U.S., Feb. 6 -- ClinicalTrials.gov registry received information related to the study (NCT06810284) titled 'Sildenafil Plus Hypothermia to Treat Neonatal Encephalopathy' on Sept. 24, 2024.
Brief Summary: The main objective of this study is to assess pharmacokinetics features of IV sildenafil in neonates with hypoxic-ischemic encephalopathy and treated by controlled hypothermia. This phase 2 study will prepare a large phase 3 randomized controlled trial to demonstrate the superiority of a combinatory therapy associating IV sildenafil and controlled hypothermia compared to Placebo and controlled hypothermia, on survival without brain lesions on MRI at discharge, in neonates born after 36 weeks of gestation.
Study Start Date: July, 2025
Stu...