This multicenter study was led by Sandra E. Juul, professor of pediatrics and head, Division of Neonatology, at the University of Washington School of Medicine in Seattle. The researchers randomized more than 900 infants to receive either high-dose erythropoietin or a placebo severa; times a week from birth to 32 weeks corrected age, which is how old the baby would be if born on the due date.
‘High-dose erythropoietin treatment does not lower the risk of death or severe brain damage before 2 years of age in children who had been born at a very premature stage. ’
There were no differences in severe side effects between the treatment and placebo groups.
Juul said she was surprised and disappointed by the results.
"There was ample preclinical data to suggest that EPO would decrease neurologic damage that preterm infants suffer," she said.
However, she added, the project team does plan to follow the children in the study as they grow, because testing at 2 years of age may not reflect their later development.
The PENUT (Preterm EPO Neuroprotection Trial) examined the effect of the drug erythropoietin (e-rith-ro-PO-e-tin, "EPO" for short) on the brains of 940 babies born between 24 and 28 weeks. They are the tiniest of preemies - babies born before 37 weeks. Started in 2013, PENUT received $10 million from the National Institutes of Health to enroll and track these babies during their hospital stays and beyond, to 2 years of age. UW Medical Center's team are coordinating the study across 29 hospitals in the United States.
The drug was administered to newborns within 24 hours of birth. The babies then received a total of 10 injections between birth and 32 weeks. Cognitive and neurological tests are then conducted at 2 years.
Erythropoietin is a naturally occurring hormone made by the kidneys. It is involved in production of red blood cells, and is used to treat anemia. Erythropoietin is also found in the brain. Other studies have suggested it may help protect brain cells from injury by controlling immune responses and inflammation.