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IRCT20190518043629N1 IRCT 2020-04-07 Tabriz University of Medical Sciences Evaluation of Melatonin Efficacy in Treatment of Respiratory Distress Syndrome and Prevention of Bronchopulmonary Dysplasia Evaluation of Melatonin Efficacy in Treatment of Respiratory Distress Syndrome and Prevention of Bronchopulmonary Dysplasia 2019-08-24 anticipated 80 Complete https://irct.ir/trial/40117 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The infants were randomly assigned to two groups. A random number list of 1 to 80 will be created using Random number generator and the infants will be randomly assigned to two intervention groups . The 1: 1 block randomization method will be used to achieve two groups with equal sample size, Blinding description: In this study,the physician visiting neonates is not aware receiving melatonin by neonates, the nurse who records the patients data and who perform data analysis are blind about study purposes. 3 Condition 1: respiratory distres syndrom. Condition 2: Bronchopolmonary displasia. Intervention 1: Control group: In this group, the surfactant is injected into the trachea. How to inject Surfactant by Insure, the patient will be intubated and post-injection will be extubated and subjected to N-CPAP but will remain intubated if the respiratory distress and SPO2 are not corrected. Intervention 2: Intervention group: In this group, after obtaining informed consent in addition to the surfactant, 5 mg / kg daily up to three days of melatonin will be administered via NGtube with the surfactant. Yes - There is a plan to make this available What will be shared: Information about the main outcome of this study is shared after unidentifiable individuals. When: After printing and analyzing the results and data available since 2021. To whom: The data of this study are applicable to academic and scientific researchers and medical and paramedical students. Conditions: The data in this study are solely for the use of academic and scientific researchers and medical and paramedical students. Where to obtain: Applicants can contact the following people by email: 1. Majid Fekri : majid.fekri1362@gmail.com 2 . Gharehbaghi : gharehbaghimm@yahoo.com How to obtain: The applicant can contact the Alzahra hospital in Tabriz in person or the e-mail address listed above. Comments:
public Majid Fekri
Artesh Ave
tabriz Iran (Islamic Republic of) 5138665793 +98 41 3556 9543 majid.fekri1362@gmail.com Tabriz University of Medical Sciences scientific Manijeh Mostafa Gharabaghi
Artesh Ave
Tabriz Iran (Islamic Republic of) 5138665793 +98 41 3556 9543 gharehbaghimm@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Premature Neonates between 26 and 32 weeks of age born at Al-Zahra Hospital Respiratory distress syndrome requires injection of surfactant 1 day 3 days Both Less than four minutes Apgar , fewer than four Evidence of congenital heart disease other than ASD and PDA Evidence of necrotizing antralocytosis before the administration of surfactant Congenital major anomalies, heart failure requiring treatment Shock Clear chromosomal abnormalities Esophageal atresia Diaphragmatic hernia P22.9 P27.1 Respiratory distress of newborn, unspecified Bronchopulmonary dysplasia originating in the perinatal period Treatment - Drugs Treatment - Drugs Control group: In this group, the surfactant is injected into the trachea. How to inject Surfactant by Insure, the patient will be intubated and post-injection will be extubated and subjected to N-CPAP but will remain intubated if the respiratory distress and SPO2 are not corrected. Intervention group: In this group, after obtaining informed consent in addition to the surfactant, 5 mg / kg daily up to three days of melatonin will be administered via NGtube with the surfactant. Bronchopulmonary dysplasia. Timepoint: Requires more than 21% oxygen for at least 28 days. Method of measurement: Fractional oxygen (Fio2) read by blender or ventilator and recorded in the file. Respiratory distress syndrome: Symptoms of respiratory distress due to surfactant deficiency mainly caused in preterm infants. Timepoint: One hour and four hours after treatment and the number of times the surfactant is needed. Method of measurement: Existence of respiratory distress requiring intubation or establishment of NCPAP with at least 5 cm water pressure at first hour of birth with Fractional oxygen (Fio2) requires respiratory fraction greater than 40% at 26 weeks gestation and respiratory fraction greater than 30% at 26 weeks gestation. Or continued respiratory distress, despite the onset of NCPAP, which is diagnosed by a neonatal or pediatric specialist or pediatric resident. Tabriz University of Medical Sciences Approved 2019-08-19 Ethics Committee for Research in Tabriz University of Medical Sciences ARTESH Ave Tabriz East Azarbaijan Iran (Islamic Republic of)