Oral versus intravenous sildenafil for pulmonary hypertension in neonates: a randomized trial.

Summary

Open-label randomised trial from a tertiary NICU in western India comparing oral versus intravenous sildenafil in 40 neonates born after 34 weeks with echocardiographically confirmed mild to moderate pulmonary hypertension within 72 hours of birth. The primary outcome was time for pulmonary arterial pressure to fall below the study threshold, with secondary outcomes including oxygenation index, respiratory support duration, feeding, hospital stay, mortality and adverse effects. Efficacy was similar between routes, but systemic hypotension occurred only in the intravenous group. Particularly relevant to settings where inhaled nitric oxide is unavailable.

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