Hemodynamic profile of neonates with neonatal encephalopathy treated with sildenafil in addition to therapeutic hypothermia
Discuss this preprint
Start a discussion What are Sciety discussions?Listed in
This article is not in any list yet, why not save it to one of your lists.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; p<0.001), decreased pulmonary hypertension markers (p=0.001), and enhanced ventricular strain (p<0.001 for LV; p=0.02 for RV). Inotropic support and lactate levels declined, and cardiac biomarkers improved. Improvements were greatest during TH. Conclusion: Sildenafil was well tolerated and improved cardiovascular function, supporting its potential as an adjunctive therapy in HIE.
