Sildenafil alone versus Bosentan as an Add-on for treatment of respiratory problem due to persistent fetal circulation among newborns

Sildenafil Monotherapy versus Bosentan as an Add-on for persistent pulmonary hypertension of newborn- an exploratory study - SiMBA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/04/065318

Enrollment

Registered

2024-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-29

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: Bosentan solution: Intervention group: will first receive sildenafil within 30 minutes of enrolment and then followed by the study drug bosentan within another 30 minutes. Bosentan (st

the syringe will be gently shaken before determining the dose. As per the dose @2mg/kg/dose for a particular neonate enrolled, the solution will be aspirated in another 10 ml syringe for dosing. Since

Eligibility

Inclusion criteria

Inclusion criteria: Any intubated neonate more than or equal to 34 w gestational age, within first 7 days of life, having echocardiographic features (given below) along with any one of the following clinical features of PPHN: oxygenation index (OI) greater than 10; fractional of inspired oxygen greater than 0.30; OR labile SpO2 with differential pre- and post-ductal SpO2 greater than 5% (any two of the following echocardiographic parameters: Pulmonary Artery pressure (PAP) more than 30 mmHg PAP means Tricuspid regurgitation (TR) gradient plus RAP (where RAP is right atrial pressure (usually 5-10 mmHg); Bidirectional flow or right to left shunt at PDA, PFO, ASD, or VSD; Ratio of pulmonary artery acceleration time (PAAT) to right ventricular ejection time (RVET): PAAT/RVET less than 0.3; Eccentricity index of LV at end systole more than 1;and Dilated RA and RV. )

Exclusion criteria

Exclusion criteria: Congenital diaphragmatic hernia Major congenital anomalies including structural heart disease except PDA, PFO, VSD or ASD Altered GI aspirates

Design outcomes

Primary

Measure	Time frame
To assess the reduction in oxygenation index (OI) in neonates with PPHN receiving bosentan as an add-on versus sildenafil monotherapy at six hours of initiating treatmentTimepoint: At baseline, after 6 hours of giving intervention drug/placebo	—

Secondary

Measure	Time frame
1. Reduction in OI at 12, 24 h from baseline 2. Reduction in TR at 6, 24 and72 hours from baseline 3. Hemodynamic parameters after the first dose and after 24 h 4. Need for inotropic agent 5. Need for rebound use of vasodilators and/or inotropes 6. Duration of respiratory support and /or mechanical ventilation 7. Incidence of adverse events: gastric Intolerance, transaminitis and bleeding tendencies 8. Time to reach full enteral feeds 9. Co-morbidities IVH, ROP, BPD during hospital stay 10. Mortality in-hospital and until first 28 days of life 11. Duration of NICU and hospital stay Timepoint: During hospital stay and until discharge or death (whichever earlier)	—

Measure

Time frame

1. Reduction in OI at 12, 24 h from baseline 2. Reduction in TR at 6, 24 and72 hours from baseline 3. Hemodynamic parameters after the first dose and after 24 h 4. Need for inotropic agent 5. Need for rebound use of vasodilators and/or inotropes 6. Duration of respiratory support and /or mechanical ventilation 7. Incidence of adverse events: gastric Intolerance, transaminitis and bleeding tendencies 8. Time to reach full enteral feeds 9. Co-morbidities IVH, ROP, BPD during hospital stay 10. Mortality in-hospital and until first 28 days of life 11. Duration of NICU and hospital stay Timepoint: During hospital stay and until discharge or death (whichever earlier)

—

Countries

India

Contacts

Public ContactSUMAN CHAURASIA

AIIMS Rishikesh

drrenupathak77@gmail.com9711325883

Outcome results

None listed

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