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IRCT2017053034219N1 IRCT 2017-07-20 Research Department of Jondi Shapoor University of Medical Sciences, Ahvaz The effect of inhalant budesonide with surfactant prescription in the treatment of respiratory distress syndrome in premature infants Comparison of intratracheal injection of surfactants with and without prescription of inhalant budesonide on the clinical course of premature newborns weighing less than 1500 grams with respiratory distress syndrome in the neonatal intensive care unit. A randomized clinical trial. 2017-06-10 anticipated 74 Complete https://irct.ir/trial/26201 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A neonatal respiratory distress syndrome. Intervention 1: In the intervention group: budesonide (Pulmicort vials, product of Astrazenca Co., Canada) 0.25 mg / kg as endotracheal nebulizer immediately after standard treatment. Intervention 2: The standard treatment control group: Curosurf surfactant Manufactured by Cheisi Co., Italy, at a rate of 2.5 ml/kg initially, and an extra dose of 1.5 ml/kg, if necessary.
public Dr. Meisam Reza Boghrati
Golestan boulevard, university campus
Ahvaz Iran (Islamic Republic of) +98 61 3336 1948 research@ajums.ac.ir Jondi Shapoor University of Medical Sciences, Ahvaz scientific Reza Babapour
Golestan boulevard, university campus
Ahvaz Iran (Islamic Republic of) +98 61 3336 1948 research@ajums.ac.ir Jondi Shapoor University of Medical Sciences, Ahvaz Iran (Islamic Republic of) Inclusion criteria: (All of the following) premature infants weighing less than 1500 grams; have respiratory distress syndrome; require a surfactant; treated with CPAP and with FIo₂> 40%. exclusion criteria:Infants weighing less than 1000 grams; more than 2 twin pregnancies; pregnancies with birth trauma; congenital anomalies; perinatal asphyxia; neonatal transfers from other institutions. no limit 7 days Both P22 Respiratory distress of newborn Treatment - Drugs Treatment - Drugs In the intervention group: budesonide (Pulmicort vials, product of Astrazenca Co., Canada) 0.25 mg / kg as endotracheal nebulizer immediately after standard treatment The standard treatment control group: Curosurf surfactant Manufactured by Cheisi Co., Italy, at a rate of 2.5 ml/kg initially, and an extra dose of 1.5 ml/kg, if necessary Duration of respiratory support required. Timepoint: The first two weeks after the intervention. Method of measurement: Recording of the time between the onset and the end of respiratory support. Duration of additional oxygen requirement. Timepoint: The first two weeks after the intervention. Method of measurement: Recording of the time between the onset and the end of oxygen therapy. Length of stay in hospital. Timepoint: one month. Method of measurement: The time between admission and the beginning of the intervention until the end of the intervention and discharge from the hospital. The number of deaths. Timepoint: one month. Method of measurement: The number of cases of intervention or control that died during the study. - - Research Department of Jondi Shapoor University of Medical Sciences, Ahvaz Approved 2017-04-22 Ethic committee development of Research and Technological Department of Jondi Shapoor University of University Campus - Department of Development and Research, Ground floor ahvaz Iran (Islamic Republic of)