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IRCT20130812014333N210 IRCT 2023-09-13 Kermanshah University of Medical Sciences A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome A comparative study of the effect of Bractant and Corosurf on the duration of oxygen requirement in premature babies with respiratory distress syndrome with a gestational age of less than 32 weeks 2023-09-21 anticipated 58 Complete https://irct.ir/trial/72484 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization using the blocking method with blocks in sizes 6 and 9. For randomization, the site https://www.sealedenvelope.com is used. All codes are recorded on paper and stored in specific envelopes. Each of the generated codes is kept separately inside the envelope and the secretary gives one of these envelopes to the patient before the patient enters the doctor's room. Accordingly, the next patient code is not predictable. The doctor determines which treatments to perform based on the patient's code. Only the physician performing the intervention will be aware of the code assigned to the patient. After evaluating the outcome, based on the patient's name, the collected information will be linked to the assigned code, Blinding description: Medications can only be identified by the serial number on the container. The serials are with the main researcher and will remain confidential until the end of the study. The charge of injecting medications will not know about the assignment of individuals to groups. N/A Distress syndrome of neonates. Intervention 1: In the first intervention group, in the first 12 hours after birth, they will receive the manufactured Berketant surfactant (manufactured byTekzima, Iran), an 8cc vial prepared from pig lungs. Intervention 2: The second intervention group will receive Corosurf surfactant (manufactured by Cheisi, Italy) in a 3 cc vial prepared from pig lungs in the first 12 hours after birth. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Maryam Reza Beigi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 maryamrezabeigi1358@gmail.com Kermanshah University of Medical Sciences scientific Dr. Noushin Miladi
Emam Reza Hospital, Parastar Boulevard
Kermanshah Iran (Islamic Republic of) 6715847141 +98 83 3427 6306 maryamrezabeigi1358@gmail.com Kermanshah University of Medical Sciences Iran (Islamic Republic of) Premature babies less than 32 weeks with respiratory distress syndrome Infants who need surfactant 1 day 30 days Both Existence of other respiratory diseases other than respiratory distress syndrome Congenital heart abnormalities A history of resuscitation at birth with severe metabolic vasculitis P22.0 Respiratory distress syndrome of newborn Treatment - Drugs Treatment - Drugs In the first intervention group, in the first 12 hours after birth, they will receive the manufactured Berketant surfactant (manufactured byTekzima, Iran), an 8cc vial prepared from pig lungs The second intervention group will receive Corosurf surfactant (manufactured by Cheisi, Italy) in a 3 cc vial prepared from pig lungs in the first 12 hours after birth. Duration of NICU stay. Timepoint: End of study. Method of measurement: Based on the hospitalization record. Kermanshah University of Medical Sciences Approved 2023-05-13 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard Kermanshah Kermanshah Iran (Islamic Republic of)