Condition: Hypoxic Ischemic Encephalopathy · Sponsor: University of Florida
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.
This description comes directly from the study's public registry record.
Alison A McMurray, M.A.M.C. · 3526275016 · amcmurra@ufl.edu
Kristine Boykin, BSN · 3522738706 · kristineboykin@ufl.edu
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| University of Florida | Gainesville, Florida, United States | Recruiting |
| Florida Hospital for Children | Orlando, Florida, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT02621944