Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
Participant gender:
Summary
Hypoxic-Ischemic Encephalopathy (HIE) occurs in 20 per 1000 births. Only 47% of neonates
treated with the state of the art therapy (induced systemic hypothermia) have normal
outcomes. Therefore, other promising therapies that potentially work in synergy with
hypothermia to improve neurologic outcomes need to be tested. One potential agent is
melatonin. Melatonin is a naturally occurring substance produced mainly from the pineal
gland. Melatonin is widely known for its role in regulating the circadian rhythm, but it has
many other effects that may benefit infants with HI injury. Melatonin serves as a free
radical scavenger, decreases inflammatory cytokines, and stimulates anti-oxidant enzymes.
Therefore, melatonin may interrupt several key components in the pathophysiology of HIE, in
turn minimizing cell death and improving outcomes. The research study will evaluate the
neuroprotective properties and appropriate dose of Melatonin to give to infants undergoing
therapeutic hypothermia for hypoxic ischemic encephalopathy.