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IRCT20160120026115N9 IRCT 2022-12-03 Iran University of Medical Sciences The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil 2020-12-30 anticipated 60 Complete https://irct.ir/trial/64913 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done according to the random number table using the RAND function in Excel software. The even numbers obtained in this table were assigned to drug A (Bosentan and Sildenafil) and the odd numbers to drug B (Masitentan and Sildenafil). The random list was given to the epidemiologist of the study, and each patient who entered the study was contacted by the doctor to find out whether the person entered group A or B, Blinding description: The drugs received are identical in appearance (color and size), the pills were placed in coded envelopes with the same appearance, and the patient and cardiologist did not know about the drug received. 3 Persistent pulmonary hypertension of the newborn. Intervention 1: Intervention group: Bosentan tablets (manufactured by Faran Shimi, Iran) with a concentration of 1 mg/kg and Sildenafil (Alborz Darou) with a concentration of 0.4 mg /kg every 12 hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30. Intervention 2: Intervention group: Macitentan tablets (Tadbir Kalaye Jam) with a concentration of 1 mg/kg and Sildenafil(Alborz Darou) with a concentration of 1 mg/kg every twelve hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30. Yes - There is a plan to make this available What will be shared: Avalable Information When: 1402 To whom: All of peaple Conditions: Information Where to obtain: Email S.dabbagh69@yahoo.com How to obtain: Asked from email Comments:
public Sama dabbagh
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Tehran Iran (Islamic Republic of) 1449614535 +98 21 8843 0783 S.dabbagh69@yahoo.com Iran University of Medical Sciences scientific Mandana Kashaki
Molavi (cross), Molavi St
Tehran Iran (Islamic Republic of) 1168743514 +98 21 5560 6034 kashakimd@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Parents' satisfaction to participate in the study Newborns with respiratory symptoms, decreased arterial oxygen saturation, and cyanosis Pulmonary artery pressure greater than or equal to 25 mmHg and severity of tricuspid valve failure greater than or equal to 30 mmHg with or without right-to-left shunt 1 day 1 month Both Cyanotic heart diseases Other diseases cyanosis Increased pulmonary artery pressure due to pneumonia or meconium aspiration P29.3 Persistent fetal circulation Treatment - Drugs Treatment - Drugs Intervention group: Bosentan tablets (manufactured by Faran Shimi, Iran) with a concentration of 1 mg/kg and Sildenafil (Alborz Darou) with a concentration of 0.4 mg /kg every 12 hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30. Intervention group: Macitentan tablets (Tadbir Kalaye Jam) with a concentration of 1 mg/kg and Sildenafil(Alborz Darou) with a concentration of 1 mg/kg every twelve hours were prescribed. The treatment was discontinued when the arterial oxygen saturation level was higher than 95 and the Pulmonary Arterial Hypertension was lower than 25 in echocardiography and the severity of Tricuspid valve regurgitation was lower than 30. Persistent Pulmonary Hypertension of the Newborn. Timepoint: The beginning of the study, 6 and 12 days after the intervention. Method of measurement: Echocardiography. Iran University of Medical Sciences Approved 2021-06-12 Ethics committee of Iran University of Medical Sciences Next to the Milad Tower, Hemat Highway. Tehran Tehran Iran (Islamic Republic of)