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IRCT20200529047594N1 IRCT 2020-06-08 Iran University of Medical Sciences Comparison of efficacy & safety of Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS) Comparison of efficacy & safety of intratracheal Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS) 2020-01-22 anticipated 90 Complete https://irct.ir/trial/48577 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Newborns are assigned to three groups: bracsurf (group A), survanta (group B) and Curosurf (group c). There are six possible block sequences of block size 3. Possible combinations include ABC, ACB, BAC, BCA, CAB, CBA. Initially, one of the compounds is randomly selected, and 3 individuals are assigned to each block. This process is repeated many times to include the eligible sample size, Blinding description: In this study, samples of the research are blinded (parents know about the study drugs, but they will not be informed about grouping A, B & c). 3 Respiratory Distress Syndrome (RDS). Intervention 1: Intervention group: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. Intervention 2: Intervention group 2: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Survanta (produced by ABBOT, US) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. Intervention 3: Intervention group 3: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. 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 There is no further information
public Niknaz Kabiri
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 kabiri.n@iums.ac.ir Iran University of Medical Sciences scientific Majid Kalani
Molavi Ave, AkbarAbadi Hospital.
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 kalani.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Parents consent to participate study premature neonates with a gestational age of less than 34 weeks premature neonates with diagnosis of RDS and candidates for surfactant A maximum of 8 hours have elapsed since the birth 1 day 2 days Both No parents consent to participate study Newborns with congenital heart diseases and other life threatening congenital anomalies. Adverse drug effects P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. Intervention group 2: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Survanta (produced by ABBOT, US) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. Intervention group 3: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Curosurf (produced by chiesi, Italy) at a dose of 4 cc / kg every 6-12 hours until the Fio2 is less than 30%. Improved outcomes in RDS. Timepoint: Before intervention and after intervention. Method of measurement: the need for mechanical ventilation, Venous Blood Gas. Mortality. Timepoint: During the hospital stay. Method of measurement: Dead / alive. Drug-related complications. Timepoint: During the hospital stay. Method of measurement: Yes/No. Iran University of Medical Sciences Approved 2020-01-21 Ethics committee of Iran University of Medical Sciences Hemat Highway, Next to the Milad Tower, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)