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IRCT20210412050944N1 IRCT 2021-06-01 Qazvin University of Medical Sciences Consequences of intratracheal administration of surfactant and surfactant with budesonide Comparative survey of the consequences of intratracheal administration of surfactant and surfactant with budesonide in premature infants with respiratory distress syndrome 2021-06-24 anticipated 50 Complete https://irct.ir/trial/56080 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Randomization of patients will be done by randomization of 4 blocks (AA, BB-AB, AB-BA, BA-AA, BB). Exactly equal numbers of participants enter the groups at consecutive but equal intervals. Therefore, two groups are considered. In intervention group A patients, for 25 infants with respiratory distress syndrome, Sorvanta at a dose of 100 mg / kg and in intervention group B, for 25 infants with respiratory distress syndrome, Survanta at a dose of 100 mg/kg with budosonide 0.25 mg is administered intratracheally. The administration for each group should be repeated 6 hours after the first administration. If necessary, the treatment period is completed within 4 days. Before and after administration, neonates are tested for ABG (Arterial blood gas) separately in each group. They are then monitored for mechanical ventilation management every 12 hours. The necessary information for the study will be collected using a checklist and finally the consequences of the prescription between the two groups will be analyzed and compared, Blinding description: In this study, health care personnel (physicians, nurses, physiotherapists, etc.) who are responsible for caring for patients and infants (or parents of infants) are blind. N/A Respiratory Distress Syndrome. Intervention group 1: In infants that are under nasal continuous positive airway pressure and ventilator, gradually flow continues increase to CDP = 6 inches, H2O and FiO2 = 30%. A requirement of FiO2 more than 40% to maintain oxygen saturation in the range of 90 to 95%, survanta with budosonide 0.25 mg intratracheally is prescribed at a dose of 100 mg / kg and the infant is included in the study. If the infant needs more than 40% FiO2 to maintain acceptable oxygen saturation, survanta should be repeated 6 hours after the first administration. If necessary, the treatment period (4 days) is complete. Before and after the administration the mechanical ventilation management of infants is monitored for arterial blood gas and every 12 hours monitored for arterial blood gas and every 12 hours, Intervention group 2: In infants that are under nasal continuous positive airway pressure and ventilator, gradually flow continues increase to CDP = 6 inches, H2O and FiO2 = 30%. A requirement of FiO2 more than 40% to maintain oxygen saturation in the range of 90 to 95%, survanta with budosonide 0.25 mg intratracheally is prescribed at a dose of 100 mg / kg and the infant is included in the study. If the infant needs more than 40% FiO2 to maintain acceptable oxygen saturation, survanta should be repeated 6 hours after the first administration. If necessary, the treatment period (4 days) is complete. Before and after the administration, the mechanical ventilation management of infants is monitored for arterial blood gas and every 12 hours.. 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 After analyzing the information, it will be published as statistical data only in the article.
public Fatemeh Tohidnia
Qazvin, Shahid Beheshti Blvd, Beginning of East Palestine, Qods Square, Qods Educational and Medical Center
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3332 8709 cgd_rc@yahoo.com Qazvin University of Medical Sciences scientific فاطمه توحیدنیا
Qazvin, Shahid Beheshti Blvd, Beginning of East Palestine, Qods Square, Qods Educational and Medical Center
Qazvin Iran (Islamic Republic of) 59811-34197 +98 28 3332 8709 cgd_rc@yahoo.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Infants that have clinical signs of respiratory distress syndrome. Infants that their ages are have 2 weeks. Infants receiving nasal continuous positive airway pressure with surfactant. 1 day 14 days Both Infants that have congenital anomalies. Infants that have perinatal asphyxia. Treatment - Drugs Intervention group 1: In infants that are under nasal continuous positive airway pressure and ventilator, gradually flow continues increase to CDP = 6 inches, H2O and FiO2 = 30%. A requirement of FiO2 more than 40% to maintain oxygen saturation in the range of 90 to 95%, survanta with budosonide 0.25 mg intratracheally is prescribed at a dose of 100 mg / kg and the infant is included in the study. If the infant needs more than 40% FiO2 to maintain acceptable oxygen saturation, survanta should be repeated 6 hours after the first administration. If necessary, the treatment period (4 days) is complete. Before and after the administration the mechanical ventilation management of infants is monitored for arterial blood gas and every 12 hours monitored for arterial blood gas and every 12 hours, Intervention group 2: In infants that are under nasal continuous positive airway pressure and ventilator, gradually flow continues increase to CDP = 6 inches, H2O and FiO2 = 30%. A requirement of FiO2 more than 40% to maintain oxygen saturation in the range of 90 to 95%, survanta with budosonide 0.25 mg intratracheally is prescribed at a dose of 100 mg / kg and the infant is included in the study. If the infant needs more than 40% FiO2 to maintain acceptable oxygen saturation, survanta should be repeated 6 hours after the first administration. If necessary, the treatment period (4 days) is complete. Before and after the administration, the mechanical ventilation management of infants is monitored for arterial blood gas and every 12 hours. Percentage of infants with respiratory distress syndrome. Timepoint: Before the intervention and every 12 hours after the administration of surfactant in the intervention group and surfactant with budosonide 0.25 mg intratracheally in the control group. Method of measurement: Mechanical Ventilation Device. Reduction of respiratory distress syndrome in preterm infants prescribed with surfactant and surfactant with budesonide. Timepoint: Before the intervention and every 12 hours after the administration of surfactant in the intervention group and surfactant with budosonide 0.25 mg intratracheally in the control group. Method of measurement: Mechanical Ventilation Devices. Qazvin University of Medical Sciences Approved 2021-02-02 Ethics Committee of Qazvin University of Medical Sciences Quds Educational and Medical Center, Beginning of East Palestine Ave., Shahid Beheshti Blvd., Qazvin City Qazvin Qazvin Iran (Islamic Republic of)