Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia
Status:
Recruiting
Trial end date:
2024-08-01
Target enrollment:
Participant gender:
Summary
The investigators will determine the maximum tolerable dose of sildenafil and establish the
pharmacokinetic and pharmacodynamic profile of sildenafil in human asphyxiated neonates
treated with hypothermia. They will use a 3+3 design to escalate the sildenafil dose up to 6
mg/kg/day (3mg/kg/dose q12h) in asphyxiated neonates demonstrating brain injury despite
hypothermia treatment and assess whether we observe any beneficial effects of sildenafil on
their brain and cardiopulmonary hemodynamics, without causing serious adverse events
Phase:
Phase 1
Details
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre Pia Wintermark