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To compare between IV and oral preparations of sildenafil in persistent pulmonary hypertension of newborn

Oral vs IV sildenafil in persistent pulmonary hypertension of newborn (PPHN) : A randomized controlled pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018781
Enrollment
40
Registered
2019-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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, IV sildenafil: To compare between Oral sildenafil and IV sildenafil in persistent pulmonary hypertension of newborn Intervention2: IV sildenafil: ROUTE - IV DOSE - load

Sponsors

Bharati Hospital
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Congenital heart disease (Except patent ductus arteriosus, patent foramen ovale, atrial septal defect, or a single, small muscular ( 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

Design outcomes

Primary

MeasureTime frame
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—

Secondary

MeasureTime frame
Compare Time taken for Oxygenation index (OI)to decrease by 25%; Duration of mechanical ventilation ââ?¬â?? both invasive (intubated days), and non-invasive; Duration of hospital stay; Mortality; Improvement in echocardiological findings; To compare the side effects of IV and Oral sildenafil; To compare the time to achieve full feeds in both groups Timepoint: 12 hrly—

Countries

India

Contacts

Public ContactChinmay Chetan

Bharati Vidyapeeth Deemed University

drpradeepsuryawanshi@gmail.com9923540500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 12, 2026