Study of role of oral Sildenafil in persistent pulmonary hypertension (PPHN) secondary to Meconium Aspiration Syndrome in newborns

Study of Meconium Aspiration Syndrome (MAS) in Newborns and Role of Oral Sildenafil in Persistent Pulmonary Hypertension (PPHN) Secondary to MAS: A Randomised Placebo Controlled Trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003642

Enrollment

Registered

2013-05-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: P240- Meconium aspiration Health Condition 2: null- Newborns with persistent pulmonary hypertension secondary to meconium aspiration syndrome

Interventions

Intervention1: Tablet Sildenafil: Oral (tablet) Sildenafil 50 mg crushed in distilled water to make a concentration of 5mg/ml through feeding tube, every 6 hourly for a total of 8 doses, dose of 1 mg

Eligibility

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
Improvement in preductal and postductal SpO2 and oxygenation index Timepoint: 2 hours after each dose of Sildenafil	—

Secondary

Measure	Time frame
Morbidity and mortality of patients given oral SildenafilTimepoint: At time of discharge or expiry.	—

Countries

India

Contacts

Public ContactJayendra R Gohil

Government Medical College, Bhavnagar

jayukids@yahoo.com9824090049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026