The University of New Mexico proposes to continue to help the NICHD Neonatal Research Network achieve its primary objective of advancing the field of Neonatal-Perinatal Medicine through a network of academic centers performing rigorous, multi-center clinical protocols to investigate the safety and efficacy of treatment and management strategies for newborn infants. UNM has shown its commitment to all facets of the Network mission. The PI, Kristi Watterberg, and Alternate PI, Robin Ohls, have extensive experience in designing and implementing clinical studies, both independently and within the Network. Dr. Watterberg is PI for a planned RCT of hydrocortisone to treat BPD (approved by the NRN advisory board), serves on the Protocol Review Subcommittee which provides critical peer review for Network studies, is Vice-Chair of two protocol subcommittees, and has brought additional investigators and protocols to the Network. Dr. Ohls serves on protocol subcommittees, participates in protocol development, and continues her independent research, including a multicenter RCT of erythropoiesis-stimulating agents (PI) with NIH-funded neurodevelopmental outcomes assessments. Additional UNM investigators include Erika Fernandez (Supplemental Award) who developed a protocol, """"""""Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants,"""""""" has completed the first, observational, phase and is planning the second phase, an RCT. Andrea Duncan and Jean Lowe are conducting an ancillary study to assess the correlation of working memory at 18-22 months with executive function at school age. Additional strengths include large under-represented Hispanic and Native American populations (53% and 22% of UNM enrollment in the generic database (GDB));a statewide outreach and transport system resulting in >85% of VLBW infants being inborn;a General Clinical Research Center Pediatric Scatterbed Program (directed by Dr. Ohls) now transitioning to a Clinical and Translational Science Center;and a comprehensive Developmental Care program, resulting in a GDB follow-up rate of 92%. The facilities, programs and patient populations at UNM, together with the expertise and experience of its investigators, make UNM a worthy continuing contributor to the Neonatal Research Network.

Public Health Relevance

Advancement of evidence-based best health care practices requires the performance of large, well-done clinical trials. Newborn Intensive Care Units do not have enough patients to accomplish this individually;therefore, NIH developed a Neonatal Research Network of academic centers to advance health care for sick infants by performing rigorous multi-center clinical studies. The University of New Mexico has been a highly productive Network contributor and proposes to continue its participation during the next funding cycle.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10HD053089-08
Application #
8452597
Study Section
Special Emphasis Panel (ZHD1-DSR-A (03))
Program Officer
Raju, Tonse N
Project Start
2006-04-01
Project End
2016-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
8
Fiscal Year
2013
Total Cost
$279,376
Indirect Cost
$94,359
Name
University of New Mexico Health Sciences Center
Department
Pediatrics
Type
Schools of Medicine
DUNS #
829868723
City
Albuquerque
State
NM
Country
United States
Zip Code
87131
Weissman, Scott J; Hansen, Nellie I; Zaterka-Baxter, Kristen et al. (2016) Emergence of Antibiotic Resistance-Associated Clones Among Escherichia coli Recovered From Newborns With Early-Onset Sepsis and Meningitis in the United States, 2008-2009. J Pediatric Infect Dis Soc 5:269-76
Wortham, Jonathan M; Hansen, Nellie I; Schrag, Stephanie J et al. (2016) Chorioamnionitis and Culture-Confirmed, Early-Onset Neonatal Infections. Pediatrics 137:
Phelps, Dale L; Ward, Robert M; Williams, Rick L et al. (2016) Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants. Pediatr Res 80:209-17
Meyers, J M; Bann, C M; Stoll, B J et al. (2016) Neurodevelopmental outcomes in postnatal growth-restricted preterm infants with postnatal head-sparing. J Perinatol 36:1116-1121
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
Ambalavanan, Namasivayam; Carlo, Waldemar A; Wrage, Lisa A et al. (2015) PaCO2 in surfactant, positive pressure, and oxygenation randomised trial (SUPPORT). Arch Dis Child Fetal Neonatal Ed 100:F145-9
Fernandez, Erika; Watterberg, Kristi L; Faix, Roger G et al. (2015) Definitions of cardiovascular insufficiency and relation to outcomes in critically ill newborn infants. Am J Perinatol 32:1024-30
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

Showing the most recent 10 out of 64 publications