Study of role of oral Sildenafil in persistent pulmonary hypertension (PPHN) secondary to Meconium Aspiration Syndrome in newborns
Phase 4
- Conditions
- Health Condition 1: P240- Meconium aspirationHealth Condition 2: null- Newborns with persistent pulmonary hypertension secondary to meconium aspiration syndrome
- Registration Number
- CTRI/2013/05/003642
- Lead Sponsor
- Govt Medical collegeBhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Gestational age at delivery > 34 weeks (newborns)
Babies admitted with meconium stained amniotic fluid or staining of umbilical cord, nails or skin.
All newborns with MAS diagnosed with PPHN admitted within 12 hours of delivery.
Exclusion Criteria
Babies with congenital anomalies incompatible to life and congenital heart disease.
Respiratory morbidities like hyaline membrane disease, congenital pneumonia
Babies with PPHN secondary to MAS admitted after 12 hours of delivery
Babies deteriorating after 2 doses of Sildenafil requiring magnesium sulphate or alkalinisation (pH >7.5)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in preductal and postductal SpO2 and oxygenation indexTimepoint: 2 hours after each dose of Sildenafil
- Secondary Outcome Measures
Name Time Method Morbidity and mortality of patients given oral SildenafilTimepoint: At time of discharge or expiry.