Ongoing Clinical Trials for Neonatal Asphyxia
Currently, there is one ongoing clinical trial investigating treatment options for neonatal asphyxia, specifically focusing on newborns with hypoxic-ischemic encephalopathy (HIE). This trial is being conducted across multiple European countries and is testing the medication allopurinol in combination with standard cooling therapy to improve outcomes for affected infants.
Clinical trial locations
- Austria
- Belgium
- Estonia
- Finland
- Germany
- Italy
- Netherlands
- Norway
- Spain
Study on the Effect of Allopurinol and Hypothermia for Newborns with Hypoxic-Ischemic Encephalopathy
This clinical trial is investigating a treatment approach for newborns who have experienced a type of brain injury called hypoxic-ischemic encephalopathy, which occurs when the brain does not receive enough oxygen and blood flow during labor and childbirth. This can happen due to complications such as problems with the placenta or umbilical cord.
Main inclusion criteria:
- Newborns with brain injury known as hypoxic-ischemic encephalopathy caused by complications during labor and childbirth
- Evidence of severe perinatal metabolic acidosis, meaning too much acid in the baby’s blood shortly after birth
- Required cardiopulmonary resuscitation at 5 minutes after birth to help with breathing and blood circulation
- Showing early clinical signs that the brain might not be working properly
- Both male and female newborns can participate
Main exclusion criteria:
- Newborns who do not show early signs of hypoxic-ischemic encephalopathy
- Newborns who are not experiencing difficulty getting enough oxygen at birth
- Newborns who are not eligible for therapeutic hypothermia (cooling treatment)
- Newborns with other medical conditions that might interfere with the study
- Newborns whose parents or guardians do not consent to participation
Focus and goal of the trial:
The study aims to determine whether early treatment with allopurinol sodium, given alongside standard care practices including therapeutic cooling, can improve outcomes for newborns with hypoxic-ischemic encephalopathy. The primary goal is to reduce the risk of death or severe developmental problems in affected infants by the age of two years. Researchers will compare the effects of allopurinol sodium to a placebo to see if there is a significant difference in the health and development of the children. The main focus is on reducing the chances of severe neurodevelopmental issues, such as cerebral palsy or cognitive and language impairments.
The treatment process begins with confirmation of eligibility based on specific criteria. Newborns then receive allopurinol sodium as a solution for infusion through intravenous use, in addition to standard care which may include therapeutic hypothermia. Throughout the study, regular monitoring is conducted to evaluate the patient’s response to treatment, including assessment of neurodevelopmental outcomes using standardized tests such as the Bayley Scales of Infant and Toddler Development. The study is expected to conclude by June 30, 2026, at which point final assessments will be made to determine the long-term effects of the treatment.
Investigational drug:
Allopurinol is the medication being tested in this trial. It is being studied for its potential to help 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 can help reduce the risk of death or severe developmental problems when used in combination with standard treatments like cooling therapy. Allopurinol works by inhibiting an enzyme called xanthine oxidase, which is involved in the production of uric acid in the body. While it is primarily used to reduce uric acid levels to prevent conditions like gout and kidney stones, researchers are now exploring whether it may also provide protective benefits for the brain when oxygen deprivation occurs during birth.
Summary
Currently, one clinical trial is actively recruiting participants to study treatment options for neonatal asphyxia, specifically focusing on hypoxic-ischemic encephalopathy. This trial is being conducted across nine European countries, including Finland, Spain, Germany, Austria, Belgium, Estonia, Italy, Netherlands, and Norway, demonstrating a significant international collaborative effort in addressing this serious condition affecting newborns.
The trial focuses exclusively on allopurinol as the investigational medication, testing whether this drug can improve outcomes when used alongside standard cooling therapy. The study represents an important step in finding better treatment options for newborns who experience oxygen deprivation during birth, with the goal of reducing death and severe developmental impairments. Parents and healthcare providers interested in this trial should note that participation requires specific eligibility criteria and parental consent, and outcomes will be assessed over a two-year period following birth.
