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Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

NCT02621944 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-10-02

No results posted yet for this study

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.

Conditions

  • Hypoxic Ischemic Encephalopathy

Interventions

DRUG

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.

OTHER

Magnetic Resonance Imaging

All participants will receive an MRI between 7-12 days of age.

OTHER

Pharmacokinetics

All participants will receive pharmacokinetics to test the amount of melatonin in the blood.

BEHAVIORAL

Neurological Outcome Assessment

All participants will receive the Bayley-III Scores and Subsets for neurological outcome assessments.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Michael D Weiss, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02621944 on ClinicalTrials.gov