ISPCTN - Nemours Alfred I. duPont Hospital for Children
Nemours Alfred I. duPont Hospital for Children
1600 Rockland Road
Wilmington, DE 19803
Pediatric Research Focus
- The Pediatric Trials Network and the Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care study (PTN/POPs, NICHD, FDA (PI: Marisa Meyer, D.O. (Intensivist, OTM member, coordinator, Karen Kowal). The Nemours/AIDHC ISPCTN site participates in the POPS study and characterizes the pharmacokinetics of understudied drugs in children. The Nemours/AIDHC site is a leading site within the ISPCTN for patient enrollment (current enrollment: 153 patients), and was one of the top enrollers in the ISPCTN network.
- The Vitamin D Supplementation in Children With Obesity Related Asthma (VDORA1) study (PI: Aaron Chidekel, M.D. (DivisionDirector Pulmonology, OTM member), coordinator Karen Kowal). Our site began enrolling in 2019. Ten patients were screened and are potential patients for VDORA2. We are using Research EPIC in the Nemours primary care network to boost recruitment efforts.
- The Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome-Current Experience (ACT NOWS CE) study (PI: DavidPaul, M.D. (Chair of Peds, CCHS, OTM member, Dr. Ross, study coordinators Amy Mackley (CCHS) and Karen Kowal. In 2017, we established a new ISPCTN partnership with Christiana Care Hospital System (CCHS), which is the major DE hospital for newborn deliveries (>6000/year). The site identified and entered 200 eligible babies with NOWS, born in 2017-18, in the ACT NOWS CE registry protocol and was one of the top enrolling ISPCTN sites.
- IAmHealthy study (PI: Thao-Ly Phan, M.D., MPH, (OTM member), coordinator, Karen Kowal). This is a feasibility pilot protocol of a telehealth intervention for children with obesity receiving primary care in rural clinics. to identify best practices for patient identification, recruitment, and retention in a future pediatric obesity study. The DE site for the iAmHealthy Feasibility Trial is one of four sites participating in this trial. Participants are recruited from the Nemours DuPont Pediatrics Milford, DE primary care clinic. The availability of Research EPIC reports allowed us to greatly reduce the time and effort needed to activate our site. Data extraction indicated that 576 patients at our Milford, DE primary care clinic met inclusion criteria of age and BMI. Of these, 78% had public insurance and 57% met the rurality criteria (RUCA ≥ 4). The research team has gained important experience using EpicCare to assist with participant recruitment and implementation of research studies and will leverage this experience for this particular study.
Health Disparities
The top three health disparities that impact children in Delaware are obesity, asthma, and preterm birth.
The opportunity and the potential impact of pediatric clinical advances are significant in DE, whose population (~1M 2014) serves as a socio-demographic microcosm of the US demographically, in urban-to-rural citizen ratio (20% rural) and ethnic/racial diversity (21% African Americans (vs 12% nationally) and 9% Hispanics. In addition, Northern DE is urban, while Southern DE is predominantly rural and has lower socioeconomic status, making it an ideal site to investigate new programs and new approaches to rural healthcare.
View our current research and relevant publications here.
Meet Our Team
Principal Investigator
Judith Ross, M.D. (PI for the ISPCTN-Nemours/Alfred I DuPont Hospital for Children (Nemours/ AIDHC) DE site), is a Professor of Pediatrics at Thomas Jefferson University, Director of Clinical Pediatric Research at Nemours/AIDHC), and Director of the Nemours/AIDHC EXtraordinarY Kids Clinic. She has over 25 years of NIH-and pharmaceutical company-funded pediatric research experience, including the design, analysis, oversight, and successful completion of pediatric clinical trials. Her research has focused on endocrine and neurodevelopmental outcomes in children with X and Y chromosome disorders (XYY syndrome, Klinefelter syndrome, Turner syndrome). Results of this research has elucidated neurophysiological, pathological, and molecular genotype-phenotype relationships, and the role of selected X and Y genes in children in health and disease. She has successfully conducted more than 50 site-based and multi-center clinical trials (currently, 12 trials). As an active clinical researcher, she has partnered with patients and families, and other stakeholders (pharmaceutical industry), has spoken at national meetings, and served on advisory boards of advocacy organizations.
