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IRCT20200109046061N2 IRCT 2023-07-21 Shahid Beheshti University of Medical Sciences Comparing the effectiveness of melatonin with placebo in reducing the level of interleukin-6 in operated infants. Comparing the effectiveness of melatonin with placebo in reducing the level of interleukin-6 in operated infants. 2023-08-01 anticipated 40 Complete https://irct.ir/trial/70466 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Simple randomization in the form of sequential production, where the number of subjects in each block is set to 4, and letters A are for the intervention group and letters B are considered for the control group. Finally, 20 samples (5 blocks) were produced in both groups A and B, then the cards containing the blocks were placed inside the standard envelope, thus concealing the allocation of compliance Based on the referral of eligible infants, an envelope will be taken by the researcher and the method of allocation will be determined, Blinding description: Blinding of the clinical caregiver who gives the medicine to the newborns, who randomly put the medicine in the caregiver's possession and will not know the contents of the medicine, and the analyzer will not know about the contents of the envelope. 3 Severity of inflammation in operated babies. Intervention 1: Intervention group: The melatonin used in this intervention is Emivital drops from Amin company and contains one milligram of melatonin in each cc. Intervention 2: Control group: Placebo, which is administered with the same amount of drug (melatonin) 0.1 mg/kg of normal saline for 3 days from the day before surgery to two days after surgery. Yes - There is a plan to make this available What will be shared: Patient information, including the rate of therapeutic response to melatonin to reduce the inflammatory factor in infants undergoing surgery, and how to use melatonin and placebo drugs, which are recorded by a questionnaire and finally analyzed, and the informed consent of the parents of the infants indicating that the company in the study can be shared, but the names of the participants in the study to protect the patient's privacy. It is not placed. When: The beginning of the access period is after the end of the registration of the results. To whom: It will be available for everyone Conditions: To access this study, use the keywords melatonin, interleukin-6 and surgery Where to obtain: Submit your requests by email to dr.elnaznobakht@gmil.com How to obtain: The request should be sent to the email of the person responsible for the study Comments:
public Elnaznobakht
Saadat Abad, Blvdria, Moj St., 6 West Tawheed Alley
Tehran Iran (Islamic Republic of) 1466975699 +98 21 8617 5194 dr.elnaznobakht@gmail.com Shahid Beheshti University of Medical Sciences scientific Elnaznobakht
Saadat Abad, Blvdria, Moj Alley, 6 West Tawheed St
Tehran Iran (Islamic Republic of) 1466975699 +98 21 8617 5194 dr.elnaznobakht@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age limit below one month Hospitalized for surgery Consent of the family to participate in the plan 1 day 30 days Both Treatment - Drugs Placebo Intervention group: The melatonin used in this intervention is Emivital drops from Amin company and contains one milligram of melatonin in each cc. Control group: Placebo, which is administered with the same amount of drug (melatonin) 0.1 mg/kg of normal saline for 3 days from the day before surgery to two days after surgery. The effect of melatonin on reducing the level of interleukin 6. Timepoint: Day before surgery. Day three after surgery. Method of measurement: Kate Eliza. Shahid Beheshti University of Medical Sciences Approved 2023-06-25 Ethics committee of Shahid Beheshti University of Medical Scienses ​Look up details 64 / 5,000 Translation results Translation result Tehran, Shariati St. above Hosseinieh Ershad Mofid Children's Hospital Tehran Tehran Iran (Islamic Republic of)