Children’s Healthcare of Atlanta and Emory University Lead National Trial Aiming to Improve Survival

ATLANTA (July 24, 2025) – Children’s Healthcare of Atlanta and Emory University are leading a national multi-site trial to determine the best threshold for platelet transfusions in extremely preterm infants admitted to the Neonatal Intensive Care Unit (NICU) at Arthur M. Blank Hospital. These babies generally have the highest incidence of abnormally low platelets in the blood and bleeding, as well as the highest mortality among all babies admitted to the NICU. Led by Ravi Patel, MD, MSc, Director of Neonatal Clinical Research and Neonatologist for Children’s, the goal of the trial is to try to improve survival and outcomes for these tiny patients.

“The trial will test the hypothesis that among extremely preterm infants born at 23 to 26 weeks gestation, a low platelet transfusion threshold, compared to a high threshold, will improve survival without major or severe bleeding up to 40 weeks,” said Dr. Patel, principal investigator.

Infants born extremely preterm during these weeks have a higher risk of developing bleeding and not surviving compared to more mature infants. This is especially true in the first week after birth, a particularly high-risk period for bleeding. A platelet transfusion may decrease the risk of bleeding by helping clots form, but the correct threshold for giving these transfusions based on their platelet count, a routine test in the NICU, is not yet clearly understood by neonatal researchers. Once known, the hope is that giving the transfusion at the correct threshold will improve bleeding and potentially survival.

“We hope knowledge generated from the trial may improve outcomes in our most vulnerable patients,” said Dr. Patel, who is also a professor of Pediatrics at Emory University School of Medicine.

As Principal Investigator, Dr. Patel will oversee the seven-year, multi-site, randomized trial and lead the clinical coordinating center through NICUs at Children’s. Martha Sola-Visner, MD, director of the Newborn Medicine Clinical Research Program at Boston Children’s and professor in Pediatrics at Harvard Medical School, will serve as co-principal investigator of the clinical coordinating center. They aim to enroll more than 2,000 infants across all sites with about 100 from Children’s. Research Triangle Institute (RTI) International will serve as the data coordinating center.

The trial is funded by $8.7 million National Institutes of Health (NIH) grant and will be conducted at 15 NICUs across the country through the Neonatal Research Network, a consortium of NICUs with established site research infrastructure and extensive experience conducting multicenter clinical trials with early recruitment of these high-risk infants, as well as six additional centers in the U.S. The Neonatal Research Network is part of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Posted by CHA