The effect of Macitentan compared to Bosentan in neonates with persistent pulmonary hypertension treated with Sildenafil

Phase 3

• Conditions: Persistent pulmonary hypertension of the newborn.; Persistent fetal circulation; P29.3

• Registration Number: IRCT20160120026115N9
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

Cyanotic heart diseases
Other diseases cyanosis
Increased pulmonary artery pressure due to pneumonia or meconium aspiration

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Persistent Pulmonary Hypertension of the Newborn. Timepoint: The beginning of the study, 6 and 12 days after the intervention. Method of measurement: Echocardiography.