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IRCT20120126008827N3 IRCT 2022-01-09 Shiraz University of Medical Sciences Evaluation of the effect of Beraksurf and Cursorf in patients with respiratory distress Comparison of therapeutic effects of Iranian surfactant (Beraksurf) with Cursorf in premature infants with respiratory distress admitted to the neonatal intensive care unit of Hafez and Namazi hospitals in Shiraz in 1400 2021-12-22 anticipated 100 Complete https://irct.ir/trial/9314 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: En In this study, we will use the limited randomization method of block randomization, which is used to balance the number of participants in each study group. The size of the blocks is equal, and we will have 50 participants in each group. For block randomization, the size of the blocks is considered to be five. According to the sample size, 20 blocks will be selected based on a table of random numbers. The individuals are assigned to groups based on the position of the blocks. Random allocation concealment will be done using randomly sealed opaque envelopes. The random allocation sequence was computer-generated (Kendall and Smith's Random Numbers Table) by a statistician who was not a part of the research team. A random number table is a series of digits (0 to 9) arranged randomly in rows and columns, as demonstrated in the small sample below. The table usually contains 5-digit numbers, arranged in rows and columns, for ease of reading. The random allocation sequence was concealed in sealed opaque envelops until the participants were assigned into two groups participants were assigned into two groups, 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, samples of the research are blinded (parents know about the study drugs, but they will not be informed about grouping. 3 respiratory distress syndrome. Intervention 1: Intervention group 1: In this group, 50 neonates with RDS diagnosis will receive intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 2.5 cc/ kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed. Intervention 2: Intervention group 2: In this group, 50 neonates with RDS diagnosis will receive intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc/kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed. 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 Not data gathering
public Khadijeh Sadat Najib
Nemazee hospital, Nemazee square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 1647 4298 nzahrasan@yahoo.com Shiraz University of Medical Sciences scientific Khadijeh Sadat Najib
Nemazee hospital, Nemazee square, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 1647 4298 nzahrasan@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Gestational age < 37 weeks Radiologic and clinical diagnosis during first 6 hours, Need to Fio2>30% for keeping o2 saturation 92-95% that measured by pulse oximetry no limit no limit Both Patients with congenital disease and anomalies Receiving two types of surfactant due to lack or shortage of the drug Patients need operation Neonates with congenital heart or lung disease or abdominal pathology P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Intervention group 1: In this group, 50 neonates with RDS diagnosis will receive intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 2.5 cc/ kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed. Intervention group 2: In this group, 50 neonates with RDS diagnosis will receive intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc/kg (200 mg/kg) every 6-12 hours until the Fio2 is less than 30%. For subsequent doses,100 mg/kg will be given up to three doses every 6 hours if needed. Treatment of respiratory distress syndrome. Timepoint: evaluate respiratory condition of neonates at birth and 2, 6,12,18,24,36,48 and 72 hour after birth. Method of measurement: Beraksurf case report form. Shiraz University of Medical Sciences Approved 2021-10-30 Ethics committee of Shiraz University of Medical Sciences Zand street, Shiraz University of Medical Sciences, Shiraz Shiraz Fars Iran (Islamic Republic of)