Feasibility and safety of sildenafil to repair brain injury secondary to birth asphyxia (SANE-01): A randomized, double-blind, placebo-controlled phase Ib clinical trial

CONCLUSIONS: Sildenafil was safe and well absorbed in neonates with NE treated with TH. Optimal dosing needs to be established. Evaluation of a larger number of neonates through subsequent phases II and III trials will then be required to establish …