The Division of Neonatology of Nationwide Children's Hospital and The Ohio State University submits this application to join the Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal Research Network in response to RFA-HD-10-003. Strengths of our Institution include: 1) a truly academic Division that consists of 19 clinical faculty members with an exceptional record of clinical research, 2) a large and medically diverse population available for clinical studies with 2,197 NICU admissions in 2009 of which 615 were <= 32 weeks gestational age and 539 were <1500 grams birthweight, 3) a vibrant collaborative relationship with maternal-fetal medicine and a long and successful relationship between our institution and the NICHD MFMU, 4) a dynamic Center for Perinatal Research housed in the Research Institute, which includes a vigorous clinical research enterprise the Ohio Perinatal Research Network, and 5) a robust Institutional commitment to preventing prematurity and its complications. Indeed, preventing prematurity is the focus of NCH's strategic plan. All of these strengths will contribute greatly to NICHD NRN studies. Furthermore, our population is very receptive and agreeable to participation in clinical studies related to preterm birth. Our clinical capabilities are far reaching and include essentially every service offered to preterm neonates. We have a neonatal follow-up program that has proven to be particularly well suited to follow-up of subjects in clinical protocols. Our concept application entitled, """"""""Developing a Personalized Medicine Approach to Preterm Infants"""""""", brings together neonatology, genetics, mathematical medicine, and biostatistics to develop a personalized medicine approach to the complications of prematurity. This concept application demonstrates our expertise in acquiring, storing and analyzing vast data sets. This expertise will be necessary for any """"""""omic"""""""" types of studies that the NICHD NRN may undertake in the years to come. Our assets, abundant clinical material, outstanding institutional support, exceptional collegiality between MFM and neonatology, the resources of a dedicated pediatric research institute, and outstanding academic neonatologists make NCH/OSU an ideal site for the NICHD NRN.
The burden to the American health care system of prematurity is immense, responsible for ~67% of all infant deaths and health care costs of $26 billion a year. Collaborative efforts to gather high quality evidence to prevent and improve the adverse outcomes of prematurity are desperately needed, and the NICHD Neonatal Research Network is the foremost mechanism for gathering such high quality neonatal evidence.
|Archer, Stephanie Wilson; Carlo, Waldemar A; Truog, William E et al. (2016) Improving publication rates in a collaborative clinical trials research network. Semin Perinatol 40:410-417|
|Pedroza, Claudia; Tyson, Jon E; Das, Abhik et al. (2016) Advantages of Bayesian monitoring methods in deciding whether and when to stop a clinical trial: an example of a neonatal cooling trial. Trials 17:335|
|Foglia, Elizabeth E; Nolen, Tracy L; DeMauro, Sara B et al. (2015) Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled. JAMA 313:2377-9|
|Stoll, Barbara J; Hansen, Nellie I; Bell, Edward F et al. (2015) Trends in Care Practices, Morbidity, and Mortality of Extremely Preterm Neonates, 1993-2012. JAMA 314:1039-51|
|Patel, Ravi M; Kandefer, Sarah; Walsh, Michele C et al. (2015) Causes and timing of death in extremely premature infants from 2000 through 2011. N Engl J Med 372:331-40|
|Fernandez, Erika; Watterberg, Kristi L; Faix, Roger G et al. (2014) Incidence, management, and outcomes of cardiovascular insufficiency in critically ill term and late preterm newborn infants. Am J Perinatol 31:947-56|
|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|
|Sood, Beena G; Keszler, Martin; Garg, Meena et al. (2014) Inhaled PGE1 in neonates with hypoxemic respiratory failure: two pilot feasibility randomized clinical trials. Trials 15:486|
|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|
|Payne, Allison H; Hintz, Susan R; Hibbs, Anna Maria et al. (2013) Neurodevelopmental outcomes of extremely low-gestational-age neonates with low-grade periventricular-intraventricular hemorrhage. JAMA Pediatr 167:451-9|
Showing the most recent 10 out of 13 publications