ABOUT PIVOTAL

PIVOTAL is a multi-center randomized clinical trial to compare treatments for PDA in extremely preterm infants. Twenty-three sites across the country are participating.

Nationwide Children’s Hospital (NCH) – Clinical Coordinating Center

Environment Contribution to Success – Nationwide Children’s Hospital (NCH) is a 673-bed primary pediatric hospital with 18,182 inpatient discharges according to 2018 data. It is also the pediatric academic teaching hospital in partnership with The Ohio State University College of Medicine.

Nationwide Children’s Hospital covers over 120 clinical specialties and was listed 7th in the nation in the 2019-2020 U.S.

News and World Report rankings for Best Children’s Hospitals. It is one of the largest children’s hospitals in the nation, serving over 1.5 million patients per year. The main hospital building, opened in 2012, consists of 12 stories and 750,000 square feet of space. The Division of Neonatology has 33 neonatologists and 10 clinical fellows, making it one of the largest in the nation and ensuring protected research time for tenure-track faculty.

Nationwide Children’s Hospital
Carl H. Backes, Jr, MD

Carl H. Backes Jr., MD

Principal Investigator

Carl H. Backes, Jr. is a member of the Center for Perinatal Research at The Research Institute at Nationwide Children’s Hospital. He is an Associate Professor of Pediatrics at The Ohio State University College of Medicine, and Attending Neonatologist and Attending Cardiologist at Nationwide Children’s Hospital. His clinical interests include the care of premature infants born with congenital heart disease. His research interests involve improving outcomes among premature infants with cardiovascular or hemodynamic perturbations.

Jonathan L. Slaughter, MD, MPH

Jonathan L. Slaughter, MD, MPH

Principal Investigator

Jonathan L. Slaughter is a neonatologist and principal investigator in the Center for Perinatal Research within The Abigail Wexner Research Institute at Nationwide Children’s Hospital and an associate professor of Pediatrics at The Ohio State University. Dr. Slaughter’s ultimate goal is to improve outcomes important to neonatal patients and their families through research that leads directly to improvements in neonatal clinical care. His patient-centered research program focuses on comparative effectiveness research to determine which treatments work best for neonatal patients given specific clinical circumstances and patient characteristics.

Epidemiology Data Center (EDC) – Data Coordinating Center

The EDC at the University of Pittsburgh School of Public Health provides a research environment in which complex health questions can be answered using the combined tools of biology and statistics. The EDC collaborates with clinical researchers to design, conduct, and analyze multicenter randomized clinical trials and epidemiological studies. To contribute to the development of new knowledge, the EDC develops and refines data collection, data management, computing, and statistical methods, with the ultimate goal of advancing prevention and treatment of disease.

Epidemiology Data Center
Stephen R Wisniewski, PhD

Stephen R Wisniewski, PhD

Principal Investigator

Stephen R Wisniewski’s primary area of research is in the conduct of multi-center trials. Over the course of his career he considers himself lucky to have been involved in the design and analysis of seminal trials evaluating the efficacy of treatments in a number of different areas endophthalmitis, depression, bipolar disorder, and traumatic brain injury. He is currently involved in several large-scale research collaborations evaluating treatments for traumatic brain injury, pulmonary conditions (e.g., idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease) and complications related to trauma (e.g., pain medication, management of blood products, airway management).

Wendy C King, PhD

Wendy C King, PhD

Principal Investigator

Wendy King has been a faculty member of the EDC for 18 years. She has been involved in the design and analysis of several NIH-funded multi-center consortiums which include the largest North American studies of bariatric surgery and hepatitis B virus (HBV), and of randomized clinical trials of behavioral weight loss interventions in pediatric and adult populations. She is currently overseeing large-scale research collaborations evaluating the physiology of weight loss maintenance, novel biomarkers of HBV, and co-infection of HIV among adults with HBV. She is also involved in several COVID-19 surveillance projects. She is excited to collaborate with NCH and Children’s Hospitals across the country to determine the optimal treatment of patent ductus arteriosus (PDA), thereby improving critical outcomes among premature infants.