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Research

Neonatology

The Section of Neonatology has a long history of involvement in research activities. The majority of the studies are clinically related projects designed to investigate various aspects of the clinical care provided in the neonatal ICU. Members of the Division also participate in basic science research through collaboration with colleagues in other departments, both here at ECU and at other Institutions. Over the years, the Division has participated in several multicenter NIH funded trials, as well as industry sponsored studies. We are also fortunate to have the services of a full-time research nurse and several part-time research study coordinators to help support research activities within the Division.

Open Clinical Trials

Study to Compare CHF 5633 (Synthetic Surfactant) and Poractant Alfa in RDS
A multicenter, double blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of synthetic surfactant (CHF 5633) in comparison to porcine surfactant (Poractant alfa, Curosurf ®) in the treatment of preterm neonates with respiratory distress syndrome.

Vermont Oxford Network - The Extremely Low Birth Weight Infant Follow-up Project
A multi-center study involving member centers of the Vermont Oxford Network. To obtain health and developmental outcomes of surviving neonates with birth weights of 400-1000g or gestational age at birth between 22 - 28 weeks.

ELGAN 3: Environment, Epigenetics, Neurodevelopment & Health of Extremely Preterm Children
The third phase of a multi-centered, prospective, longitudinal study of preterm neonates. This phase of the study aims to understand learning, communication and social skills of teenagers who were born very early.

Prevention of Transfusion Related Acute Gut Injury (TRAGI) in Extremely Low Gestational Age Neonates (ELGANs) Using iNO (iNO-TRAGI)
A multi-centered, prospective trial to determine whether providing inhaled nitric oxide (iNO; a vasodilator) will improve the delivery of oxygen to the brain, kidney and intestines of preterm neonates during and after the subject receives a packed red blood cell transfusion (PRBC) for anemia.

Trial to Assess the Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
A multicenter, multinational, randomized, masked (double-blind), and controlled trial to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Resipiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.

The Association Between Pregnancy Exposures with Fetal Metabolites and Neonatal Outcomes
A single-center, prospective case-control study of pregnancy exposures (primarily illicit drugs) and neonatal outcomes. We intend to explore the impact of exposures on fetal metabolites and the interaction of the metabolites on neonatal outcomes.

Study to Assess the Efficacy and Safety of NTRA-2112 on Intestinal Malabsorption in Preterm Infants
A randomized, blinded study to evaluate the safety and efficacy of NTRA-2112 given to premature infants on intestinal malabsorption (as defined by time to full feeds). The study will enroll preterm infants weighing at least 500g born between 26 and up to 32 weeks at the time of delivery.

Validation of a Modified Early Neonatal Discharge Assessment Tool
A comparison of discharge risk stratification in infants tested with both the modified early neonatal discharge assessment tool and the traditional neonatal discharge assessment tool.

Clinical Validation of SunTech Advantage 2 with Neonate Cuff Line against Invasive Intra-Arterial Reference
A study to evaluate the performance and accuracy of SunTech Medical's blood pressure monitoring technologies, monitors and/or accessories in neonatal and pediatric patients under the age of 3 years.

Determining the Prevalence of Hypertension in the NICU with Implementation of Standardized Guidelines for Blood Pressure Measurements and Diagnosis
A study to determine the true prevalence of neonatal hypertension by collecting data after implementation of new standard of care guidelines for blood pressure measurement. Data will be collected on neonates with a single elevated blood pressure

Selected Publications

Ravisankar S, Kuehn D, Clark RH, Greenberg RG, Smith PB, Hornik CP. Antihypertensive drug exposure in premature infants from 1997 to 2013. Cardiol Young. October 2016:1-7.

Belfort MB, Kuban KCK, O'Shea TM, et al. Weight Status in the First 2 Years of Life and Neurodevelopmental Impairment in Extremely Low Gestational Age Newborns. J Pediatr. 2016;168:30-5.e32.

Garg PM, Tatum R, Ravisankar S, Shekhawat PS, Chen Y-H. Necrotizing enterocolitis in a mouse model leads to widespread renal inflammation, acute kidney injury, and disruption of renal tight junction proteins. Pediatr Res. 2015;78(5):527-532.

Garg PM, Ravisankar S, Bian H, Macgilvray S, Shekhawat PS. Relationship between Packed Red Blood Cell Transfusion and Severe Form of Necrotizing Enterocolitis: A Case Control Study. Indian Pediatr. 2015;52(12):1041-1045.

Korzeniewski SJ, Allred E, Logan JW, et al. Elevated endogenous erythropoietin concentrations are associated with increased risk of brain damage in extremely preterm neonates. PLoS ONE. 2015;10(3):e0115083.

Lozada LE, Nylund CM, Gorman GH, Hisle-Gorman E, Erdie-Lalena CR, Kuehn D. Association of Autism Spectrum Disorders With Neonatal Hyperbilirubinemia. Global Pediatric. 2015.

Logan JW, Allred EN, Fichorova RN, et al. Endogenous erythropoietin varies significantly with inflammation-related proteins in extremely premature newborns. Cytokine. 2014;69(1):22-28.

Dobson NR, Patel RM, Smith PB, et al. Trends in Caffeine Use and Association between Clinical Outcomes and Timing of Therapy in Very Low Birth Weight Infants. J Pediatr. January 2014.

Ravisankar S, Syed SS, Garg P, Higginson J. Is Cronobacter sakazakii infection possible in an exclusively breastfed premature neonate in the neonatal intensive care unit? J Perinatol. 2014;34(5):408-409.

Leviton A, Allred EN, Dammann O, et al. Systemic inflammation, intraventricular hemorrhage, and white matter injury. J Child Neurol. 2013;28(12):1637-1645.

Dobson NR, Moore RT, Tobin JE, Armstrong RC. Leukemia/lymphoma-related factor regulates oligodendrocyte lineage cell differentiation in developing white matter. Glia. 2012;60(9):1378-1390.

Logan JW, O'Shea TM, Allred EN, et al. Early postnatal hypotension and developmental delay at 24 months of age among extremely low gestational age newborns. Arch Dis Child Fetal Neonatal Ed. 2011;96(5):F321-F328.

Venkataraman A, Kingsley PB, Kalina P, et al. Newborn brain infarction: clinical aspects and magnetic resonance imaging. CNS Spectr. 2004;9(6):436-444.

Harper RG, Rehman KU, Sia C, et al. Neonatal outcome of infants born at 500 to 800 grams from 1990 through 1998 in a tertiary care center. J Perinatol. 2002;22(7):555-562.