RECRUITING

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Quick Facts

Study Start:2016-11
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02621944

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.

Ages Eligible for Study:Not specified to 6 Hours
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Eligible infants are \>36 0/7th weeks gestation,
  2. * pH (cord or neonatal) \<7.0,
  3. * base deficit \>16 mEq/L,
  4. * no available blood gas,
  5. * a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
  6. * base deficit between 10 and 15.9 mEq/L,
  7. * infants must have a history of an acute perinatal event,
  8. * either a 10-minute Apgar \< 5 or a continued need for ventilation,
  9. * All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
  10. * neonates cooled within 6 hours of birth will be included in the study.
  1. * suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
  2. * clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
  3. * a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.

Contacts and Locations

Study Contact

Shaveka Gaskins, MBBS, Bsc
CONTACT
3522738706
gaskins.shaveka@ufl.edu
Kristine Boykin, BSN
CONTACT
3522738706
kristineboykin@ufl.edu

Principal Investigator

Michael D Weiss, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32610
United States
Florida Hospital for Children
Orlando, Florida, 32803
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Michael D Weiss, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11
Study Completion Date2026-03

Study Record Updates

Study Start Date2016-11
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • Hypoxic Ischemic Encephalopathy