Nationwide Children’s Hospital Selected as Clinical Coordinating Center in Large National Clinical Trial Sponsored by National Heart Lung and Blood Institute (NHLBI)

The trial will investigate treatment options for infants with patent ductus arteriosus (PDA), a condition where a hole that allows a baby to skip circulation to the lungs in utero fails to close after birth.

March 23, 2022

(COLUMBUS, OHIO) – The National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has announced that Nationwide Children’s Hospital has been selected for funding as the Clinical Coordinating Center for the multicenter randomized trial: “Percutaneous intervention versus observational trial of arterial ductus in lower gestational age infants (PIVOTAL)”.

“We are thrilled to be leading the clinical portion of this study,” said Jonathan Slaughter, MD, neonatologist at Nationwide Children’s and principal investigator in the Center for Perinatal Research at the Abigail Wexner Research Institute at Nationwide Children’s. “Our prior research in this area helped to show the need for this trial, and we are so happy to be leading the next steps.”

“The ductus arteriosus is an essential component of fetal circulation that allows blood to bypass the lungs before birth and bridges the two major arteries leading from the heart,” said Carl Backes Jr., MD, neonatologist, cardiologist and principal investigator at Nationwide Children’s. “When infants are born at term, the ductus closes shortly after birth. However, it remains open (patent) in many preterm infants and is associated with multiple harmful complications including lung disease.”

The trial will compare PDA closure via a minimally invasive heart catheter closure-device, in ventilated preterm infants with PDAs that are affecting their hemodynamics, to supportive care without closure. The study will also evaluate safety and improvement in neurodevelopmental outcomes.

The over $5.5 million, 5-year grant to fund the trial will be divided between the clinical coordinating center and the data coordinating center. The Clinical Coordinating Center develops the scientific rationale for the trial and manages subject recruitment at all sites, application of the trial intervention, outcomes follow-up, and dissemination of results. The Data Coordinating Center supports the study design and protocol development, provides data management, conducts statistical analyses, facilitates communication and coordination across the clinical sites, and collaborates in the preparation and dissemination of study results.

The Epidemiology Data Center at the University of Pittsburgh has been named the Data Coordinating Center for the trial. Wendy King, PhD, associate professor of epidemiology, and Stephen Wisniewski, PhD, vice provost and co-director of the Epidemiology Data Center, are the trial’s principal investigators at the University of Pittsburgh.

“It is unclear how to best treat persistent PDA in preterm infants,” said Dr. King. “The use of data science is critical to answering clinical questions; using the best methods leads to determining the truth, which, in this trial, could save lives. We are thrilled to be collaborating with the Clinical Coordinating Center at Nationwide Children’s Hospital on this seminal trial, which will inform best practices in the clinical care of PDA in preterm infants.”

In 2019, the US Food and Drug Administration (FDA), approved a duct occluder (ADO-II AS) (Abbott’s Piccolo device) to close PDA in preterm infants. But the long-term effects on patient outcomes remain unknown. Historically, invasive surgery was the only option to close a PDA if medication was unsuccessful. The new device offers a less invasive approach using a catheter inserted into a leg vein. 

Abbott, the manufacturer of the device, is also contributing funding to the NIH-sponsored trial.

About The Abigail Wexner Research Institute at Nationwide Children's Hospital
Named to the Top 10 Honor Roll on U.S. News & World Report’s 2021-22 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit free-standing pediatric health care systems providing unique expertise in pediatric population health, behavioral health, genomics and health equity as the next frontiers in  pediatric medicine, leading to best outcomes for the health of the whole child.  Integrated clinical and research programs are part of what allows Nationwide Children’s to advance its unique model of care. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s faculty train the next generation of pediatricians, scientists and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities in the U.S., supporting basic, clinical, translational,  behavioral and population health research. The AWRI is comprised of multidisciplinary Centers of Emphasis paired with advanced infrastructure supporting capabilities such as technology commercialization for discoveries; gene- and cell-based therapies; and genome sequencing and analysis. More information is available at NationwideChildrens.org/Research.

About the University of Pittsburgh Schools of the Health Sciences
The University of Pittsburgh Schools of the Health Sciences include the schools of Medicine, Nursing, Dental Medicine, Pharmacy, Health and Rehabilitation Sciences and Public Health. The schools serve as the academic partner to the UPMC (University of Pittsburgh Medical Center). Together, their combined mission is to train tomorrow’s health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care. Since 1998, Pitt and its affiliated university faculty have ranked among the top 10 educational institutions in grant support from the National Institutes of Health. For additional information about the Schools of the Health Sciences, please visit www.health.pitt.edu/.

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About Nationwide Children's Hospital

Named to the Top 10 Honor Roll on U.S. News & World Report’s 2021-22 list of “Best Children’s Hospitals,” Nationwide Children’s Hospital is one of America’s largest not-for-profit free-standing pediatric health care systems providing unique expertise in pediatric population health, behavioral health, genomics and health equity as the next frontiers in pediatric medicine, leading to best outcomes for the health of the whole child. Integrated clinical and research programs, as well as prioritizing quality and safety, are part of what allows Nationwide Children’s to advance its unique model of care. Nationwide Children’s has a staff of more than 13,000 that provides state-of-the-art wellness, preventive and rehabilitative care and diagnostic treatment during more than 1.6 million patient visits annually. As home to the Department of Pediatrics of The Ohio State University College of Medicine, Nationwide Children’s physicians train the next generation of pediatricians and pediatric specialists. The Abigail Wexner Research Institute at Nationwide Children’s Hospital is one of the Top 10 National Institutes of Health-funded free-standing pediatric research facilities. More information is available at NationwideChildrens.org.