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NCT02621944 · ClinicalTrials.gov registry record · Early Phase 1

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

A Early Phase 1 study of Hypoxic Ischemic Encephalopathy, sponsored by University of Florida.

Recruiting
Registry status
Early Phase 1
Development phase
70
Enrollment target
2
Study locations

NCT02621944 is a Early Phase 1 study of Hypoxic Ischemic Encephalopathy that is actively recruiting participants, run by University of Florida. The registered enrollment target is 70 participants, below the 78-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (10% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT02621944, a Early Phase 1 study of Hypoxic Ischemic Encephalopathy, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
Early Phase 1
Development phase
70 participants
Enrollment target
2
Study locations

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 Studied

Hypoxic Ischemic Encephalopathy

Interventions

  • DRUG Melatonin
  • OTHER Magnetic Resonance Imaging
  • OTHER Pharmacokinetics
  • BEHAVIORAL Neurological Outcome Assessment

Study Locations (2)

Florida

  • University of Florida - Gainesville
  • Florida Hospital for Children - Orlando

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2016-11
Est. Completion 2026-03
Phase Early Phase 1

Sponsor

University of Florida

1,106 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02621944

The ClinicalTrials.gov registry entry for NCT02621944 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 78-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (10% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypoxic Ischemic Encephalopathy appearing as the primary indexed condition, and to 4 interventions - of which Melatonin is the first listed.

NCT02621944 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT02621944 about?

NCT02621944 is a clinical study titled "Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia". 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 outcome...

What is the current status of trial NCT02621944?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2016-11. Estimated completion is 2026-03.

What conditions does trial NCT02621944 study?

This clinical trial studies the following conditions: Hypoxic Ischemic Encephalopathy.

What interventions are being tested in trial NCT02621944?

The interventions under investigation include: Melatonin (DRUG), Magnetic Resonance Imaging (OTHER), Pharmacokinetics (OTHER), Neurological Outcome Assessment (BEHAVIORAL).

Who is sponsoring clinical trial NCT02621944?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02621944 being conducted?

This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.