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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.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 18 - 20 months

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%

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

0 / 5Eligibility criteria met