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RTI coordinated the U.S.-based clinical trial, which found that synthetic bone marrow stimulant reduces blood transfusions but does not improve neurodevelopment
RESEARCH TRIANGLE PARK, N.C. — A new study conducted by the NICHD Neonatal Research Network (NRN) and led by the University of Utah in collaboration with independent scientific research institute RTI International, and other partners, has found that weekly administration of darbepoetin to extremely preterm infants reduced the need for blood transfusions, but it did not improve cognitive outcomes compared with placebo.
The findings were published in the Journal of the American Medical Association Pediatrics (JAMA Pediatrics).
RTI served as the Data Coordinating Center (DCC) for the randomized clinical trial, with Abhik Das, Ph.D., Distinguished Fellow, serving as principal investigator and Sylvia Tan as senior statistician. The trial was co-funded by NHLBI and conducted across 19 U.S. hospitals that are part of the NRN.
“While darbepoetin increased red cell mass and reduced the need for blood transfusions in the Neonatal Intensive Care Unit, our findings show no improvement in cognitive outcomes at two years,” said Das. “This suggests that, for preterm infants, the benefits of darbepoetin may be limited to hematologic effects rather than neurodevelopment.”
The trial enrolled 650 infants born between 23- and 29-weeks’ gestation. Infants were randomized to receive either weekly darbepoetin or placebo during their hospitalization, with follow-up assessments completed at 22 to 26 months.
All study participants had similar average cognitive development test scores, with no significant difference between the groups, mean of 80.7 in the treatment group versus 80.1 for the placebo group. However, 40% of infants in the darbepoetin group did not need any blood transfusion during hospitalization, compared with only 21% in the placebo group. Infants in the treatment group also had significantly increased red cell mass resulting in higher hematocrit values, and fewer donor exposures.
The study’s results underscore the need for ongoing research to identify effective strategies for improving long-term neonatal outcomes.
RTI International is an independent scientific research institute dedicated to improving the human condition. Our vision is to address the world's most critical problems with technical and science-based solutions in pursuit of a better future. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across social, statistical, data, and laboratory sciences, engineering, and other technical disciplines to solve the world’s most challenging problems.
For more information, visit www.rti.org.