Co-Investigators and members of the Outcomes That Matter Council (OTM)
Robert Akins, Ph.D. (Co-I and Senior Faculty Development Leader, OTM Council) is Principal Scientist and Director, Center for Pediatric Clinical Research and Development at Nemours/AIDHC. He is the DE site Senior Faculty Development Leader, and aims to build clinical research capacity in DE among senior and junior faculty and build their skills in clinical trial development and implementation. At AIDHC, Dr. Akins is also Program Director for Professional Development in the NIH-funded (U54 multi-institutional, Delaware Clinical and Translational Research (CTR-ACCEL DE IDeA program, and is Director of DE-INBRE Developmental Research Project Program. He is an R01 investigator and has more than 25 years of mentoring, administrative, regulatory, and scientific research experience in basic, preclinical, and clinical studies. Dr. Akins helps to develop and implement ISPCTN-specific programs, and augments the integration of ISPCTN efforts with the Professional Development activities of the Delaware-Clinical and Translational Research ACCEL Program and the Scientist Development Program.
Aaron Chidekel, M.D. (Co-I, OTM Council, Mentor to Junior Investigators) is a pediatric pulmonology and sleep medicine physician and clinical investigator with over 20 years of experience in basic and clinical science and is Professor of Pediatrics at Thomas Jefferson University. As a clinical investigator and Division Chief of Pulmonology and Sleep Medicine, he has designed and/or participated in numerous investigator-initiated and externally funded clinical trials ranging from simple retrospective analyses to complex multi-center interventional clinical trials. He is the site PI for the ISPCTN Vitamin D Supplementation in Children With Obesity-Related Asthma (VDORA) study. He also is a mentor to the junior investigators on the grant, Dr. Strang and Canter. He serves on the Outcomes That Matter Council and the ISPCTN Airways Diseases Working Group.
Lee Pachter, D.O. (Co-I, OTM Council) is Director, Mentorship and Professional Development at the Value Institute of Christiana Care Health System, co-leads the DE-CTR Community Engagement and Outreach Core, and is Professor of Pediatrics, and Director, Health Policy program, Jefferson College of Population Health at Thomas Jefferson University. His positions emphasize the importance of representing underserved populations of all backgrounds in research and improving community outreach. He has over 25 years’ experience conducting research in the areas of sociocultural determinants of health, child behavior and development, racism and discrimination, social adversity and stress, and minority child health care and is also Editor-in-Chief, Journal of Developmental & Behavioral Pediatrics. He serves on the Outcomes That Matter Council and the ISPCTN Positive Child Outcomes Working Group.
Thao-Ly Tam Phan, M.D., MPH (Co-I, OTM Council) is a Research Scientist at Nemours/AIDHC and is Associate Professor of Pediatrics at Thomas Jefferson University. She has collaborated with scientists across multiple disciplines and multiple institutions about the psychosocial factors that contribute to disparities in pediatric obesity outcomes. She has developed and tested interventions to address these psychosocial factors, using patient-centered and innovative methodology. Dr. Phan serves as the DE Nemours/AIDHC site PI for the study “Feasibility of the iAmHealthy Intervention for Healthy Weight in Rural Children Recruited from Primary Care Clinics” and is a member of the Vitamin D in Pediatric Obesity-Related Asthma Writing Group, providing input on these ISPCTN activities from the perspective of an expert in pediatric obesity. She serves as co-Chair of the ISPCTN Obesity Working Group and on the Outcomes That Matter Council.
