1) Neuroprotection. Working with colleagues from Cell Therapies, we have added to Duke's experience participating in pivotal trials of hypothermia for term newborns with moderate to severe hypoxic-ischemic encephalopathy (HIE) by completing a phase I study of autologous cord blood cells for these infants, and developing and currently leading a multicenter, double-blind randomized clinical trial of autologous cord blood cells or placebo in term infants with moderate or severe HIE. We are currently initiating, w/ funding from Duke's CTSI support, the first phase I single center study of allogeneic cord tissue derived mesenchymal stromal cells for newborns with moderate or severe HIE who do not have autologous cells available.
2) Genomics. We at Duke have been in the NICHD Neonatal Research Network (NRN) since 2001. I led the NRN's development of an Anonymized DNA bank of samples collected from 1,000 extremely low birthweight infants, with phenotype information linked to the samples. This resource has been the basis for multiple candidate gene, and genome wide scan analysis, and has identified variants associated with severe retinopathy of prematurity and necrotizing enterocolitis.
3) New Technologies: I have collaborated with Drs. David Millington from Duke and Vamsee Pamula (a Duke Pratt School graduate), from BAEBIES Inc, on prototype new technology devices for use in newborn screening for lysosomal storage disease as well as multiplex chips for screening for hyperbilirubinemia and related conditions, as well as working with Dr. Pamula and Dr. Michael Freemark (Peds Endocrinology) on screening panels for hypoglycemia and hypothyroidism, and with investigators from UAB on an Acute Kidney Injury panel. Also, I am collaborating with Dr. Cynthia Toth in pediatric ophthalmology, and Pratt School investigators to develop and apply use of optical coherence tomography for retinal imaging that will assess associations between retinal neurovascular development, brain development, and neurodevelopmental outcomes. I am also currently working with the Duke FORGE and multiple Pediatric subspecialists on machine-learning and deep informatics analysis of electronic health records to quantify risk for subsequent complications and on development of algorithms to identify neonatal seizures from neonatal EEG tracings.
4)Microbiome in Micropreemies and health outcomes of periviable infants. I have worked with multiple epidemiology researchers to assess practice variation within our center, and within the Neonatal Research Network centers, to identify how variation in practice can influence outcomes, with a particular focus on antibiotic use. This work demonstrated strong associations between high empirical antibiotic use in infants with sterile cultures and subsequent morbidities and mortality. This discovery has led to strong collaborations and new initiatives by young faculty leading studies of the evolving microbiome, leading to hypothesis generation re: the microbiome and optimal growth in extremely preterm infants.
