Actively Recruiting
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Led by University of Florida · Updated on 2025-10-02
70
Participants Needed
2
Research Sites
486 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
T
Thrasher Research Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eligible infants are more than 36 0/7 weeks gestation
- pH (cord or neonatal) less than 7.0
- Base deficit greater than 16 mEq/L
- If no blood gas available, cord blood or first hour blood gas with pH greater than 7.0 and less than 7.15
- Base deficit between 10 and 15.9 mEq/L
- Infants must have a history of an acute perinatal event
- Either a 10-minute Apgar score less than 5 or a continued need for ventilation
- All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system
- Neonates cooled within 6 hours of birth will be included in the study
You will not qualify if you...
- Suspected inborn errors of metabolism such as elevated ammonia and hypoglycemia
- Clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation
- Diagnosis of congenital abdominal surgical problems with multiple congenital anomalies and/or chromosomal abnormalities
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
2
Florida Hospital for Children
Orlando, Florida, United States, 32803
Actively Recruiting
Research Team
A
Alison A McMurray, M.A.M.C.
CONTACT
K
Kristine Boykin, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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