IRCT20260119068615N1 IRCT 2026-02-14 Arak University of Medical Sciences Effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome Comparison effect of oral bosentan in preventing Bronchopulmonary Dysplasia (BPD) in premature infants with respiratory distress syndrome 2026-04-04 anticipated 90 Recruiting https://irct.ir/trial/89002 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization will be used to randomly assign participants. For this purpose, blocks of fixed size (e.g., blocks of 4 or 6) will be considered so that the allocation ratio between the two treatment groups remains balanced throughout the study. The order of allocation within each block will be determined using a random number table (or computer software) and will be placed as coded cards in opaque, impenetrable envelopes. As each eligible infant arrives, one envelope will be opened sequentially and the group allocation will be determined, Blinding description: Patients will not be aware of the type of medication they are receiving. Clinical caregivers will inject the medication prepared in the syringe based on the patient code. Also, the outcome assessor will complete the relevant checklist without knowing the type of intervention. The principal investigator will only be responsible for collecting the checklists and recording the information. 3 Bronchopulmonary Dysplasia. Intervention 1: Intervention group: Oral bosentan plus surfactant (BLES). Intervention 2: Control group: routin treatment surfactant (BLES). 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 No more information available