Clinical Research Directory
Browse clinical research sites, groups, and studies.
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Sponsor: University of Florida
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.
Key Details
Gender
All
Age Range
Any - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2016-11
Completion Date
2026-03
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Melatonin
Participants 1-10 will receive a 0.5 mg/kg enteral dose of Melatonin. Participants 11-20 will receive Melatonin dose of 3 mg/kg enteral. Participants 21-30 will receive Melatonin dose of 5 mg/kg enterally.
Magnetic Resonance Imaging
All participants will receive an MRI between 7-12 days of age.
Pharmacokinetics
All participants will receive pharmacokinetics to test the amount of melatonin in the blood.
Neurological Outcome Assessment
All participants will receive the Bayley-III Scores and Subsets for neurological outcome assessments.
Locations (2)
University of Florida
Gainesville, Florida, United States
Florida Hospital for Children
Orlando, Florida, United States