IRCT20230605058385N1 IRCT 2023-09-02 Mashhad University of Medical Sciences melatonin in neonates with hypoxic encephalopathy Investigating the effect of melatonin in pro-oxidant antioxidant balance of neonates with hypoxic ischemic encephalopathy: A Randomized Parallel Clinical Trial 2023-09-01 anticipated 70 Complete https://irct.ir/trial/70563 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the upcoming clinical trial, we will utilize block randomization to ensure a balanced allocation between the intervention and control groups. A computer algorithm from the website sealedenvelope.com will generate blocks of a predetermined size (e.g., 4 or 6). Within each block, an equal number of participants will be allocated to both the intervention and control groups. Sealed, numbered envelopes will be used for this purpose. Instead of containing a drug or placebo, each envelope will simply have a label indicating the group—either "Control" or "Intervention"—to which the participant is to be allocated. These envelopes will be distributed to participants based on the block randomization algorithm generated by sealedenvelope.com. An independent team separate from the principal investigators will manage this process to ensure that the randomization is executed accurately and without bias, 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. 1-2 Hypoxic ischemic encephalopathy [HIE]. Intervention 1: Intervention group: infants suffered from hypoxic ischemic encephalopathy who receive Melatonin ( 10 mg/kg/day, orally for 5 days). Intervention 2: Control group: infants suffered from hypoxic ischemic encephalopathy who do not receive Melatonin. 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: