Comparison of Bosentan and Sildenafil in the treatment of persistent pulmonary hypertension of the newbor

Phase 2

• Conditions: Persistent pulmonary hypertension of newborn.; Persistent pulmonary hypertension; I26-28

• Registration Number: IRCT20190127042504N1
• 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: 25 February 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

All new borns with respiratory distress, decreased of Sat o2 and cyanossies admitted to the NICU of Akbarabadi and Ali Asghar hospital
If the echocardiography findings are based on pulmonary artery pressure higher than or equal to 25 mmHg
The severity of tricuspid valve regurgitation higher than or equal to 30 mmHg with or without right to left shunt
Obtaining the consent of the parents

Exclusion Criteria

Other cyanotic heart disease
No other cyanotic justifying disease
PPHN is not due to pneumonia or meconium aspiration

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary artery pressure. Timepoint: At the start of study and then 1week after. Method of measurement: Echocardiography.

Secondary Outcome Measures

Name	Time	Method
Comparison of the duration of treatment in the two groups. Timepoint: daily visit. Method of measurement: Physical examination.;Comparison of the duration of O2 as needed in two groups. Timepoint: Daily visit. Method of measurement: Pulseoximetery.;Comparrison of side effect in 2 groups. Timepoint: Daily visit,weekly labratory test. Method of measurement: Blood pressure,labratory.