Study of a medicine called sildenafil to see how good it is to decrease persistent pressure in vessels of heart supplying lung after birth in newborns selected randomly
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Term newborns with persistent pulmonary hypertension
- Registration Number
- CTRI/2015/05/005797
- Lead Sponsor
- Vivekananda Institute Of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
term newborns diagnosed to have persistent pulmonary hypertension on the basis of clinical and echocardiographic criteria .
Exclusion Criteria
1.Preterm with RDS
2.Surgical cases like congenital diaphragmatic hernia
3.Major congenital anomaly including congenital heart disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Improvement in DOWNEâ??S score <br/ ><br>2.Improvement in oxygenation index in ventilated babies and oxygen requirement in nonventilated babies <br/ ><br>3.Echo criteria-decrease in peak pulmonary pressure in terms of tricuspid regurgitation gradient <br/ ><br>Timepoint: 1.Improvement in DOWNEâ??S score by day 5 of start of therapy <br/ ><br>2.Improvement in oxygenation index in ventilated babies and oxygen requirement in nonventilated babies by day 5 of start of therapy <br/ ><br>3.Echo criteria-decrease in peak pulmonary pressure in terms of tricuspid regurgitation gradient by day 5 of start of therapy <br/ ><br>
- Secondary Outcome Measures
Name Time Method Adverse effects of sildenafil like hypotension,hyperthermiaTimepoint: Two years