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Melatonin for Neonatal Hypoxic-Ischemic Encephalopathy

Phase < 1
Recruiting
Led By Michael D Weiss, MD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Either a 10-minute Apgar < 5 or a continued need for ventilation
Eligible infants are >36 0/7th weeks gestation
Must not have
A diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities
Clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 18 - 20 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether melatonin, a naturally occurring substance, can help improve outcomes for infants with HIE when used in addition to the standard therapy of induced systemic hypothermia.

Who is the study for?
This trial is for newborns over 36 weeks gestation with Hypoxic-Ischemic Encephalopathy (HIE). They must have had an acute event at birth, show signs of brain dysfunction early on, and meet specific blood criteria. Infants already receiving cooling therapy within 6 hours of birth are eligible. Those with suspected meningitis, metabolic disorders, severe hypoglycemia, or significant congenital issues cannot participate.
What is being tested?
The study tests melatonin's ability to protect the brain in combination with induced hypothermia in infants suffering from HIE. It aims to find the right dose of melatonin that could help minimize brain cell death by acting as a free radical scavenger and reducing inflammation.
What are the potential side effects?
While not explicitly stated here, potential side effects may include sleepiness due to melatonin's role in regulating sleep cycles. Other possible reactions might be minor digestive disturbances or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My newborn had a low Apgar score or needed help breathing after birth.
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My baby was born after 36 weeks of pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was born with abdominal issues and other birth defects or genetic conditions.
Select...
I show signs of meningitis during a sepsis check.
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I have high ammonia levels and low blood sugar.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 18 - 20 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 18 - 20 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Bayley-III Index Scores (Cognitive, Language, and Motor) will be used for neurological outcome assessment
Number of participants with treatment-related adverse events as assessed by MedDRA ??? This is something the PI/Team needs to agree on which one to use.
Peak Plasma Concentration (Cmax) of Melatonin 0.5 mg/kg.
+3 more
Secondary study objectives
Bayley-III Index Scores Subscales (Receptive and Expressive Language, Fine and Gross Motor) will be used for neurological outcome assessment
Evaluation of The Impact of Melatonin using Magnetic Resonance Image (MRI)

Side effects data

From 2014 Phase 2 trial • 40 Patients • NCT01114373
42%
Fatigue
39%
Early Morning Wakening
36%
Daytime drowsiness
11%
Weakness
11%
Dizziness
11%
Nausea
11%
Blurred vision
100%
80%
60%
40%
20%
0%
Study treatment Arm
Melatonin
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Participants 21-30Experimental Treatment4 Interventions
This group will receive Melatonin dose of 5 mg/kg enterally, only if the group Participants 11-20 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life. The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns. Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Group II: Participants 11-20Experimental Treatment4 Interventions
This group will the Melatonin dose of 3 mg/kg enteral, only if the group Participants 1-10 has meet the safety goals. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life. The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns. Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Group III: Participants 1-10Experimental Treatment4 Interventions
This group will receive a 0.5 mg/kg enteral dose of Melatonin. The first dose will be administered via enteral route within 12 hours of life with a target of 6 hours of life. The melatonin will be administered as a single dose for the first 5 participants in allowing the investigators to determine if the dosing frequency has the potential to decrease in the elimination with hypothermia. The next 5 subjects who will receive multiple doses if there are not any safety concerns. Additionally, the participants will have the following test performed: Magnetic Resonance Imaging (MRI), Neurological Outcome Assessment, Pharmacokinetics, and safety monitoring.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melatonin
2014
Completed Phase 4
~1150

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,385 Previous Clinical Trials
762,537 Total Patients Enrolled
Thrasher Research FundOTHER
133 Previous Clinical Trials
96,742 Total Patients Enrolled
Michael D Weiss, MDPrincipal InvestigatorUniversity of Florida
3 Previous Clinical Trials
1,096 Total Patients Enrolled

Media Library

Melatonin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02621944 — Phase < 1
Hypoxic-Ischemic Encephalopathy Research Study Groups: Participants 11-20, Participants 21-30, Participants 1-10
Hypoxic-Ischemic Encephalopathy Clinical Trial 2023: Melatonin Highlights & Side Effects. Trial Name: NCT02621944 — Phase < 1
Melatonin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02621944 — Phase < 1
~10 spots leftby Mar 2026