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IRCT20211226053528N2 IRCT 2022-09-21 Iran University of Medical Sciences The effect of melatonin in the prevention of retinopathy of prematurity The effect of melatonin in the prevention of retinopathy of prematurity in preterm neonates 2021-12-22 anticipated 60 Complete https://irct.ir/trial/65579 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method is used and the block size is 6. The website https://www.sealedenvelope.com is used to generate random sequences. Each participant is assigned a sequence. Then, each participant was randomly assigned to one of the arms of the study (A or B). The random sequence is given to the epidemiologist of the study, and every patient who enters the study, the doctor will contact him to find out whether the person will enter group A or B, Blinding description: After random allocation, the randomized list will be placed in sealed envelopes. In this way, the first doctor will be blinded to assigning people to treatment groups. Regarding to ophthalmologist does not know about the treatments provided, he will be blind. 3 Retinopathy of Prematurity. Intervention 1: Intervention group: Babies receive melatonin softgel (Nutralab under license of Canada) daily at dosage of 3 mg/ kg/day until 37 weeks. Intervention 2: Control group: This group of neonatess gets only routine treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamid Khalilian
No.193, Zafar St, Modares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 hkhalilian1410@gmail.com Iran University of Medical Sciences scientific Nastaran Khosravi
No.193, Zafar St, Modares Highway
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 khosravi.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Parents satisfaction to participate in the study Premature newborns under 34 weeks Lack of congenital anomalies Lack of genetic disorder, metabolic disorder or suffering from TORCH Lack of intraventricular hemorrhage (grade 3 and 4) 1 day 7 days Both Intraventricular hemorrhage (grade 3 and 4) during patients follow up Incidence of gastrointestinal complications such as NEC during treatment if it is not possible to take the medicine orally. Taking less than 14 days of melatonin H35.1 Retinopathy of prematurity Treatment - Drugs Treatment - Drugs Intervention group: Babies receive melatonin softgel (Nutralab under license of Canada) daily at dosage of 3 mg/ kg/day until 37 weeks. Control group: This group of neonatess gets only routine treatment Stopping of abnormal blood vessels formation in the retina. Timepoint: End of 37 weeks and end of 44 weeks. Method of measurement: Examination by retina fellowship and with ophthalmoscope. Iran University of Medical Sciences Approved 2021-12-13 Ethics committee of Iran University of Medical Sciences Hemmat Highway, Next to the Milad Tower Tehran Tehran Iran (Islamic Republic of)