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Study of intravenous melatonin safety and dosing in newborns with moderate to severe hypoxic-ischaemic encephalopathy receiving therapeutic hypothermia treatment

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on newborns with hypoxic-ischaemic encephalopathy (HIE), a serious brain condition that occurs when a baby's brain doesn't receive enough oxygen around the time of birth. The study will test a new form of melatonin, a substance given through an intravenous infusion, in combination with therapeutic hypothermia (cooling treatment) which is the current standard care for these babies.

The purpose of this research is to determine if giving high doses of melatonin through a vein is safe for newborns with moderate to severe HIE and to find the most appropriate dose for future studies. The study will also measure how the medication moves through the body and monitor the levels of melatonin and the solution it is mixed with in the blood.

During the study, babies will receive different doses of melatonin while undergoing cooling treatment. The medical team will closely monitor the babies' brain activity using special monitoring equipment, take blood samples to measure drug levels, and perform brain scans called MRI to assess the effects of the treatment. The babies' development will be followed using various assessment methods to understand how well they progress after the treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment and preparation

    Your baby will be admitted to the Neonatal Intensive Care Unit (NICU) with a condition called moderate-severe hypoxic-ischaemic encephalopathy (HIE)

    The medical team will ensure your baby is clinically stable and has proper blood pressure monitoring in place

    Your baby will undergo brain activity monitoring using specialized equipment (EEG)

    A central line or proper working IV line will be placed

  2. Step 2

    Treatment administration

    Your baby will receive melatonin through an IV line

    The medication will be given as a solution mixed with a small amount of ethanol

    The treatment will be administered while your baby is undergoing therapeutic cooling treatment

    Blood samples will be taken to monitor melatonin and ethanol levels in your baby's blood

  3. Step 3

    Monitoring period

    Your baby will be continuously monitored using brain activity recordings (EEG)

    Continuous monitoring of brain oxygen levels will be performed using a special light sensor (NIRS)

    Regular blood pressure checks and other vital signs will be monitored

    The medical team will perform regular neurological examinations

  4. Step 4

    Brain imaging

    Between days 4 and 10, your baby will have a brain MRI scan

    Special images will be taken to assess brain tissue and any potential injury

    The scan will include measurements of certain brain chemicals

  5. Step 5

    Follow-up assessments

    Your baby will undergo several developmental assessments

    These include specialized neurological examinations (HINE and HNNE)

    Movement patterns will be assessed (GMA)

    You will be asked to complete developmental questionnaires (ASQ-3)

Who can join the trial?

11 criteria

  • Baby must be admitted to the Neonatal Intensive Care Unit (NICU) with moderate-severe oxygen deprivation-related brain injury
  • Baby must qualify for therapeutic hypothermia (cooling treatment) according to hospital guidelines
  • Baby must be born at or after 36 completed weeks of pregnancy
  • Baby must be clinically stable before receiving the study medication, which means:
    • Having a properly placed central line or working IV line
    • Having normal blood pressure (with or without medication support)
    • Having any seizures under control with medications
    • Having stable vital signs while receiving cooling treatment
    • Being approved as stable by the treating doctor
    • Baby must have blood pressure monitoring through an arterial line before receiving the study medication
    • For initial participants in the study: baby's condition must not be classified as severe based on brain monitoring (EEG) and neurological examination
    • Parents, guardians, or legally authorized representatives must provide informed consent for participation

Who cannot join the trial?

11 criteria

  • Infants who do not show signs of moderate to severe hypoxic-ischemic encephalopathy (HIE) - a condition where the brain doesn't receive enough oxygen and blood flow around the time of birth
  • Infants older than 6 hours of life, as treatment needs to begin within this timeframe
  • Newborns with major birth defects or genetic disorders
  • Infants with severe bleeding disorders
  • Babies with severe liver or kidney dysfunction
  • Infants who are already participating in other clinical trials
  • Cases where parents or legal guardians have not provided informed consent
  • Newborns with severe blood pressure instability
  • Infants with known allergies to melatonin or any components of the study medication
  • Babies who have received other experimental treatments before enrollment
  • Infants with conditions that would interfere with the study procedures or evaluation
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Investigated drugs

  • Melatonin

    A hormone naturally produced in the body that helps regulate sleep-wake cycles. In this trial, it is being tested in a new intravenous formulation to help protect the brain in newborn babies who have experienced oxygen deprivation during birth (hypoxic-ischaemic encephalopathy). The medication is being studied alongside therapeutic hypothermia (cooling treatment) to potentially reduce brain damage and disability in these infants.

  • Therapeutic Hypothermia

    A medical treatment that involves carefully cooling a baby's body temperature. This cooling therapy is the current standard treatment for newborns who have experienced oxygen deprivation at birth. It helps reduce brain injury and improve outcomes for these babies.

What is already known about the treatment

Melatonin (intravenous formulation) - A novel intravenous formulation of melatonin being investigated in clinical trials for treating newborns with moderate to severe Hypoxic-Ischaemic Encephalopathy (HIE) in combination with therapeutic hypothermia. This medication is administered through intravenous infusion and works by protecting brain cells from damage caused by oxygen deprivation and reduced blood flow. The medication belongs to the class of neurohormones and acts as a powerful antioxidant and neuroprotective agent, helping to reduce the severity of brain injury and potentially improving outcomes in affected newborns. Current clinical research is focused on establishing its safety profile and determining optimal therapeutic doses that can achieve plasma concentrations of 15-30mg/L while maintaining safe blood alcohol levels.

Investigated diseases

Hypoxic-Ischemic Encephalopathy (HIE) - A brain injury that occurs when the brain doesn't receive enough oxygen and blood flow. This condition typically develops during or near the time of birth when something disrupts the normal flow of oxygen to a baby's brain. The reduced oxygen and blood flow causes damage to brain tissue, which can affect various areas of brain function. The condition can vary in severity from mild to severe, with different levels of impact on brain function. HIE can affect multiple areas of the brain, including those responsible for movement, learning, and development. The initial phase of injury is followed by a complex cascade of events in the brain tissue that can continue for several hours or days.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2025-520538-49-00Protocol code146647Estimated enrolment60 patientsSponsorUniversity College London

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).