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Melatonin for Neonates with Hypoxic Ischemic Encephalopathy (HIE)

This study is looking at whether melatonin can help babies with Hypoxic Ischemic Encephalopathy (HIE), a brain injury that can happen around birth. Currently, only about half of babies treated with cooling therapy (hypothermia) have good outcomes. Researchers want to see if melatonin, a natural substance, can work with hypothermia to improve these outcomes. This study will test different doses of melatonin (0.5 mg/kg, 3 mg/kg, and 5 mg/kg) to find the safest and most effective amount. We are looking for babies who are 36 weeks gestation or older, within 6 hours of birth, and meet specific blood test criteria related to HIE. The goal is to see how well melatonin is tolerated and if it can improve brain development, measured around 18-20 months of age.

Study design
This is an interventional study with 30 participants, divided into three groups to test increasing doses of melatonin. The study aims to identify the maximum tolerated dose.
What's involved
Participants will receive melatonin doses, have blood tests to measure melatonin levels, and undergo an MRI scan between 7-12 days of age. Neurological assessments will be performed around 18-20 months of age.
Compensation
Not stated in the trial record.
Follow-up
Participants will have neurological outcome assessments performed at approximately 18-20 months of age.

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NCT02621944

Melatonin as a Neuroprotective Therapy in Neonates With HIE Undergoing Hypothermia

Recruiting
EARLY_PHASE1Up to 6InterventionalTreatment
University of Florida
~70 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:MelatoninMagnetic Resonance ImagingPharmacokineticsNeurological Outcome Assessment

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To identify the maximum tolerated dose of Melatonin
Measured over Changes in Baseline to day 3
+5 more outcomes measured

Conditions

Hypoxic Ischemic Encephalopathy

Explore related trials

Hypoxic Ischemic Encephalopathy

Where it's being run

2 sites across 1 states
Florida2

Study leadership

  • Michael D Weiss, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Alison A McMurray, M.A.M.C.
[email protected]
3526275016
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eligible infants are \>36 0/7th weeks gestation,
pH (cord or neonatal) \<7.0,
base deficit \>16 mEq/L,
no available blood gas,
a cord blood/first hour of life blood gas with pH \> 7.0 and \< 7.15,
base deficit between 10 and 15.9 mEq/L,
infants must have a history of an acute perinatal event,
either a 10-minute Apgar \< 5 or a continued need for ventilation,
All infants must have signs of encephalopathy within 6 hours of age using the modified Sarnat scoring system,
neonates cooled within 6 hours of birth will be included in the study.

Exclusion

suspected inborn errors of metabolism (elevated ammonia) and hypoglycemia,
clinical signs and symptoms consistent with meningitis detected upon sepsis evaluation,
a diagnosis of congenital abdominal surgical problems along with multiple congenital anomalies and/or chromosomal abnormalities.

What this trial measures

  • To identify the maximum tolerated dose of MelatoninChanges in Baseline to day 3

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

  • Bayley-III Index Scores (Cognitive, Language, and Motor) will be used for neurological outcome assessmentApproximately 18 - 20 Months

    All raw scores will be transformed into norm-referenced standard scores (scale mean = 100 with s.d. = 15) using the Bayley-III scoring software published with the test. To dichotomize "good" and "poor" outcomes for statistical analysis, standardized scores that are at or greater than one standard deviation below the normative sample mean published with the test (i.e., standard scores \< 85) will be classified as "poor outcome" while higher scores will be classified as "good outcome".

  • Peak Plasma Concentration (Cmax) of Melatonin 0.5 mg/kg.0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)

    HPLC-ESI/MS/MS will be used to measure melatonin concentrations in the serum samples. The two-way ANOVA (treatments are dose level and timepoint) framework for testing. Testing will be done using a likelihood ratio test, either using large-sample theory approximation or using bootstrap.

  • 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.Baseline ongoing to Day 14

    Incidence/Grade of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), laboratory abnormalities Percentage and number of subjects who discontinued for adverse event

  • Peak Plasma Concentration (Cmax) of Melatonin 3 mg/kg.0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)

    HPLC-ESI/MS/MS will be used to measure melatonin concentrations in the serum. The two-way ANOVA (treatments are dose level and timepoint) framework for testing. Testing will be done using a likelihood ratio test, either using large-sample theory approximation or using bootstrap.

  • Peak Plasma Concentration (Cmax) of Melatonin 5 mg/kg.0 (baseline), 3, 5, 6, 12, 24, 48, 96 hours and day 14 (one sample)

    HPLC-ESI/MS/MS will be used to measure melatonin concentrations in the serum samples. The two-way ANOVA (treatments are dose level and timepoint) framework for testing. Testing will be done using a likelihood ratio test, either using large-sample theory approximation or using bootstrap.