Sildenafil Administration to Treat Neonatal Encephalopathy
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Despite improvements in neonatal care, birth asphyxia in term newborns remains a serious
condition causing significant mortality and long-term morbidity, including cerebral palsy and
mental retardation. Currently, no treatment exists to repair brain injuries secondary to
neonatal asphyxia. The only available treatment for this condition is hypothermia that may
prevent but not repair the development of brain injury. The success of this therapy is
limited.
Sildenafil already is used with some newborns for other purposes (i.e., persistent pulmonary
hypertension), but, surprisingly, its effect on the newborn brain has never been studied
systematically. The findings of the investigators in the rat model of term neonatal
encephalopathy demonstrated that the administration of sildenafil following asphyxia promotes
brain injury recovery. Thus, the investigators hypothesize that sildenafil may improve
neurodevelopmental outcome in term asphyxiated newborns, in whom hypothermia treatment has
failed to prevent the development of brain injury.
Phase:
Phase 1
Details
Lead Sponsor:
McGill University Health Center McGill University Health Centre/Research Institute of the McGill University Health Centre