Melatonin in Ethanol clinical trials

ACUMEN: Phase I Dose Escalation and Cohort Expansion study to affirm the safety of pharmacological doses of a novel formulation of intravenous melatonin in babies with hypoxic-ischaemic encephalopathy (HIE) to augment therapeutic hypothermia (HT) treatment; to reduce the incidence and severity of disability in babies with moderate-severe HIE.

This study looks at a new melatonin treatment for babies with a brain injury called HIE. We want to check if it's safe at different doses and if it helps reduce long-term problems when combined with cooling treatment. It's the first step to see if this treatment could help babies.