The University of New Mexico proposes to join the NICHD Neonatal Research Network in working to achieve its primary objective of advancing the field of Neonatal-Perinatal Medicine through a network of academic centers that perform rigorous, multicenter clinical protocols to investigate the safety and efficacy of treatment and management strategies for newborn infants. The principal investigator, Kristi Watterberg, MD, and the alternate PI, Lu-Ann Papile, MD, have extensive experience in designing and carrying out both observational and interventional clinical studies. Specifically, Dr. Watterberg designed, received NICHD funding for, and directed all phases of a recent multicenter clinical trial of early, low-dose hydrocortisone therapy to prevent bronchopulmonary dysplasia. Now in its follow-up phase, this study generated important information regarding safety and efficacy of this therapy, critical to designing future studies. Dr. Papile was a NRN PI for 10 years and has a long history of both collaborating and acting as PI for clinical research studies, including several NRN studies. Specific strengths of the UNM program include (1) a neonatal division with broad experience in and commitment to clinical research;(2) the only State-supported level III NICU in New Mexico (50 beds, approx. 800 admissions and 175 very low birth weight admissions/year, expanding to a new facility in 2007), with a significant, under-represented Hispanic(48 percent) and Native American(12 percent) population;(3) one of the largest rural perinatal outreach programs in the nation, resulting in the vast majority of premature infants being inborn (87 percent);(4) the UNM General Clinical Research Center Pediatric Scatterbed Program (directed by Dr. Papile), established more than 25 years ago, which currently has 6 research nurses enrolling patients in 25 research protocols;(5) a comprehensive Developmental Care follow-up program comprised of 9 professionals with specific areas of expertise. This program, founded in 1978, begins with an assessment of each patient admitted to the NICU, designing individualized follow-up based on risk. The followup program works closely with the Neonatal Scatterbed Program of the GCRC to achieve follow-up rates consistently above 85 percent for research studies, and 100 percent for Dr. Watterberg's recent trial. Thus, the facilities, programs and patient population at UNM, together with the expertise and experience of the investigators in this application will make UNM a worthy addition to the NICHD Neonatal Research Network.
Showing the most recent 10 out of 87 publications
