Principal Investigator/Program Director (Last, first, middle): Ross, Judith, M.D. Project Summary/Abstract The overall mission of the Delaware Nemours DuPont Hospital for Children IDeA States Pediatric Clinical Trials Network site (DE-Nemours/AIDHC ISPCTN site) is to facilitate implementation of well-designed pediatric clinical trials, recruit underserved/rural children to participate in these clinical trials, and enhance pediatric clinical trial capacity within the IDeA state, DE. DE has notably high rates of infant prematurity and mortality, asthma, obesity, and infants born with neonatal opioid withdrawal syndrome. The opportunity and the potential impact of pediatric clinical advances are significant in DE, whose population (~1 million) serves as a microcosm of the US, demographically, in urban-to-rural citizen ratio and ethnic/racial diversity. It has one major children’s hospital (AIDHC with >90% of DE pediatric admissions), one major obstetric hospital (Christiana Hospital with >80% of DE deliveries, ~7000/year), and a statewide integrated pediatric primary care network (19 community practices). In this renewal application, we demonstrate our progress in creating and sustaining collaborative clinical trials that address strategic health issues and overcome barriers to inclusion of children residing in rural or impoverished areas of DE. The DE ISPCTN site will continue to harness key resources including 1) 19 DE pediatrics and primary care practice-based networks that cover over 65,000 children (23% in rural areas, 19% in poverty and 52% Medicaid), 2) access to historically underrepresented pediatric populations in DE, including rural, African-American and Hispanic/Latino populations, and 3) robust community engagement programs such as the Nemours children's health website KidsHealth, the most- visited pediatric health site (1 million hits/day). We have the human talent, with highly experienced clinical research teams (PI, Co-Is, junior and senior investigators, coordinators, data entry staff) and the clinical research infrastructure (Clinical research center, IRB processes, standard operating procedures). Nemours/ AIDHC has >15 years’ experience with system-wide use of electronic medical records (EPIC) in clinical trials research. These factors allow for highly effective recruitment and retention in current ISPCTN clinical trials and reach rural and underserved children in the state. The DE site will continue to synergize with robust DE IDeA state resources. Further, we delineate how our strengths in community engagement/patient recruitment, clinician and researcher engagement, and clinical research infrastructure capacity building have allowed us to engage in clinical trials in the focus areas in the Environmental influences on Child Health Outcomes (ECHO) Program including Upper/lower airway disorders, Obesity, Pre-/peri-/postnatal outcomes, and Neurodevelop- ment. The DE site will continue to work closely with the ISPCTN Data Coordinating and Operations Center in development and implementation of clinical trials, will collaborate with the overall ECHO program and the NIH, and will expand capacity to engage rural/underserved populations in DE. Provision of this expertise and infra- structure will increase cutting edge clinical trial research aimed at improving public health in DE and the US. PHS 398/2590 (Rev. 05/01) Page _______ Continuation Format Page

Principal Investigator/Program Director (Last, first, middle): Ross, Judith, M.D. Project Narrative Historically, there have been barriers to involvement of many children in the U.S. in state-of-the art pediatric clinical trials. The IDeA States Pediatric Clinical Trials Network (ISPCTN) represents a transformational opportunity to recruit more underserved children to participate in state-of-the-art clinical trials, facilitate implementation of well-designed pediatric clinical trials, and enhance pediatric clinical trial capacity within the IDeA state, Delaware (DE) at Nemours/Alfred I duPont Hospital for Children (AIDHC). The DE- Nemours/AIDHC site participation in the ISPCTN will catalyze new ideas, promote new collaborations, and will engage clinicians, researchers, and the community in well-designed pediatric clinical trials. Provision of this expertise and infrastructure will increase cutting edge clinical trial research with improved efficiencies for initiating and completing clinical trials and improved public health in DE and the Nation. PHS 398/2590 (Rev. 05/01) Page _______ Continuation Format Page