Academic faculty members of the division of Neonatology at UCLA have collectively made a commitment to conduct clinical research under the auspices of the NRN multi-center trials. We will recruit adequate number of patients to generate necessary power to test stated hypotheses, thereby allowing valid conclusions about primary outcome measures. To compete for membership in the ongoing multi-center NICHD-NRN that sets the nation-wide "gold standard" for clinical trials, we have 1] the necessary infrastructure in our UCLA "Virtual NICHD-NRN type site" called the Neonatal Clinical Research Center (NCRC), 2] selected site PI and alternate PI with track records in conducting and participating in multi-center trials from a group of highly collaborative divisional faculty, 3] IRB approved comprehensive Neonatal Database, 4] HRIF clinic Program with >90% retention rate, 5] capability of long term follow-up with Developmental Pediatric faculty up to 8 years of age, 6] culture in UCLA-NICUs among multi-disciplinary ancillary staff of participating in clinical trials, 7] First line of defense for patient recruitment consisting of Neonatology fellows, NNPs, Clinical Research Nurse Specialists, and Neonatology Faculty who will identify eligible patients and implement study protocols 24/7 days a week, and 8] Experienced clinical research nurse coordinator, 9] Regular NCRC clinical trials/data analysis sessions that led to development of a concept application, "Randomized Control Trial of Neuro-protection by Anti-Seizure Medications in HIE Neonates subjected to Hypothermia based on our existent research strengths in this field. This empowers us to propose the following specific aims:1] To participate with NRN under a cooperative agreement in an ongoing multi-center program designed to perform interventional and observational clinical studies in newborn babies, 2] To contribute to the steering committee of NRN ideas and discussions targeted at developing well designed clinical trials that can be implemented in NRN sites, and 3] To share data in a timely manner with the Centralized Data Coordinating Center and the DSMC, and contribute towards the final reporting of results along with development and data analyses of ancillary projects that may emerge from the NRN. UCLA's participation as a potential site will provide an exciting opportunity for us and we project that recruitment of patients with diverse ethnicity from the Los Angeles area will prove to be an important contribution to the NRN.
|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|