Ongoing Clinical Trials for Neonatal Encephalopathy
Currently, there is 1 ongoing clinical trial investigating treatments for neonatal encephalopathy, specifically focusing on hypoxic-ischemic encephalopathy (HIE) in newborns. This trial is testing the combination of allopurinol medication with standard cooling therapy to improve outcomes for affected infants, and is being conducted across multiple European countries.
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 serious condition affecting newborns called hypoxic-ischemic encephalopathy, which is a type of brain injury that occurs when the brain doesn’t 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 focus: The study is testing whether a medication called allopurinol sodium, when given alongside standard cooling therapy, can help reduce the risk of death or severe developmental problems in affected infants. The researchers want to see if early treatment with allopurinol can improve outcomes for newborns showing early signs of this brain injury. The trial will follow the children until they are two years old to assess their development and check for issues such as cerebral palsy, cognitive difficulties, or language impairments.
Investigational drug: Allopurinol is the medication being tested in this trial. While it is commonly used to reduce uric acid levels in conditions like gout, this study is exploring whether it can protect the brain after oxygen deprivation. The medication is given through intravenous infusion shortly after birth, in addition to the usual care provided for babies with this condition, which may include therapeutic hypothermia.
Who can participate: The trial is looking for newborns of both sexes who meet specific criteria:
- The baby must have hypoxic-ischemic encephalopathy, a brain injury caused by lack of oxygen during birth
- The baby must have severe perinatal metabolic acidosis, meaning there is too much acid in the blood shortly after birth
- The baby needed cardiopulmonary resuscitation at 5 minutes after birth
- The baby shows early clinical signs that the brain might not be working properly
Who cannot participate: The trial excludes certain newborns, including:
- Newborns who do not show early signs of hypoxic-ischemic encephalopathy
- Newborns who are not experiencing asphyxia or trouble getting enough oxygen at birth
- Newborns who are not eligible for therapeutic hypothermia
- Newborns with other medical conditions that might interfere with the study
- Newborns whose parents or guardians do not consent to participation
The study involves regular monitoring to evaluate how the baby responds to the treatment. This includes assessing neurodevelopmental outcomes using standardized tests called the Bayley Scales of Infant and Toddler Development. The trial is expected to conclude by June 30, 2026.
Summary
There is currently one active clinical trial addressing neonatal encephalopathy, specifically hypoxic-ischemic encephalopathy. This condition occurs when newborns experience insufficient oxygen and blood flow to the brain during birth, which can lead to serious developmental challenges.
The trial is notably widespread across Europe, being conducted in nine countries: Austria, Belgium, Estonia, Finland, Germany, Italy, Netherlands, Norway, and Spain. This multi-country approach allows for a larger and more diverse group of participants, which can help researchers better understand whether the treatment works across different populations.
The focus on combining allopurinol with therapeutic hypothermia represents an effort to enhance existing standard care. Therapeutic cooling has already been established as helpful for babies with this condition, and researchers are now investigating whether adding allopurinol medication can provide even better protection for the developing brain. The long-term follow-up until age two is particularly important, as it allows researchers to assess whether the treatment has lasting benefits on a child’s development, including motor skills, thinking abilities, and language development.
