]>
IRCT20171030037093N38 IRCT 2020-05-08 Esfahan University of Medical Sciences Effect of Budesonide with Surfactant on the prevention of chronic lung disease in premature infants Effect of Budesonide plus Surfactant in prevention of chronic lung disease in premature infants with gestational age less than 30 weeks 2020-04-20 anticipated 190 Complete https://irct.ir/trial/46854 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to randomize the study, simple randomization with individual unit is used, so that patients randomly select one of the cards containing the codes A or B so they enter one of the two treatment groups. 3 Chronic lung disease. Intervention 1: Intervention group: Babies in need of surfactant receive exogenous surfactant + budesonide solution 0.25 mg / kg or 0.5 cc / kg which is injected into the face via an intratracheal catheter. Each infant is given only one dose of budesonide. Intervention 2: Control group: Infants who need surfactants receive exogenous surfactants which are injected into the face via an intratracheal catheter. 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 I will decide until finishing the study
public Amir-Mohammad Armanian
Department of Pediatrics, Isfahan Medical School, Isfahan, Iran
isfahan Iran (Islamic Republic of) 7346181746 0098 31 6255555 armanian@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amir-Mohammad Armanian
Department of Pediatrics, Isfahan Medical School, Isfahan, Iran
isfahan Iran (Islamic Republic of) 7346181746 0098 31 6255555 armanian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Premature infants with pre-existing GA <30 weeks admitted to the NICU Receives some kind of non-invasive respiratory support including CPAP and physician decides to prescribe surfactant no limit 7 months Both Major congenital anomalies affecting neonatal respiration (severe pulmonary hypoplasia, congenital lung abnormality, congenital airway obstruction) Asphyxia Gastrointestinal anomalies that cause the baby to be transferred to another center Sepsis before starting the study Cyanotic heart disease P27.8 Other chronic respiratory diseases originating in the perinatal period Treatment - Drugs Placebo Intervention group: Babies in need of surfactant receive exogenous surfactant + budesonide solution 0.25 mg / kg or 0.5 cc / kg which is injected into the face via an intratracheal catheter. Each infant is given only one dose of budesonide. Control group: Infants who need surfactants receive exogenous surfactants which are injected into the face via an intratracheal catheter. The time required for mechanical ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list. The period of time of no need for non-invasive ventilation. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list. Duration of hospital stay. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list. The period of time of surfactant injections. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list. The condition of chronic lung disease. Timepoint: 4 to 6 weeks after birth. Method of measurement: Check list. Esfahan University of Medical Sciences Approved 2020-01-05 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar jarib st, Isfahan Isfahan Isfehan Iran (Islamic Republic of)