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IRCT20211107052993N1 IRCT 2021-11-21 Iran University of Medical Sciences Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD) Concomitant intratracheal administration of surfactant and budesonide in the prevention of bronchopulmonary dysplasia (BPD) compared with surfactant alone in the treatment of respiratory distress syndrome in preterm infants. 2021-11-10 anticipated 296 Complete https://irct.ir/trial/59889 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Premature infants with symptoms of Respiratory Distress Syndrome are randomly assigned to one of two groups of control (surfactant) or intervention (surfactant plus budesonide) according to random numbers extracted from the computer. To assign each person to the study arms, a random list will be prepared by visiting the sealed envelope site. This site allows us to have a random list at the beginning of the study to assign people to study groups, Blinding description: After obtaining informed written consent from the parents of premature infants with symptoms of Respiratory Distress Syndrome, they are randomly assigned to one of two groups of control (surfactant) or intervention (surfactant plus budesonide) according to random numbers extracted from the computer. The grouping is in a sealed envelope and is opened by the pharmacy, and the doctor receives the medicine in a syringe that has been drawn and is ready for injection and injects it into the trachea. The relevant nurse and physician who records the patient information checklist will not be aware of the baby's grouping. The doctor involved in the treatment of infants does not know the grouping of infants. 3 Condition 1: Bronchopulmonary dysplasia. Condition 2: Respiratory Distress syndrome. Intervention 1: Intervention group: Simultaneous intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight) and budesonide (budesonide at a dose of 0.25 mg / kg body weight). Intervention 2: Control group: intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight. Yes - There is a plan to make this available What will be shared: Sharing information about the main outcome When: 6 months after publication To whom: Physicians working in scientific and academic institutions Conditions: For research purposes Where to obtain: a.aminyan@yahoo.com How to obtain: Request by email with job description Comments:
public Arezoo Aminyan daryasari
Naft building 264, Zafar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1918613436 +98 13 4222 9638 a.aminyan@yahoo.com Iran University of Medical Sciences scientific Arezoo Aminyan daryasari
Naft building 264, Zafar Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1918613436 +98 13 4222 9638 a.aminyan@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Premature infants with a Gestational age less than 37 weeks weighing less than 1,500 g Premature infants admitted to the Neonatal ward due to Respiratory distress syndrome based on clinical and radiological symptoms and negative blood culture at birth; And receives any non-invasive respiratory support, and requires a surfactant injection at the physician's discretion. no limit 30 days Both Congenital major anomalies that affect the baby's breathing Existence of asphyxia; (Apgar score less than 7 in 5 minutes of birth) Parental dissatisfaction Gastrointestinal abnormalities that cause the baby to be transferred to another center Congenital cyanotic heart disease P27.1 P22.0 Bronchopulmonary dysplasia originating in the perinatal period Respiratory distress syndrome of newborn Prevention Treatment - Drugs Intervention group: Simultaneous intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight) and budesonide (budesonide at a dose of 0.25 mg / kg body weight) Control group: intratracheal injection of surfactant (braksurf with an initial dose of 4 cc per kg body weight Bronchopulmonary dysplasia. Timepoint: daily , end of 6 week or discharge time. Method of measurement: clinical. Duration of auxiliary oxygen reception. Timepoint: daily , end of 6 week or discharge time. Method of measurement: clinical. Iran University of Medical Sciences Approved 2021-06-12 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)