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Hemodynamic profile of neonates with neonatal encephalopathy treated with sildenafil in addition to therapeutic hypothermia

Lapointe A, Wintermark P, Rampakakis E, Moore S, Wutthigate P, Simoneau J, Altit G

2025

20 participants

Abstract

Abstract Objective: To evaluate sildenafil’s effects on cardiac function and hemodynamic stability in neonates with moderate-to-severe hypoxic-ischemic encephalopathy (HIE) treated with therapeutic hypothermia (TH). Study Design: Two phase Ib trials (SANE-01/02; NCT02812433, NCT04169191) enrolled neonates with MRI-confirmed brain injury receiving sildenafil (n=20) or placebo (n=4) enterally (2.0–3.0 mg/kg q12h × 14 doses). Targeted echocardiography, speckle-tracking, and biomarkers were measured on days 2–10. Results: Sildenafil improved left and right ventricular outputs (p=0.02; pConclusion: Sildenafil was well tolerated and improved cardiovascular function, supporting its potential as an adjunctive therapy in HIE.

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