comparative efficacy of sildenafil and bosentan in newborn with persistent pulmonary hypertensio

Phase 1

Recruiting

• Conditions: Persistent pulmonary hypertension; PPHN; PPH

• Registration Number: TCTR20230816006
• Lead Sponsor: self

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Study Completion: 2024-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

1. less than 10 days of age of either gender greater than 34 weeks of gestational age
echocardiographic findings according to operational definations
2. new born with sign and symptoms of PPHN not related to any secondary cause

Exclusion Criteria

1. babies with congenital heart disease except atrieal septal defect
other cyanosis diseases and PPHN caused by pneumonia or meconium aspiration
ventriculo septal defect
2. babies with active seiures pneumothorax and other congenital anomalies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
drug efficacy 1 year tricuspid regurgitation jet pressure from echo

Secondary Outcome Measures

Name	Time	Method
drug capability 1 year oxygen dependency