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

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

Status
Unknown
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230816006
Enrollment
84
Registered
2023-08-16
Start date
2023-01-16
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent pulmonary hypertension PPHN

Interventions

subject will be given sildenafil and its efficacy will be studied over 3 days,subject will be given bosentan and its efficacy will be studied over 3 days
Active Comparator Drug,Active Comparator Drug

Sponsors

self
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 10 Days

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
drug efficacy 1 year tricuspid regurgitation jet pressure from echo

Secondary

MeasureTime frame
drug capability 1 year oxygen dependency

Countries

Pakistan

Contacts

Public Contactabdul chtha

Children's hospital ,Lahore

drabdulqayyumchtha@gmail.com03213194995

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026