Grant: Project Grant

Around the time of birth, some babies experience asphyxia, a condition where their brain (hypoxic-ischemic encephalopathy, HIE) and organs do not get enough oxygen and/or blood to function properly. This life-threatening condition is responsible for nearly 25% of babies' deaths worldwide. Babies who survive are often left with serious issues, such as brain damage, cerebral palsy, epilepsy, and difficulties with learning and daily functioning. Currently, there are no treatments to repair brain damage caused by birth asphyxia. However, a drug called sildenafil (Viagra®) may offer a new solution. In our laboratory, we developed a model of birth asphyxia and discovered that sildenafil could help repair brain damage caused by birth asphyxia. Our 2 recent small studies conducted in one hospital showed that giving sildenafil to babies with HIE was both feasible and safe. These studies also identified the maximum safe dose of sildenafil for babies with HIE and showed encouraging signs that sildenafil may reduce brain damage and improve outcomes. Now, it is time to test this promising treatment on a larger group of babies with HIE. This project will test whether it is feasible and safe to assign by chance sildenafil or placebo to babies with HIE in 5 hospitals across Canada. To prove whether it is feasible, we will track how many parents agree to enroll their babies in the study. To evaluate whether it is safe, we will monitor side effects and perform cardiac ultrasounds before and after treatment. To see how well the treatment works, we will track the number of deaths, compare brain imaging before and after treatment, and assess the babies' development over time. This project will help determine whether sildenafil could be a promising treatment to repair brain damage in babies HIE and improve their future life. If successful, our research could benefit many families in Canada and around the world, who are impacted by this devastating condition.