under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of synacran with the dosage of 2 to 3 units/kg daily for 5 days and next prednisolone tablet under the brand of Iran Hormone Pharmaceutical Corporation and the trade name of nisopered with dosage of 2 mg/kg daily for 3 weeks and every other day for the rest of the treatment will be prescribed. Seizures status. Timepoint: Two weeks after the commencement of the treatment. Method of measurement: Based on parents' reports. Electroencephalography. Timepoint: Before treatment and two weeks after commencement of the treatment. Method of measurement: Conducting electroencephalography. Mashhad University of Medical Sciences Approved 2019-12-05 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)