Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

The maximum tolerated dose (MTD) is defined as the highest dose level without adverse events in no more than 1 out of 6 patients

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
University of Florida

1,106 total trials

What NCT02621944 shows while recruiting

NCT02621944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 78-participant average among 13 other Hypoxic Ischemic Encephalopathy trials with a reported enrollment target (10% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Hypoxic Ischemic Encephalopathy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02621944's enrollment target sits among peer trials

70 5th of 13 higher than 9 of 13 other Hypoxic Ischemic Encephalopathy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hypoxic Ischemic Encephalopathy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00969111 · 70 participants · NA

    Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy

  • NCT01712620 · 70 participants · Phase 2

    Spironolactone for Pulmonary Arterial Hypertension

  • NCT02143830 · 70 participants · Phase 2

    HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy

  • NCT02601339 · 70 participants

    NIRS Monitoring in Premature Infants

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

More recruiting context for NCT02621944

Source: ClinicalTrials.gov NCT02621944, the US trial registry maintained by the National Library of Medicine. NCT02621944 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.