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IRCT20200805048312N1 IRCT 2020-10-28 Tehran University of Medical Sciences The effect of inhaled Salbutamol on improvement of newborns with Respiratory distress syndrome The effect of inhaled Salbutamol (Ventolin) before intratracheal surfactant on the outcomes of Respiratory distress syndrome of newborn 2020-10-22 anticipated 62 Complete https://irct.ir/trial/50326 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After admission of newborns and diagnosis of respiratory distress syndrome, patient that candidate for administration of intertracheal surfactant willbe enter to the study. Patients randomly willbe allocate to control and intervention group. Random allocation willbe done by use of random number produced by digital calculator. If the number would be multiple of 2, patient willbe allocate in intervention group and if not, patient willbe allocate in control group, Blinding description: Before acceptance informed consent for participating in this study, parent willbe inform that wwhy and how, salbutamol willbe administrate for newborns. But Parent willnot be inform whether their baby receive Salbutamol or not. 3 Respiratory distress syndrome. Intervention 1: Intervention group: nebulizzing single dose of inhalational salbutamol (asthalin®) from Cipla (india) , 30 minute before injection of intratracheal surfactant. dosage : 0.2 mg per kg. Intervention 2: Control group: routine health care and treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Kamyar Kamrani
Shahid Kiyayi alley(Ghasemabad) , Damavand street, tehran
tehran Iran (Islamic Republic of) 1641744991 +98 21 7301 3000 kamyarkamrani48@gmail.com Tehran University of Medical Sciences scientific Kamyar Kamrani
Shahid Kiyayi alley(Ghasemabad) , Damavand street, tehran
tehran Iran (Islamic Republic of) 1641744991 +98 21 7301 3000 kamyarkamrani48@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Informed parent's consent Diagnosis of respiratory distress syndrome due to clinical and Para clinical data and candidation of interatrachial surfactant injection 1 day no limit Both Other respiratory disease such as Transient tachypnea of newborn, meconium aspiration,pneumonitis, congenital diaphragmatic hernia Arrhythmia, heart rate more than 180 5th minute respiratory apgar under 3 Congenital heart malformation, chromosomal malformation Asphyxia, severe hypoxia Birth trauma Hydrops Twin to twin transfusion Sepsis Severe Metabolic acidosis Electrolyte disorder, hypoglycemia, polycytemia History of maternal diabetes or asthma Death in first day of life Congenital tumors P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Intervention group: nebulizzing single dose of inhalational salbutamol (asthalin®) from Cipla (india) , 30 minute before injection of intratracheal surfactant. dosage : 0.2 mg per kg Control group: routine health care and treatment Oxygen saturation (%). Timepoint: at time of nebulizing of salbutamol and 30 minute after injection of intratracheal surfactant. Method of measurement: Pulse oxymetry. Arterial partial pressure of CO2 (PaCO2 ). Timepoint: at time of nebulizing of salbutamol and 30 minute after injection of intratracheal surfactant. Method of measurement: ABG test (Artrial blood gas). Length of hospitalization (days). Timepoint: at the time of discharging. Method of measurement: Patient file. Need for mechanical ventilation (duration). Timepoint: at the time of extubation. Method of measurement: Patient file. Need for continuous positive airway pressure (CPAP). Timepoint: at the time af discontinuing of CPAP. Method of measurement: Patient file. Outcome (death or live). Timepoint: at the time of discharging. Method of measurement: Patient file. Tehran University of Medical Sciences Approved 2020-09-24 Ethics committee of medical children's center 62 Qarib St. , Keshavarz Blvd., Tehran Tehran Tehran Iran (Islamic Republic of)