The University of New Mexico proposes to continue to work vigorously toward achieving the NICHD Neonatal Research Network 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 Co-PI, Robin Ohls, have extensive experience in designing and implementing clinical studies, both independently and within the Network, and provide significant intellectual contributions to the NRN. Dr. Watterberg is PI for the ongoing RCT of hydrocortisone to treat BPD (and vice-chair for its secondary study of cardiac function), Co-PI for the ongoing RCT of hydrocortisone for cardiovascular insufficiency in term and late preterm infants, and vice-chair of the subcommittee for the ongoing RCT of inositol to prevent retinopathy of prematurity. In 2013 she was awarded an R01 by NHLBI (HL117764) to study Adrenal Function and Cardiovascular Outcomes at Age 6 after Extremely Preterm Birth in children enrolled in the SUPPORT school-age follow up study. She serves on the Protocol Review Subcommittee and is Co-PI for an approved study of sodium and diuretics in preterm infants. Dr. Ohls is PI for a Steering Committee approved RCT of darbepoetin for neuroprotection in preterm infants and is Co-PI for another approved RCT, the Hypothermia plus Epo (HOPE) study. She also serves on protocol subcommittees for the RCTs of transfusion thresholds in preterm infants and laparotomy vs drain for NEC. Jean Lowe, the follow up PI, is also PI of an ancillary study assessing the correlation of working memory at 18 - 22 months with executive function at school age, and is one of two gold standard Spanish examiners for the SUPPORT school-age follow up study. Additional strengths include large under-represented Hispanic and Native American populations (56% and 24% of UNM generic database patients and 48% and 25% of RCT enrollment for the current funding cycle, compared to 14% and <1% for the overall NRN in 2013); a comprehensive Developmental Care and follow-up program resulting in a Neurodevelopmental Follow-up rate of 90% (March 2015 NRN summary report); a statewide outreach and transport system resulting in >85% of VLBW infants being inborn; ongoing collaboration with the MIND Research Network which can provide a unique imaging resource for future NRN studies; and an NIH-funded Clinical and Translational Science Center. The expertise and experience of the investigators, together with the facilities, programs, and patient populations at UNM, make UNM a unique and worthy continuing contributor to the Neonatal Research Network.
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 member of the Network, and we propose to continue our enthusiastic participation during the next funding cycle.
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