This application, submitted in response RFA HD-10-003, seeks to achieve inclusion of the Children's Mercy Hospitals and Clinics, Truman Medical Center, and University of Missouri-Kansas City School of Medicine-unified Perinatal Center in the 2011-2016 version of the Eunice Kennedy Shriver NICHD Neonatal Research Network. Our Center brings substantial experience in all levels of Phase I, Phase II and Phase III clinical trials as well as other designs including crossover trials. Through our faculty's longstanding affiliation with the Vermont Oxford Network (VON), and more recent leadership In the CHNC NICU database program, we bring substantial experience in cooperative Investigative activities. The overall GOAL of our unified Perinatal Center is to improve the outcomes of high-risk preterm and term infants. We demonstrate in our application our ability to manage comprehensive and long-term follow-up programs. We provide evidence of studies conducted successfully in an ethnically diverse patient population. We also provide, as requested in the RFA, an outline for a hypothetical trial utilizing an equivalence model for testing a reduced dose against a "standard" dose of inhaled nitric oxide assessing cost effectiveness of very low birthweight infants at high risk of developing bronchopulmonary dysplasia.
The SPECIFIC AIMS of this application are to provide responses to the RFA with detail with data to demonstrate that our center exceeds the requirements specified;to describe a hypothetical clinical trial;and to demonstrate multiple unique or unusual features that would make positive contributions to the next version of the network. Our long-term goal is to harness and leverage our local expertise and population to reduce suffering and death in high-risk infants.
The NRN will utilize the powerful tool of multi-center clinical trials to establish the safety and efficacy of potentially important new therapies for at risk infants with the ultimate goal of reducing mortality and thereby also improving life expectancy at birth in the US. Our Center can contribute our large population of ethnically diverse at risk infants, making the study results more widely acceptable and applicable.
|DeMauro, Sara B; D'Agostino, Jo Ann; Bann, Carla et al. (2014) Developmental outcomes of very preterm infants with tracheostomies. J Pediatr 164:1303-10.e2|
|Shankaran, Seetha; Laptook, Abbot R; Pappas, Athina et al. (2014) Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial. JAMA 312:2629-39|