This clinical trial focuses on infantile spasm syndrome, a serious condition that can affect children under one year of age. The study specifically looks at children who are at high risk of developing this condition, including those with tuberous sclerosis (a rare genetic disorder) or those who have experienced significant brain injuries such as large blood vessel damage, severe brain bleeds, or infections affecting the brain tissue.
The study uses vigabatrin, which is given as granules that are mixed with liquid and taken by mouth. This medication will be given as a preventive treatment before any signs of infantile spasms appear. The maximum daily dose is 150 milligrams per kilogram of body weight, and the treatment can continue for up to 11 months.
The main goal of this research is to determine if giving vigabatrin early to high-risk infants can prevent the development of infantile spasm syndrome. The study also looks at how the children’s brain development progresses and uses special eye tracking methods to monitor their development. MRI scans of the brain, which have been performed as part of regular medical care, are used to identify children who might benefit from participating in this research.
Finland 
