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IRCT20211006052685N2 IRCT 2022-07-12 Shiraz University of Medical Sciences Comparison of endotracheal tube and thin catheter for surfactant therapy in neonates with respiratory distress syndrome RDS: respiratory distress syndrome Comparison of two methods of endotracheal tube and thin catheter for surfactant therapy in neonates with respiratory distress syndrome in NICU 2022-01-05 anticipated 80 Complete https://irct.ir/trial/62637 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each group. The number of samples assigned to each group is equal, and we will have 80 participants in each group. The size of all blocks is equal, and in this two-group experiment, we will have 10 blocks (including 8 participants in the intervention group and 8 participants in the control group). The drug will then be given to patients based on the blocks obtained and in the order of allocation. For randomization, it also uses random allocation software that this random sequence generation software, in addition to simple randomization, can generate a random sequence by blocking method, Blinding description: The blinding method in this study will be single-blind. The single-blind is used to reduce bias related to the intervention and evaluate the consequences. In this study, the data analyzer will not be informed about grouping. 3 Respiratory distress syndrome. Intervention 1: Intervention group 1: In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The first group will receive surfactant by INSURE and ETT method. Neonates in this group were first intubated, and then surfactant was administered to them through a suitable tracheal tube. For infants, surfactant was administered slowly through the endotracheal tube (ETT). The administration was stopped if the surfactant returned to the ETT or the patient showed signs of intolerance. Patients were extubated immediately after finishing surfactant administration through INSURE. The dosage of surfactant in this method was also 100 mg/kg. Intervention 2: Intervention group 2:In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The second group will receive surfactant by MIST technique. A 5 Fr polyurethane catheter was used for these infants. Direct laryngoscopy or video laryngoscopy was used if needed, according to the doctor's opinion. The required depth for babies with a weight ≥ 1 kg was calculated using the baby's weight (kg) plus 6. The required depth for babies < 1 kg was considered between 5.5 and 6 cm. During the intervention, sedatives and painkillers were not prescribed. Infants were under CPAP during the intervention. The dosage of surfactant in this method was 100 mg/kg. 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 obtaining the results, a decision is made
public Mehrdad Rezaei
Zand street, Nemazee hospital
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4298 md_rezaie@yahoo.co.uk Shiraz University of Medical Sciences scientific Mehrdad Rezaei
Zand street, Nemazee hospital
Shiraz Iran (Islamic Republic of) 7193711351 +98 71 3647 4298 md_rezaie@yahoo.co.uk Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Infants born with a gestational age of 25 to 37 weeksA dmitted to the NICU 1 day 30 days Both Respiratory distress due to cardiac causes hemodynamic instability sepsis and any cause other than surfactant deficiency P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Intervention group 1: In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The first group will receive surfactant by INSURE and ETT method. Neonates in this group were first intubated, and then surfactant was administered to them through a suitable tracheal tube. For infants, surfactant was administered slowly through the endotracheal tube (ETT). The administration was stopped if the surfactant returned to the ETT or the patient showed signs of intolerance. Patients were extubated immediately after finishing surfactant administration through INSURE. The dosage of surfactant in this method was also 100 mg/kg Intervention group 2:In this study, Beraksurf surfactant (Teksima Pharmaceutical Company, Iran) was used to treat newborns. The concentration of phospholipids in Beraksurf is 25 mg/ml. The second group will receive surfactant by MIST technique. A 5 Fr polyurethane catheter was used for these infants. Direct laryngoscopy or video laryngoscopy was used if needed, according to the doctor's opinion. The required depth for babies with a weight ≥ 1 kg was calculated using the baby's weight (kg) plus 6. The required depth for babies < 1 kg was considered between 5.5 and 6 cm. During the intervention, sedatives and painkillers were not prescribed. Infants were under CPAP during the intervention. The dosage of surfactant in this method was 100 mg/kg. Treatment of respiratory distress syndrome. Timepoint: Evaluate respiratory condition of neonates at birth up to 30 days after birth. Method of measurement: Evaluate the duration and amount of need for mechanical ventilation, NCPAP and FiO2. Shiraz University of Medical Sciences Approved 2022-01-04 Ethics committee of Shiraz University of Medical Sciences Zand street, Shiraz university of medical sciences, Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)