Renewed Funding for NPCTU

We are excited to announce that Rusty McCulloh, MD, and his team competed successfully for funding to continue the Nebraska Pediatric Clinical Trials Unit (NPCTU) for another five yeaISPCTN logors! This $2.1 million grant, awarded by the National Institutes of Health Office of the Director, ensures that the NPCTU can continue to engage in important clinical trials and rural outreach as part of the IDeA States Pediatric Clinical Trials Network (ISPCTN). This network, with a footprint in 18 states, is the interventional component of the NIH Environmental Influences on Child Health Outcomes (ECHO) Program. Its mission is to improve research infrastructure in underfunded states, as well as to include rural and underserved pediatric populations in multisite clinical trials.

Cycle 1 

During the first grant period (2016-2020), the NPCTU was highly involved in ISPCTN activities, contributing to four clinical trials on a range of topics in child health, including obesity, asthma, neonatal opioid withdrawal syndrome, and characterization of understudied drugs in children. So far, projects supported by the NPCTU during Cycle 1 have resulted in 9 peer-reviewed publications.

The NPCTU partnered in all four of the network’s clinical studies during Cycle 1:

Throughout Cycle 1, the NPCTU also provided infrastructure support to the Pediatric Research Office (PRO) and Child Health Research Institute (CHRI). The NPCTU grew to include a junior investigator, research nurse, clinical study coordinator and research data analyst, with additional funding to support a human factors analyst and grant writer for CHRI. The team also assisted with the development of the CHRI Research Specimen Laboratory and Nebraska Pediatric Research Registry.

“The NPCTU team has made great progress in building research capacity, training researchers and coordinators to conduct clinical trials, and extending research opportunities to children and communities across Nebraska,” commented Dr. McCulloh. “I am immensely grateful to everyone who has helped make our success possible.”

Looking Ahead to Cycle 2

The NPCTU team will continue to engage in ISPCTN clinical trials activities and contribute to the study and publication pipelines throughout the second award period. There will also be an increased emphasis on professional development during Cycle 2, with the addition of Kari Simonsen, MD, professor of Pediatric Infectious Diseases, as Senior Faculty Development Leader. She will provide mentorship to NPCTU junior investigators Kari Neemann, MD, assistant professor of Pediatric Infectious Diseases, and Ashley Deschamp, MD, assistant professor of Pediatric Pulmonology, focusing on clinical trials skills, leadership and team management, scientific writing skills and career development award submission. The ISPCTN also plans to engage junior faculty in the submission and evaluation of pilot proposals throughout the upcoming grant cycle.

Finally, the upcoming award period will see a renewed focus on rural outreach and engagement in Nebraska and throughout the Great Plains region. Kate Heelan, PhD, with the University of Nebraska at Kearney, will act as a co-investigator. She will assist the NPCTU with rural recruitment and retention activities, local healthcare provider training, and engagement of a rural community advisory board to discuss clinical trials protocols and identify areas for pediatric research that are important to the local community.

Dr. McCulloh eagerly anticipates continued achievements. “Despite the pandemic, our NPCTU team has enrolled dozens of patients across greater Nebraska in cutting-edge clinical trials. If the first four years are any clue, the next five years of the NPCTU will see fantastic growth in clinical trials opportunities and new knowledge that will improve the lives of Nebraska children.”

by Rachel Wellman and Matthew Sandbulte | 15 December 2020