David Paul, M.D. (Co-I, OTM Council) is Clinical Leader, Women and Children’s Service Line, ChristianaCare Health System (CCHS) and is Professor of Pediatrics at Thomas Jefferson University. He has the expertise and track record to complete multicenter collaborative research with an established record of completing population health, disparities and epidemiologic investigations. ChristianaCare has is a regional perinatal referral hospital in DE with >6000 births/year and 1100 NICU admissions/year. The site had 200 babies with NOWS in the ISPCTN Neonatal Opioid Withdrawal Syndrome Current Experience (ACT NOWS CE) Protocol and was one of the top enrolling sites in the trial. He is also experienced in using State level data to investigate maternal child outcomes and including premature birth and infant mortality. He is the DE site PI for the “Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach” study, serves as co-Chair of the Peri-, Pre-, and Postnatal Outcomes ISPCTN Working Group and participates in the Outcomes That Matter Council.
Chijioke Ikomi, M.D.(OTM Council) is an expert in prevention and treatment of children with obesity and type 2 diabetes at AIDHC and is Clinical Assistant Professor of Pediatrics at Thomas Jefferson University. Her role in the ISPCTN includes engaging pediatricians, junior investigators and staff in the ISPCTN clinical trials in the area of obesity, and she helps our site to reach and recruit rural and underserved children in DE. She serves on the DE AIDHC site’s Outcomes That Matter Council.
Marisa Meyer, D.O. (OTM Council) is a Pediatric Intensivist at AIDHC, has an extensive background in Pediatric Critical Care Medicine, Extracorporeal Membrane Oxygenation, and Critical Care Transport Medicine, and is Clinical Assistant Professor of Pediatrics at Thomas Jefferson University. She has served as site PI on several NIH funded studies under the Pediatric Trials Network examining the pharmacokinetics, pharmacodynamics, and safety profile of many understudied drugs in pediatrics. She serves on the Outcomes That Matters Council and is a member of the POPS subcommittee.
Kevin P. Sheahan M.D. (OTM Council) is Chief, Nemours duPont Pediatrics, Delaware and is Medical Director of 11 primary care practices affiliated with Nemours in Delaware, which are part of the Nemours Value Based Services Organization. He is responsible for supporting research opportunities in primary care in DE, engaging pediatricians, junior investigators and staff in the ISPCTN clinical trials, and helps our site to reach and recruit rural and underserved children in DE. He serves on the Outcomes That Matter Council.
Kimberly Canter, Ph.D. (Junior Investigator, OTM Council) is a Pediatric Psychologist and Assistant Research Scientist II in the Center for Healthcare Delivery Science at Nemours/AIDHC and is Assistant Professor of Pediatrics at Thomas Jefferson University. Her research interests include developing and implementing evidence-based psychosocial interventions to decrease traumatic medical stress and improve coping skills and health outcomes for children with chronic illnesses and their families. She is the embedded psychologist in the Cystic Fibrosis Center at Nemours/AIDHC, working closely with a multidisciplinary team to provide clinical care and conduct quality improvement and research initiatives, and is PI on a behavioral sleep intervention study funded by the Cystic Fibrosis Foundation.Together with Dr. Strang, Dr. Canter will be working on a pilot study “Sleep Better, Breathe Better” for consideration of the ISPCTN’s Clinical Trial Project RFA and serves on the OTM Council.
Linhda Nguyen, PA-C, MHS has been a physician assistant in Healthy Weight and Wellness Clinic at Nemours Children's Health, Delaware since 2014 . Her interests include adolescent bariatric medicine, telemedicine, clinical research, and quality improvement.
