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IRCT20230526058294N1 IRCT 2023-08-19 Shahid Beheshti University of Medical Sciences The effect of melatonin in the prevention of bronchopulmonary dysplasia in neonates admitted to Neonatal intensive care unit of Mahdieh Hospital The effect of melatonin in the prevention of bronchopulmonary dysplasia in neonates admitted to Neonatal intensive care unit 2023-04-20 anticipated 300 Complete https://irct.ir/trial/70556 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of patients in two groups was done by random block allocation method.The allocation sequence was generated using the free web system https//:www.sealedenvelope.com.To produce the sequence, the number of subjects in each block is 4, and the letters A are for the intervention group and the letters B are for the control group.Finally, 60 samples (15 blocks) have been produced in two groups A and B.Then, the cards containing the blocks are placed inside the standard envelope and in this way the concealment allocation is observed. Based on the selection of eligible neonates, an envelope is randomly picked by the researcher and the method of allocation is determined, Blinding description: The doctor evaluating the outcome does not know how to assign drugs to patients. After collecting all the samples, the data analyst will analyze the intervention and control groups based on the code made by the pharmacologist. 3 bronchopulmonary dysplasia. Intervention 1: Intervention group: In the intervention group, in addition to surfactant, melatonin drops at a dose of 0.1 milligram per kilogram of the baby's weight will be administered as oral drops for three days. Intervention 2: Control group: In the control group, in addition to intratracheal surfactant, placebo drops similar to melatonin are prescribed.Placebo drops prepared by a pharmacologist and containing normal saline are prescribed. Yes - There is a plan to make this available What will be shared: Data can be shared potentially after patients became unrecognizable. When: After completing the results and analyzing the data, access to them is allowed. To whom: Researchers working in academic institutions or research centers Conditions: Researchers are licensed by the research committee Where to obtain: After publishing the article, visit the magazine site to get more information write to f.serati128@gmail.com How to obtain: Researchers can can receive the necessary response after two weeks by sending an e-mail to the person in charge. Comments:
public fatemeh serati
Fadaeiyan Eslam
tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 f.serati128@gmail.com Shahid Beheshti University of Medical Sciences scientific fatemeh serati
Fadaeiyan Eslam.Mahdiyeh Hospital
tehran Iran (Islamic Republic of) 1185817311 +98 21 5506 2628 f.serati128@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Premature neonates between 26 and 32 weeks with respiratory distress syndrome need surfactant injection 1 day 3 days Both Apgar five minutes less than four Evidence of necrotizing enterocolitis before surfactant administration chromosomal disorders, esophageal atresia, diaphragmatic hernia Evidence of congenital heart diseases other than Atrial Septal Defect and Patent ductus arteriosus Major congenital anomaly of heart failure requiring treatment P27.1 Bronchopulmonary dysplasia originating in the perinatal period Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, in addition to surfactant, melatonin drops at a dose of 0.1 milligram per kilogram of the baby's weight will be administered as oral drops for three days. Control group: In the control group, in addition to intratracheal surfactant, placebo drops similar to melatonin are prescribed.Placebo drops prepared by a pharmacologist and containing normal saline are prescribed. BRONCHOPULMONARY DYSPLASIA. Timepoint: Before initiation of the study, 28 and 56 days after birth. Method of measurement: Inspiratory oxygen fraction:The percentage of oxygen that is present in the air of the newborn, in order to investigate respiratory distress syndrome, the need for oxygen or respiratory assistance for more than 28 days after birth to investigate bronchopulmonary dysplasia. Shahid Beheshti University of Medical Sciences Approved 2023-02-20 کمیته اخلاق در پژوهش‌های زیست پزشکی دانشگاه علوم پزشکی شهیدی بهشتی Shariati St. Mofid Children's Hospital tehran Tehran Iran (Islamic Republic of)