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Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia — SANE-02  

Birth Asphyxia Clinical Trial

Official title:
Treatment of Neonatal Encephalopathy With Oral Sildenafil Suspension to Repair Brain Injury Secondary to Birth Asphyxia: An Open-label Dose-finding Clinical Trial (Phase Ib Study)

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04169191
Study type Interventional
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 19, 2019
Completion date June 2024
View Details
See also
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