Melatonin as a neuroprotective therapy in neonates with HIE undergoing hypothermia
BACKGROUND: A significant number of babies with hypoxic-ischemic encephalopathy (HIE) have permanent lifelong neurodevelopmental handicaps in the form of cerebral palsy (CP), mental retardation, learning disabilities, or epilepsy.
GAP: The evidence regarding melatonin as a safe neuroprotective therapy is impressive; however, the safety and dosing of enteral melatonin in infants with HI undergoing hypothermia has not been examined. This project will examine the safety and dosing of enteral melatonin in infants with HI undergoing hypothermia.
HYPOTHESIS: We hypothesize that enteral melatonin will be safe at each dose tested in neonates with HIE undergoing hypothermia.
METHODS: The phase 0/1 study will examine the pharmacodynamics, pharmacokinetics, and safety and effectiveness of enterally administered melatonin in reducing oxidative stress and the inflammatory cascade in neonates undergoing hypothermia. In addition, outcomes at 18-22 months will be performed.
IMPACT: The data will be used as pilot data for a multicenter trial that will examine the use of enteral melatonin in combination with hypothermia to improve neurologic outcomes. The study will be carried out in the Florida Neonatal Neurologic Network, which the PI founded.
Drug Therapy, Human, Neonatal, Treatment