Neonatal-Perinatal Research Unit
Dedicated to improving the outcomes of our babies.
The Neonatal Perinatal Research Unit (NPRU) explores causes, preventative measures, and treatments for many of the major negative health outcomes that impact premature and full-term infants. Our research is focused on both improving the care that we provide to these newborns and continuing to explore new therapies and treatment options.
How you can help
Our mission is to provide the professional infrastructure and clinical expertise directed toward improving the quality of care and long-term outcomes for our babies. Find out how you can help support our babies and our research.
How you can participate
If you currently have a baby in the Duke Intensive Care Nursery, and you think you may want to participate in any of our research studies, please ask your baby’s nurse or doctor to contact us. The NPRU team will then contact you to explain the criteria for study eligibility and describe the potential benefits and risks for entering the study. Learn about our current research opportunities.
Over the past 20 years, Duke researchers have worked to understand the special biologic restorative properties of progenitor and stem cells collected from umbilical cord blood. Duke has used cord blood for infants born with signs of brain injury caused by lack of adequate blood flow and oxygen delivery. Duke completed phase I in 2016, enrolling more than 50 babies born with hypoxic-ischemic encephalopathy (HIE). Results from the first 23 infants were published in 2014 in the Journal of Pediatrics. Phase II was a randomized placebo-controlled trial of cells for neonatal brain injury at 11 additional centers across the country. A challenge to generalizability of these clinical trials, and potential use of autologous (the baby’s own) cord blood cells is that approximately two-thirds of infants born with neonatal brain injury do not have cells available. Duke has developed human cord tissue-derived mesenchymal stromal cells from umbilical cord tissue donated by third party donors and is testing these cells as an investigational product under the guidance of the Federal Drug Agency (FDA) in children. This product allows for a readily available ‘off-the-shelf’ cellular intervention product for neonatal brain injury. Duke has been funded by the Duke Clinical & Translational Science Institute (CTSI) to demonstrate the safety of infusion of these cells in a small cohort of newborns both with hypoxic-ischemic encephalopathy. Enrollment for this trial was completed in July of 2019, currently follow-up is ongoing.
In the spring of 2017 Eunice Kennedy Shriver National Institute of Child Health and Human Development, Neonatal Research Network, an institute of the National Institutes of Health (NIH), awarded Duke University our fourth consecutive competitive renewal for the Neonatal Research Network. The mission of the NRN is to conduct clinical trials and observational studies in neonatal medicine in order to reduce morbidity and mortality and promote healthy outcomes for our babies. We are proud to be a member of this prestigious organization.
The following are some of the sources of research funding for the Neonatal Perinatal Research Unit (NPRU):
- Baebies, Inc.
- Basilea Pharmaceutica International Ltd.
- Center for Disease Control and Prevention (CDC)
- Center for Disease Control and Prevention Clinical Immunizations Safety Assessment (CISA) Project
- Clinical & Translational Science Institute (CTSI)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development, Neonatal Research Network
- Infant Bacterial Therapeutics AB (IBT)
- Mallinckrodt, Inc.
- National Institutes of Health
- National Institutes of Health (through Vanderbilt University)
- National Institutes of Health (through University of South Carolina)
- National Palliative Care Research Center
- Patient-Centered Outcomes Research Institute (POCORI)
- Pediatric Epilepsy Research Foundation (PERF)
- Duke Clinical Research Institute (DCRI)
- Translating Duke Health Children’s Health Initiative (TDHI)
We believe that a significant part of doing our best for babies in the intensive care unit is working hard to identify the best, safest and most effective ways to provide care. To do this, Duke is proud to participate in multiple research studies.
C. Michael Cotten, MD, MHS, Chief of the Division of Neonatology
To learn more about the Duke Intensive Care Nursery, visit the Duke Division of Neonatology website. For more information about the Neonatal Perinatal Research Unit or to learn more about our clinical trials, email us at email@example.com, or call 919-681-4913.