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Study on the Effect of Allopurinol and Hypothermia for Newborns with Hypoxic-Ischemic Encephalopathy

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What is this trial about?

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

This clinical trial is focused on studying a condition known as hypoxic-ischemic encephalopathy (HIE), which is a type of brain injury that can occur in newborns due to complications during labor and childbirth, such as issues with the placenta or umbilical cord. The study is investigating the effects of a treatment using a medication called allopurinol sodium, which is being tested alongside standard care practices, including therapeutic cooling, to see if it can help reduce the risk of death or severe developmental problems in affected infants.

The purpose of the study is to determine if early treatment with allopurinol sodium can improve outcomes for newborns showing early signs of HIE. The study will compare the effects of this medication to a placebo, which is a substance with no active ingredients, to see if there is a significant difference in the health and development of the children at two years of age. The main focus is on reducing the chances of severe neurodevelopmental issues, such as cerebral palsy or cognitive and language impairments.

Participants in the study will receive either allopurinol sodium or a placebo shortly after birth, in addition to the usual care provided for HIE. The study will monitor the children over a period of time to assess their development and health outcomes. The goal is to gather information that could lead to better treatment options for newborns with this serious condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as severe perinatal metabolic acidosis or early signs of brain injury known as hypoxic-ischemic encephalopathy (HIE).

  2. Step 2

    Initial treatment phase

    The initial treatment involves the administration of allopurinol sodium in addition to standard care, which may include therapeutic hypothermia if indicated. This is done to assess its effect on reducing the risk of death or severe neurodevelopmental impairment.

    The medication is given as a solution for infusion through intravenous use.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, regular monitoring is conducted to evaluate the patient's response to the treatment. This includes assessing neurodevelopmental outcomes using standardized tests such as the Bayley Scales of Infant and Toddler Development.

    The primary focus is on survival without severe neurodevelopmental impairment at the age of two years.

  4. Step 4

    Completion of the study

    The study is expected to conclude by June 30, 2026. At this point, final assessments are made to determine the long-term effects of the treatment on neurodevelopmental outcomes.

Who can join the trial?

6 criteria

  • The newborn must have a **brain injury** called **hypoxic-ischemic encephalopathy (HIE)**, which can happen due to problems during labor and childbirth, like issues with the placenta or umbilical cord.
  • The newborn must have **severe perinatal metabolic acidosis**. This means there is too much acid in the baby's blood shortly after birth, which can be a sign of stress or lack of oxygen.
  • The newborn must have needed **cardiopulmonary resuscitation (CPR)** at 5 minutes after birth. CPR is an emergency procedure to help the baby breathe and circulate blood.
  • The newborn must show **early clinical signs** of a condition that might be developing in the brain, known as **encephalopathy**. This means there are early signs that the brain might not be working properly.
  • The study is open to both **male and female** newborns.
  • The study includes newborns who are considered a **vulnerable population**, meaning they need special protection and care.

Who cannot join the trial?

5 criteria

  • Newborns who do not show early signs of **hypoxic-ischemic encephalopathy (HIE)**. This is a type of brain injury that happens when the brain doesn't get enough oxygen and blood.
  • Newborns who are not experiencing **asphyxia**, which means they are not having trouble getting enough oxygen at birth.
  • Newborns who are not eligible for **therapeutic hypothermia**, a treatment that cools the body to help protect the brain after a lack of oxygen.
  • Newborns with other medical conditions that might interfere with the study or its results.
  • Newborns whose parents or guardians do not consent to participate in the study.
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Investigated drugs

Allopurinol is a medication being studied for its potential benefits in newborns who have experienced asphyxia and show early signs of brain injury due to lack of oxygen. The trial is investigating whether giving allopurinol shortly after birth, in addition to standard treatments like cooling therapy, can help reduce the risk of death or severe developmental problems, such as cerebral palsy or cognitive and language impairments, by the age of two.

What is already known about the treatment

Allopurinol – Allopurinol is administered orally or intravenously and is currently being studied for its potential benefits in newborns with brain injury known as hypoxic-ischemic encephalopathy (HIE). This condition can occur due to complications during childbirth, such as placental abruption or umbilical cord issues. The medication is primarily used to reduce uric acid levels in the body, which can help prevent gout and kidney stones. In the context of HIE, allopurinol is being evaluated for its ability to reduce the risk of death or severe neurodevelopmental impairment when used alongside standard treatments like therapeutic hypothermia. It works by inhibiting the enzyme xanthine oxidase, which is involved in the production of uric acid, and is classified as a xanthine oxidase inhibitor.

Investigated diseases

Hypoxic-Ischemic Encephalopathy (HIE) – This condition occurs when the brain does not receive enough oxygen and blood flow, often due to complications during labor and childbirth, such as placental abruption or umbilical cord issues. It primarily affects newborns and can lead to brain damage. The progression of HIE can vary, with some infants experiencing mild effects while others may develop severe neurological impairments. Symptoms may include difficulty breathing, poor muscle tone, and seizures. Over time, affected children may face challenges in motor skills, cognitive development, and language abilities. The severity of these outcomes can depend on the extent and duration of the oxygen deprivation.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511322-31-00Protocol codeAlbinoEstimated enrolment503 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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