The Project

Background

Despite excellent prenatal care and monitoring during delivery, one to four per 1000 births are complicated by insufficient oxygen supply, which is the most common birth complication causing long-term developmental impairments. In general, this lack of oxygen causes damage to all organs, but the brain is particularly sensitive. Here cells are dying the fastest if the blood does not transport enough oxygen. Damage ranges from temporary problems which disappear by themselves to severe developmental impairments, paralysis and long-term disabilities. Standard treatment of this complication is to slightly cool down the newborn’s body temperature. The newborn’s body is cooled down to 33.5 degrees Celsius for 72 hours and afterwards slowly warmed up again. Small and preliminary clinical trials have shown that the administration of the drug “allopurinol” immediately after birth may help to further reduce the long-term impairments. This is to be examined by the study beginning now.

Current study

The ALBINO study (Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome), funded by the European Union, aims at showing the efficacy of the drug “allopurinol”. For this purpose, 900 newborns who have suffered from oxygen deficiency during birth will be examined. Even in large hospitals there are fewer than five such babies per year. That is why it is necessary to conduct an extensive multicenter international study in order to recruit the patient number.

The drug, which has traditionally been used to treat chronic gout in adults, reduces the uric acid concentration in the blood. For a long time the exact effect of “allopurinol” on patients with oxygen deficiency was unknown. Over the last few years scientists, in a first step, were able to describe the mechanisms which lead to brain damage as a result of oxygen deficiency. These processes do not arise immediately in the deficiency situation but within the first hours after the incident. Thus, there is a “therapeutic window” for treatments which might protect the brain cells?