Melatonin – A hormone naturally produced in the body that helps regulate sleep-wake cycles. In this trial, it is being tested in a new intravenous formulation to help protect the brain in newborn babies who have experienced oxygen deprivation during birth (hypoxic-ischaemic encephalopathy). The medication is being studied alongside therapeutic hypothermia (cooling treatment) to potentially reduce brain damage and disability in these infants.

Therapeutic Hypothermia – A medical treatment that involves carefully cooling a baby’s body temperature. This cooling therapy is the current standard treatment for newborns who have experienced oxygen deprivation at birth. It helps reduce brain injury and improve outcomes for these babies.

Hypoxic-Ischemic Encephalopathy (HIE) – A brain injury that occurs when the brain doesn’t receive enough oxygen and blood flow. This condition typically develops during or near the time of birth when something disrupts the normal flow of oxygen to a baby’s brain. The reduced oxygen and blood flow causes damage to brain tissue, which can affect various areas of brain function. The condition can vary in severity from mild to severe, with different levels of impact on brain function. HIE can affect multiple areas of the brain, including those responsible for movement, learning, and development. The initial phase of injury is followed by a complex cascade of events in the brain tissue that can continue for several hours or days.