The fellow is a part of the clinical research team in the division and is expected to develop his/her own questions that can serve as a testable hypothesis. Clinical research opportunities in this area include: a) NICHD Neonatal Network (Ronald Goldberg, M.D.) b) Randomized Trial of a Benchmarking Intervention to Increase Survival with BPD c) Induced Hypothermia (body cooling) for Encephalopathy and Aggressive Versus Conservative Phototherapy for the Extremely Low Birthweight Infant. Additional clinical research opportunities exist as well in clinical database access and neurodevelopmental outcomes.

 

 

Daniel K. Benjamin, Jr., M.D., MPH, Ph.D., Associate Professor of Pediatrics
Dr. Benjamin’s interests include nosocomial neonatal bacteremia and candidemia. He is the National Principal Investigator for a multi-center trial of new tools to diagnose neonatal candidiasis, and two multi-center trials for drug trials for pediatric indication. He is also the Principal Investigator and Protocol Chair for several multi-center studies to investigate the pharmacokinetics of antimicrobial agents in premature infants

Debra Brandon, PhD, RN, CCNS is an Associate Professor in the School of Nursing and in the Department of Pediatrics of the School of Medicine with expertise in longitudinal neonatal clinical research. She joined the faculty of Duke University School of Nursing in the October of 1999 and has practiced as the Neonatal Clinical Nurse Specialist for the Duke Hospital Intensive Care Nursery since September of 1994. Dr. Brandon’s research focuses on the health and development of high-risk infants and young children with an overall goal of improving the short- and long-term outcomes of high-risk preterm infants and their families. Dr. Brandon has conducted two longitudinal studies with preterm infants (F-31 NR07180; R01 NR008044), which compared the effects of day-night cycling of light to continuous near darkness in preterm infants using a randomized longitudinal design. Dr. Brandon was also co-investigator on an RO1 evaluating the relationship between preterm infant sleep and their long-term outcomes (R29 NR01894, D. Holditch-Davis, PI). These studies have led to her expertise in infant sleep and the development of a new instrumented measure of sleep-wake assessment. Dr. Brandon has recently completed two pilot studies evaluating palliative and end-of-life care for infants and children with life-threatening conditions and is currently Co-PI on a study examining decision-making for infants with complex life-threatening conditions (1R01NR010548-0, Docherty). Dr. Brandon also has expertise in the conduct of qualitative analysis.


Robert Califf, M.D., Associate Vice Chancellor for Clinical Research, Director of the Duke Clinical and Translational Research Institute, Professor of Medicine

Dr. Califf has particular research interests in the methods and infrastructure of clinical and translational research. Within his medical specialty of cardiology, he has focused on clinical trials in acute coronary syndromes, heart failure and secondary prevention. The DCRI offers a wide variety of clinical research tools and training as part of its mission of providing translational and clinical research. Dr. Califf coordinates and directs the ongoing clinical research and clinical trials as well as being involved with development of novel trial formats and analysis techniques. Two junior faculty members of the Division are being mentored by Dr. Califf (Dr's. Michael Cotten and Daniel Benjamin).

C. Michael Cotten, M.D., Assistant Professor of Pediatrics Neonatology

Dr Cotten is the Director of Neonatal Clinical Research at Duke. He is the alternate site Principle Investigator for the NICHD Neonatal Research Network, and is the Director of the Special Care Nursery at Durham Regional Hospital. His research focuses on variation in individual infants' risks of complex diseases of prematurity. His work has involved assessment of center differences in risk of morbidities and mortality in high risk infants. With Network and Duke colleagues, he and Dr. Goldberg have received NICHD funds to develop a DNA repository for the Network's extremely low birthweight infants at the Duke Center for Human Genetics. This resource will allow large scale genetic association studies in high risk premature infants. He serves on the NICHD Neonatal Network's Genomics Subcommittee. He has completed a Master's Degree in Clinical Research at the DCRI and serves on the Duke IRB.

Ronald N. Goldberg, M.D., Professor of Pediatrics, Director of Neonatology

Dr. Goldberg’s interests include the cardiovascular manifestations of sepsis and septic shock in the neonate. In addition, he has been involved in clinical research and Multicenter Collaboration involving nitric oxide, surfactant and high frequency ventilation. He is the PI representing Duke in the NICHD Neonatal Research Network and has been a recipient, along with Dr. Jonathan Stamler, of the Duke Translational Medicine Research Award. He has a major interest in the perinatal asphyxia and has developed a Phase I study evaluating autologous cord blood transfusions in these patients. In addition he is involved in developing the use of fluidics and nanotechnology as a point of care diagnostic tool.

Ricki F. Goldstein, M.D., Assistant Professor of Pediatrics, Associate

Dr. Goldstein’s research interest is in neurodevelopmental follow-up of high-risk infants with a particular emphasis on long-term outcome of extremely low birth-weight premature infants and full term infants treated with extracorporeal membrane oxygenation or high frequency ventilation for respiratory failure. She is studying clinical predictors of outcome as well as genetic factors that affect susceptibility to brain and neurologic recovery after injury has occurred.
Dr. Goldstein's developmental group has also been involved in creating an educational program for well-child care providers and community interventionists concerning the post-discharge care of premature and other high-risk infants. She is also the follow-up PI to the NICHD Neonatal Network.

Diane Holditch-Davis, RN, Ph.D.

