Sildenafil alone versus Bosentan as an Add-on for treatment of respiratory problem due to persistent fetal circulation among newborns
- Conditions
- Health Condition 1: P293- Persistent fetal circulation
- Registration Number
- CTRI/2024/04/065318
- Lead Sponsor
- All India Institute of Medical Sciences AIIMS Rishikesh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
)
Congenital diaphragmatic hernia
Major congenital anomalies including structural heart disease except PDA, PFO, VSD or ASD
Altered GI aspirates
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.Reduction in OI at 12, 24 h from baseline <br/ ><br>2.Reduction in TR at 6, 24 and72 hours from baseline <br/ ><br>3.Hemodynamic parameters after the first dose and after 24 h <br/ ><br>4.Need for inotropic agent <br/ ><br>5.Need for rebound use of vasodilators and/or inotropes <br/ ><br>6.Duration of respiratory support and /or mechanical ventilation <br/ ><br>7.Incidence of adverse events: gastric Intolerance, transaminitis and bleeding tendencies <br/ ><br>8.Time to reach full enteral feeds <br/ ><br>9.Co-morbidities IVH, ROP, BPD during hospital stay <br/ ><br>10.Mortality in-hospital and until first 28 days of life <br/ ><br>11.Duration of NICU and hospital stay <br/ ><br>Timepoint: During hospital stay and until discharge or death (whichever earlier)