Cell-Free DNA Analytical Validation Supporting Small Blood Volume Test for Infants and Neonates

Project Summary:

One in 100 babies born both in Wisconsin and nationally has congenital heart disease (CHD), and 30% of affected children require surgery during infancy. However, an eastern region in the state of Wisconsin has more children born with CHD than the national average. Children's Wisconsin (CW) provides care for 60% of Wisconsin newborns with CHD. CW pediatric cardiac surgeons and cardiologists monitor infants undergoing CHD surgery with cutting-edge cell-free DNA testing to prevent and mitigate poor outcomes. AHW funding will allow these providers to pursue a small blood volume test for neonates and infants that would be used in tandem with current monitoring to provide advance warning of poor outcomes after surgery.

AHW funding will allow the project team to build on previous research that utilized higher volumes for measuring nucleic acids in the blood of pediatric patients undergoing surgery for CHD at CW. The subset of neonates and infants among all pediatric patients in an initial study had a higher incidence of poor outcomes after surgery. Because of blood volume restrictions, the team was unable to study neonates weighing under three kilograms and at times weighing over three kilograms. To focus future studies on all neonates and infants who undergo cardiac surgery for CHD will require use of lower blood volumes. It is well known that most research begins with adult subjects, and pediatric patients must often wait for access to drugs and devices developed. The team’s work in measuring nucleic acid levels began with a pediatric population, and this project will set them up from the start to study our blood test in neonates and infants with CHD who are in the highest risk category for cardiac surgery.