Dr. Holditch-Davis received her doctorate in developmental psychobiology at the University of Connecticut in 1985. She will join the faculty of the Duke University School of Nursing in January 2006. From 1985-2005, she was on the faculty of UNC-Chapel Hill. Dr. Holditch-Davis' research focuses on identifying risk for preventing long-term developmental and health problems in high-risk infants. She is currently principal investigator on an R01 testing the effectiveness of a nursing support intervention for rural, African-American mothers of preterm infants. The goal of this intervention is to reduce developmental delays by improving the mother's psychological well-being, improving the mother-infant relationship, and getting mothers to use early intervention and health services for their infants. She has been PI on 2 other NINR-funded studies examining how biological risk as measured by behavioral sleep-wake state development, EEG dysmaturity, visual attention, and perinatal neurological insults interact with social risk (quality of mother-infant interactions and the social environment) to result in developmental and health outcomes of preterms. She has utilized her expertise with observational methods to measure parent-child interactions as a co-investigator on multiple studies, including 2 studies testing an intervention to treat depressive symptoms in low-income Latina, African-American, and white mothers, a study of parental role attainment in parents of medically fragile infants, and a study of parental care giving of infants seropositive for HIV.

Jennifer Li, M.D., Pediatric Cardiology

Dr. Li is a graduate of Duke University School of Medicine and has been a member of the Duke faculty for 13 years. She is currently the Director of the Pediatric Clinical Research Initiative at the DCRI and has expertise in pediatric cardiology, cardiac imaging, and clinical trials. Under her direction, the DCRI has coordinated multiple NIH- and industry-sponsored pediatric projects in cardiology, infectious diseases, and neuro-psychiatry. She was the principal investigator for an industry-sponsored international, multi-center study to evaluate the safety and effectiveness of a range of fosinopril doses in the treatment of children with hypertension. She was the principal investigator for an industry-sponsored international multi-center study to evaluate the pharmacodynamics of clopidogrel in infants with cyanotic congenital heart disease and Blalock-Taussig shunts. Dr. Li is also a co-investigator for the North Carolina Consortium for the NIH-NHLBI Pediatric Heart Network. She has participated in several other multi-center clinical trials in pediatric cardiology including studies on TP10, amlodipine, and intra-cardiac devices. She has an appointment in the Office of the Commissioner at FDA to evaluate pediatric drug clinical trials. Because of her dedication and experience in pediatric clinical research and her leadership skills in the DCRI, Dr Li is well-situated to mentor clinical research training.

William F. Malcolm, M.D., Associate Professor of Pediatrics

 

Dr. Malcolm is Associate Professor of Pediatrics. He joined the faculty in 2002. He provides clinical care in the Intermediate Transitional Care Nursery. Dr. Malcolm's clinical interests include caring for the convalescent infant and medical and neurodevelopmental follow-up. He is the medical liaison for the developmental team. His research includes a 3 year study of GERD in VLBW newborns, (Gerber Foundation) in collaboration with Boston Children's Hospital Department of Pediatrics, Gastroenterology, he is using a multi-channel intraluminal impedance technique to accurately assess acid and non-acid reflux. Dr. Malcolm is investigating intraluminal impedance technique to accurately assess acid and non-acid reflux. Dr. Malcolm is investigating methods to prevent enteral feeding failures in infants with surgical NEC and short gut syndrome.

 

 

Dr. MacIntyre is interested in pulmonary gas exchange during acute and chronic lung disease and assessment of regional differences in pulmonary diffusing capacity. He is also interested in applications of high frequency jet ventilation to enhance gas exchange and/or decrease pulmonary barotrauma, determination of the effects of different types of mechanical ventilation on the work of breathing and weaning from mechanical ventilation.

Ross E. McKinney, M.D., Associate Professor of Pediatrics, Vice Dean for Research

 

 

Dr. McKinney is a long time member of the Pediatric AIDS Clinical Trials Group. He is also PI of the North Carolina Collaborative Center (Duke and UNC) in the NICHD funded Pediatric Pharmacology Research Unit Network. He is also a member of the Executive Committee of the PPRU Network.

Dr. McKinney began working with pediatric HIV infection in 1986 in a phase I clinical trial at Duke (in collaboration with the NCI and the University of Miami). The first child known to receive AZT (now Zidovudine) began his therapy at Duke. Our Pediatric Infectious Disease group was also the first to propose the trial to use maternal AZT treatment to prevent vertical transmission of HIV from mother to infant. Dr. McKinney and our division subsequently championed this study.

Courtney Thornburg, M.D., M.S. Assistant Professor of Pediatrics

Dr. Thornburg is trained in pediatric hematology/oncology and completed a National Hemophilia Foundation Clinical Fellowship in Pediatric Hemostasis and Thrombosis. Her primary clinical and research interests relate to pediatric hemostasis and thrombosis. Dr. Thornburg sees children for the evaluation of bleeding symptoms including easy bruising, epistaxis, menorrhagia, excessive bleeding after tooth extraction or surgery, and abnormal coagulation tests. She takes care of children with bleeding disorders such as hemophilia, von Willebrand disease, and platelet function defect and children. She also takes care of children with thrombosis including deep venous thrombosis, pulmonary embolus and sinovenous thrombosis, and evaluates children who are asymptomatic but have a family history of thrombosis or risk factor for thrombosis. Dr. Thornburg is part of the Hemostasis and Thrombosis Center at Duke University Medical Center. The Hemostasis & Thrombosis Center is participating in a multi-center project coordinated and funded by the Centers for Disease Control and Prevention (CDC). The purpose of this project is to characterize the types of patients referred to the Center. Data collected from this study will help us learn more about medical care and management for patients with bleeding and clotting disorders.

Dr. Thornburg 's research interests include outcomes related to maternal/fetal thrombosis and hemostasis, screening for prothrombotic risk factors, genetic modifiers of von Willebrand disease, and treatment adherence in patients with hemophilia and sickle cell anemia. In addition, Dr. Thornburg participates in the NIH sponsored Transfusion Medicine Hemostasis Clinical Trials Network.