Pia Wintermark, Anie Lapointe, Robin Steinhorn, Emmanouil Rampakakis, Jürgen Burhenne, Andreas D Meid, Gzona Bajraktari-Sylejmani, May Khairy, Gabriel Altit, Marie-Therese Adamo, Alishia Poccia, Guillaume Gilbert, Christine Saint-Martin, Daniela Toffoli, Julie Vachon, Elizabeth Hailu, Patrick Colin, Walter E Haefeli
OBJECTIVE: To test feasibility and safety of administering sildenafil in neonates with neonatal encephalopathy (NE), developing brain injury despite therapeutic hypothermia (TH). STUDY DESIGN: We performed a randomized, double-blind, placebo-controlled phase Ib clinical trial between 2016 and 2019 in neonates with moderate or severe NE, displaying brain injury on day of life 2 magnetic resonance imaging (MRI) despite TH. Neonates were randomized (2:1) to 7-day sildenafil or placebo (2 mg/kg/dose enterally q12h, 14 doses)...
December 21, 2023: Journal of Pediatrics