Abigail Strang, M.D. (Junior Investigator, OTM Council) is a pediatric pulmonologist and pediatric sleep medicine physician at Nemours/AIDHC and is Assistant Professor of Pediatrics, Thomas Jefferson University. She completed pediatric residency and fellowship in pediatric pulmonology as well as an additional one-year fellowship in sleep medicine. Her clinical research is related to the relationship between sleep and physical and mental health in children with chronic respiratory diseases such as asthma and cystic fibrosis. Her prior research work and clinical training, collaboration with Dr. Canter, and mentorship from Dr. Chidekel (Co-I and mentor) provides a strong set of skills and supports which will enable her to excel in proposing, implementing, and completing an ISPCTN clinical trial project. Together with Dr. Canter, Dr. Strang will be working on a pilot study “Sleep Better, Breathe Better” for consideration of the ISPCTN’s Clinical Trial Project RFA and will serve on the OTM Council.
Nicole DiVirgilio, Clinical Research Coordinator with Nemours Children's Health. She received her M.S. in Health Promotion from the University of Delaware. She works on other research projects with a focus on sex chromosome variations and growth hormone deficiency in children. Her past research experience includes physical activity and nutrition policies within child care centers and fruit and vegetable prescription programs for families.
Karen Kowal, Physician’s Assistant and Research Coordinator I received my BS and PA degrees from Rutgers University in NJ. I am also a certified diabetes educator. I have been in pediatrics since starting my career in 1979. I have been with Dr. Judith Ross for over 30 years working in her pediatric endocrinology and research practices. Our research has involved diabetes, growth and chromosomal disorders in children. I have been honored to be included on the ECHO research team where I serve in a supervisory capacity of several coordinators. The opportunity to meet other coordinators and work towards a common goal of reaching rural children has been very gratifying.
Kimberly Renner, Clinical Research Nurse I am the Clinical Research Nurse with the Department of Pulmonology at Nemours and I work as the study coordinator for the VDORA trial. I graduated from Drexel University with my Bachelors in Nursing in 2009 and earned a Masters in Nursing from the University of West Georgia in 2017. I was born and raised in Bucks County, Pennsylvania and currently live in Wilmington, Delaware. I enjoy spending time with my husband, Nick, chasing after my toddler, Isaac, and taking naps with my retired racing greyhound, Dahlia.
Victoria Reynolds, Clinical Research Assistant I am a Clinical Research Assistant for Nemours. I have a Bachelor of Science in Health Behavior Science and a certificate in Clinical Trials Management from the University of Delaware. I currently work on the Feasibility Trial of the iAmHealthy Intervention for Healthy Weight in Rural Children Recruited from Primary Care Clinics where I recruit, enroll, and regularly engage with study participants. I am interested in research because there is always an opportunity to learn something new, and further my education.
Lisa M. Brown, Clinical Pharmacy Specialist I received my PharmD from Rutgers College of Pharmacy and a certificate of Pharmacogenomics from the University of Florida. I have managed all investigational drug product studies and participated as a voting IRB member since 2008 for Nemours Wilmington DE. In addition to the 90+ research studies that I handle on a full time basis, I championed our Pharmacogenomics Monitoring Program implementation at Nemours over the last three years. I am currently engaged in the NIH-funded Delaware Nemours/duPont Hospital for Children IDeA States Pediatric Clinical Trials Network for the Environmental Influences on Child Health Outcomes (ECHO) national initiative as the investigational pharmacist for the VDORA trial looking at the effect of vitamin D on children with asthma and obesity”.
Shidie “Violet” Tang, Investigational Drug Services Pharmacist I am an IDS pharmacist at Nemours Wilmington DE. I graduated with a PharmD and MPH from the University of Kentucky in 2015 followed by a one year Pharmacy Residency at Thomas Jefferson University Hospital, Philadelphia PA. Since then I worked as a clinical pharmacist on General Pediatrics and Hematology/Oncology services at Nemours for 4 years before joining the Investigational Drug Service in July 2020. It brings me great joy to work within multidisciplinary teams in clinical research and be part of the effort to bring cutting edge knowledge to direct patient care. I am actively engaged in the NIH-funded ECHO studies such as VDORA1 as an investigational pharmacist responsible for study drug procurement, storage, dispensing and accountability.