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.
Age range
6 Hours
Sex
ALL
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To identify the maximum tolerated dose of Melatonin
Timeframe: Changes in Baseline to day 3
Bayley-III Index Scores (Cognitive, Language, and Motor) will be used for neurological outcome assessment
Timeframe: Approximately 18 - 20 Months
Peak Plasma Concentration (Cmax) of Melatonin 0.5 mg/kg.
Timeframe: 0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)
Number of participants with treatment-related adverse events as assessed by MedDRA ??? This is something the PI/Team needs to agree on which one to use.
Timeframe: Baseline ongoing to Day 14
Peak Plasma Concentration (Cmax) of Melatonin 3 mg/kg.
Timeframe: 0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)
Peak Plasma Concentration (Cmax) of Melatonin 5 mg/kg.
Timeframe: 0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)