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IRCT20110807007244N10 IRCT 2023-09-19 Mashhad University of Medical Sciences Comparison of the effects of topiramate and azithromycin on the balance of antioxidants, interleukin 6, 8 and 1 in infants with cerebral complications of birth asphyxia Comparison of the effect of azithromycin and topiramate on prooxidant antioxidant balance, interleukin 6, 8 and 1 in infants with hypoxic-ischemic encephalopathy 2024-02-20 anticipated 124 Recruiting https://irct.ir/trial/72503 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The block method will be used as a reliable randomization method that leads to balanced allocation of people in treatment groups at the end of each block. https://www.sealedenvelope.com/simple-randomiser/v1/lists is used to prepare random blocks with variable sizes. The output of the site is such that, depending on the number of samples and the proposed sizes of the blocks, a certain number of blocks with different sizes (4 and 8) and with different sequences of block content is provided, which is followed by the content of each block in a sealed envelope and then one of the blocks is randomly selected and depending on the order of the sequence, the person in question is placed in one of the arms of the study. In the same way, after the completion of the first block, the second block is randomly selected and this continues until the last block and assigning the last person to the study arms. As a rule, by assigning the last sheet of the last block, the patients are grouped equally in the two arms of the study and the balance between the groups is established, Blinding description: The first layer of blinding occurs in the group of participants in such a way that after obtaining informed consent from the parents, no information regarding the therapeutic process of the infant will be provided to them. Given that the infants are kept in the NICU and away from their parents, medication will be administered at times when the parents are not present. The second layer pertains to the outcome evaluator, who will only have access to the names of the participants and will have no information regarding the patient's medication card. Finally, the collected data from both study groups A and B will be delivered to the analyst, who will have no information regarding the allocation of titles A and B to the intervention and control groups. 3 Hypoxic Ischemic encephalopathy. Intervention 1: Intervention group: infants suffered from hypoxic ischemic encephalopathy who receive azithromycin ( 20 mg/kg/day, orally for 3 days and then 10 mg/kg/day, orally for 2 ) and/or Topiramate( 10 mg/kg/day, orally for 3 days ). Intervention 2: Control group: infants who receive conventional treatments (respiratory support, fluid management, anticonvulsant drugs, reduction of intracranial pressure, maintenance of blood pressure and correction of hypoglycemia, acidosis and electrolyte disorders). Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: available for people working in academic institutions Conditions: upon reasonable request from corresponding author Where to obtain: Boskabadih@mums.ac.ir How to obtain: If there is a need for the data for another research project, access to the data is possible, provided that the intellectual rights of the authors, the financial provider, and the rights of the project are respected. Comments:
public Hassan Boskabadi
Ahmadabad St,
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 2069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences scientific Hasan Boskabadi
Ahmadabad St.
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3841 2069 Boskabadih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) History of identifiable birth events (placenta separation, uterine rupture, umbilical cord prolapse) along with birth monitoring disorders Umbilical cord pH less than 7 or less than 7.2 in the blood sample in the first hour of birth BE<-12 in umbilical cord blood sample in the first hour of birth The need for positive pressure ventilation for more than one minute in the delivery room no limit no limit Both Congenital malformations maternal chorioamnionitis Intrauterine growth retardation P91.60 Hypoxic ischemic encephalopathy [HIE], unspecified Treatment - Drugs Treatment - Drugs Intervention group: infants suffered from hypoxic ischemic encephalopathy who receive azithromycin ( 20 mg/kg/day, orally for 3 days and then 10 mg/kg/day, orally for 2 ) and/or Topiramate( 10 mg/kg/day, orally for 3 days ) Control group: infants who receive conventional treatments (respiratory support, fluid management, anticonvulsant drugs, reduction of intracranial pressure, maintenance of blood pressure and correction of hypoglycemia, acidosis and electrolyte disorders) Pro oxidant antioxidant balance. Timepoint: The beginning of the study. Method of measurement: Pro-Oxidant Antioxidant Balance (PAB) assay. Interleukin 6. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay. Interleukin 8. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay. Interleukin 1 B. Timepoint: The beginning of the study. Method of measurement: Enzyme-linked immunosorbent assay. Pro-Oxidant Antioxidant Balance. Timepoint: Three days after birth. Method of measurement: Pro-Oxidant Antioxidant Balance assay. Interleukin 6. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay. Interleukin 8. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay. Interleukin 1B. Timepoint: Three days after birth. Method of measurement: Enzyme-linked immunosorbent assay. Mashhad University of Medical Sciences Approved 2023-10-24 IR.MUMS.MEDICAL.REC.1402.276 ahmadabad St Mashhad Razavi Khorasan Iran (Islamic Republic of)