NCT02621944 Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia
| NCT ID | NCT02621944 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Florida |
| Condition | Hypoxic Ischemic Encephalopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2016-11 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 70 participants in total. It began in 2016-11 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Eligible infants are \>36 0/7th weeks gestation, * pH (cord or neonatal) \<7.0, * base deficit \>16 mEq/L, * no available blood gas, * a cord blood/first hour of life blood gas with pH \> 7.0 and \< 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 \< 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. Exclusion Criteria: * suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia, * clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation, * a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.
Contact & Investigator
Michael D Weiss, MD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT02621944 clinical trial?
This trial is open to participants of all sexes, up to 6 Hours, studying Hypoxic Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02621944 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02621944 currently recruiting?
Yes, NCT02621944 is actively recruiting participants. Contact the research team at amcmurra@ufl.edu for enrollment information.
Where is the NCT02621944 trial being conducted?
This trial is being conducted at Gainesville, United States, Orlando, United States.
Who is sponsoring the NCT02621944 clinical trial?
NCT02621944 is sponsored by University of Florida. The principal investigator is Michael D Weiss, MD at University of Florida. The trial plans to enroll 70 participants.