Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Description

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

Hypoxic Ischemic Encephalopathy

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Study Overview

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Study Details

Study overview

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.

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Condition
Hypoxic Ischemic Encephalopathy
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Orlando

Florida Hospital for Children, Orlando, Florida, United States, 32803

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

to 6 Hours

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Florida,

Michael D Weiss, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2026-03