Pitt Public Health will lead data coordination for a trial on a deadly condition common in preterm infants

The National Heart, Lung and Blood Institute has selected the University of Pittsburgh as the Data Coordinating Center for a $5.5 million trial to help guide parents on treatment options for patent ductus arteriosus, or PDA — an extra blood vessel that develops in utero and allows blood circulation to skip the lungs of a developing baby.

Wendy King, associate professor of epidemiology at Pitt’s School of Public Health, and Stephen Wisniewski, vice provost at Pitt and co-director of Pitt Public Health’s Epidemiology Data Center, are principal investigators on the trial titled, “Percutaneous intervention versus observational trial of arterial ductus in lower gestational age infants,” or PIVOTAL. 

Usually, either before birth or shortly thereafter, the extra vessel shrinks and closes. But sometimes, particularly in premature infants, the PDA is large and more likely to stay open, which may require the infant to be put on mechanical ventilation and lead to problems that strain and enlarge the child’s heart. The best course of action to help the newborn — medication, insertion of a catheter or corrective surgery — isn’t always obvious.

“Using the best data science methods is critical to answering clinical questions, which in this trial could prevent chronic lung disease, intestinal injury, brain damage, congestive heart failure and even mortality among preterm infants,” King said.

In preterm infants on breathing support with PDAs that affect the flow of their blood, the trial will compare cardiopulmonary outcomes such as days free of mechanical ventilation following PDA closure via a minimally invasive heart catheter closure-device versus supportive care without closure. The study also will evaluate safety and improvement in neurodevelopmental outcomes.