Comparison of the effect of azithromycin and topiramate on prooxidant antioxidant balance, interleukin 6, 8 and 1 in infants with hypoxic-ischemic encephalopathy

Determining the effect of azithromycin or topiramate on IL-6, IL-8 and PAB in infants with hypoxic ischemic encephalopathy

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 124 patients

This clinical trial will be conducted on infants with hypoxic ischemic encephalopathy hospitalized in the hospitals of Mashhad University of Medical Sciences. After obtaining informed consent from the mothers and completing the informed consent form, infants with a gestational age of more than 32 weeks are included in the study.

Criteria for individuals' entry into the study: Infants with a gestational age of 32 weeks or more and a definitive diagnosis of hypoxic-ischemic encephalopathy, which includes at least two of the following: History of identifiable birth events (placenta separation, uterine rupture, umbilical cord prolapse) along with birth monitoring disorders, birth trauma, or difficult birth. Umbilical cord pH less than 7 or blood pH less than 7.2 in the blood sample within the first hour of birth. BE > -12 in the blood sample within the first hour of birth or umbilical cord. Non-entry criteria: congenital malformation, maternal chorioamnionitis

Infants who entering the study are,, in the four arms of the study as follows: Control group: infants who receive conventional treatment and are under care. Group receiving allopurinol: in addition to conventional measures, 40 mg/kg allopurinol tablets (with a time interval of 12 hours) on the first day. Erythropoietin receiving group: In this group, erythropoietin is prescribed at a dose of 1000 IU/kg on the first, second and third day. The group receiving erythropoietin and allopurinol together

Changes in the PAB, interleukin 6 and 8 before and after intervention

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.

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.

IPD collected for the primary outcome measure only

starting 6 months after publication

available for people working in academic institutions

upon reasonable request from corresponding author

Boskabadih@mums.ac.ir

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.