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To compare oral Sildenafil and Bosentan in the treatment of pulmonary hypertension in neonates

Comparison of oral Sildenafil and Bosentan in the treatment of persistent pulmonary arterial hypertension in neonates

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043328
Enrollment
98
Registered
2022-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2022-06-27

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

Conditions

Health Condition 1: P293- Persistent fetal circulation

Interventions

Intervention1: Oral sildenafil in management of pphn.: â?¢Babies randomised into oral sildenafil group will be given 2 mg/kg per dose every 6th hourly. Oral tablet of Sildenafil of strength 20 mg will

Sponsors

Department of Neonatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonates with 34 weeks of completed gestational age who are echocardiographically diagnosed to have Persistent pulmonary hypertension of the newborn defined as 1.PASP of more than 35 mm of Hg calculation by TR peak jet velocity and Fio2 requirement > 21%

Exclusion criteria

Exclusion criteria: 1. Congenital heart disease (Except patent ductus arteriosus, atrial septal defect ( 2. Congenital diaphragmatic hernia 3. Lethal congenital anomaly 4. Babies with severe PPHN with Oxygenation index (OI) > 15 and directly started on inhaled nitric oxide (iNO) on diagnosis.

Design outcomes

Primary

MeasureTime frame
To compare the time taken for pulmonary artery systolic pressure (PASP) to decrease below 30 mm Hg among neonates diagnosed with PPHN receiving oral sildenafil as compared to those receiving oral bosentan.Timepoint: 1 month

Secondary

MeasureTime frame
To compare oral sildenafil and bosentan in neonates with PPHN in terms of â?¢Duration of ventilation â?? both invasive, non-invasive and nasal oxygen â?¢Duration of hospital stay â?¢Time taken to reach room air â?¢Failure rates â?¢Mortality â?¢To compare the time to achieve full feeds in both groups Timepoint: 1 month

Countries

India

Contacts

Public ContactShreya S Nandikol

Bharati Vidyapeeth University

drpradeepsuryawanshi@gmail.com7207731374

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026