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.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Cooperative Clinical Research--Cooperative Agreements (U10)
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Special Emphasis Panel (ZHD1-DSR-A (03))
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Raju, Tonse N
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University of New Mexico Health Sciences Center
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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
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Pappas, Athina; Kendrick, Douglas E; Shankaran, Seetha et al. (2014) Chorioamnionitis and early childhood outcomes among extremely low-gestational-age neonates. JAMA Pediatr 168:137-47
Kelleher, John; Salas, Ariel A; Bhat, Ramachandra et al. (2014) Prophylactic indomethacin and intestinal perforation in extremely low birth weight infants. Pediatrics 134:e1369-77
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Randolph, David A; Nolen, Tracy L; Ambalavanan, Namasivayam et al. (2014) Outcomes of extremely low birthweight infants with acidosis at birth. Arch Dis Child Fetal Neonatal Ed 99:F263-8

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