To compare between IV and oral preparations of sildenafil in persistent pulmonary hypertension of newbor
Not Applicable
Completed
- Conditions
- Health Condition 1: P293- Persistent fetal circulation
- Registration Number
- CTRI/2019/04/018781
- Lead Sponsor
- Bharati Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Late preterm and term neonates who are echocardiographicaly diagnosed to have PPHN (defined as PAP of more than 25 millimetre of mercury (mm Hg)),
PPHN diagnosed within 72 hrs of life
Exclusion Criteria
Congenital heart disease (Except patent ductus arteriosus, patent foramen ovale, atrial septal defect, or a single, small muscular ( <4 mm) ventricular septal defect);
Contraindication to oral/IV sildenafil ââ?¬â?? systemic hypotension, necrotizing enterocolitis (NEC), Gastrointestinal bleed;
Congenital diaphragmatic hernia;
Lethal congenital anomaly;
Babies with severe PPHN directly started on nitric oxide on diagnosis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the time to adequate clinical response to oral and IV sildenafil in neonates diagnosed with PPHN in terms of time taken for pulmonary artery pressure (PAP) to decrease below 25 mm HgTimepoint: Every 12 hours <br/ ><br>
- Secondary Outcome Measures
Name Time Method Compare <br/ ><br>Time taken for Oxygenation index (OI)to decrease by 25%; <br/ ><br>Duration of mechanical ventilation ââ?¬â?? both invasive (intubated days), and non-invasive; <br/ ><br>Duration of hospital stay; <br/ ><br>Mortality; <br/ ><br>Improvement in echocardiological findings; <br/ ><br>To compare the side effects of IV and Oral sildenafil; <br/ ><br>To compare the time to achieve full feeds in both groups <br/ ><br>Timepoint: 12 hrly