Vigabatrin is a medication used to treat and prevent seizures. In this trial, it is being used preventively in infants who are at high risk of developing infantile spasms. The medication works by increasing the levels of a natural calming substance in the brain called GABA. It is particularly effective in treating infantile spasms, especially in children with a condition called tuberous sclerosis. The medication comes in a form that can be given to infants and young children.

Infantile Spasm Syndrome – A rare epileptic disorder that typically begins in the first year of life, characterized by sudden, brief stiffening of the body, arms, and legs. The spasms tend to occur in clusters and are most common in the morning or after naps. This condition can affect brain development and is often associated with underlying brain conditions.

Tuberous Sclerosis – A genetic disorder that causes non-cancerous tumors to grow in various parts of the body, particularly the brain, kidneys, heart, lungs, and skin. The condition typically becomes apparent in early childhood. It can cause patches on the skin, seizures, and developmental issues. The severity and symptoms vary widely among affected individuals.

Hypoxic-Ischemic Encephalopathy (HIE) – A type of brain dysfunction that occurs when the brain doesn’t receive enough oxygen or blood flow. It can affect various areas of the brain and may lead to developmental challenges. The condition develops shortly after birth and can vary in severity.

Periventricular Leukomalacia (PVL) – A type of brain injury that affects white matter in the brain, most commonly seen in premature infants. The condition involves the death of small areas of brain tissue around the fluid-filled ventricles. It can affect the transmission of nerve signals in the brain.