NICHD Cooperative Multicenter Neonatal Research Network

点击翻译按钮获取中文摘要

 DESCRIPTION (provided by applicant): Academic faculty in the UCLA Neonatology Division are strongly devoted to remaining in all clinical research activities under the auspices of the NRN multi-center trials. UCLA's "virtual research center" and "team science" is unique in undertaking our collective clinical trial; integrating HRIF satellite clinics at five NICUs; a collective dedication to clinical research, ability to translate discoveries into clinical trials, nd interaction with clinical and basic science investigators on campus. Additional strengths include the following: selected site PIs and alternate PI have track records in conducting and participating in multi- center trials within a group of highly collaborative divisional faculty, IR approved comprehensive Neonatal and Perinatal Databases, HRIF clinic programs with >95 % retention rates and long term follow-up to 8 years of age with Developmental Pediatric faculty and an established culture of clinical trial participation in UCLA affiliated NICUs. Our first and vital step in patient recruitment is maintaining around the clock close communication daily between the NRN site PIs, research coordinators, and handoffs to varying NICU team members (i.e. neonatologist, charge and staff nurses, fellows, and NNPs) who identify eligible patients and implement study protocols to strengthen recruitment and retention and minimize protocol violations. We hold regular NCRC clinical trials/data analysis sessions. Therefore we propose the following aims: 1] To develop scientifically sound protocols within the NRN for ancillary studies that will be rigorously tested and implemented at most participating centers to be able to identify the clinical relevance of the intervention to neonatal outcomes. 2] To successfully compete to retain membership with the NICHD under a cooperative agreement in an ongoing program designed to perform interventional and observational longitudinal studies in infants. 3] To share data in a timely manner with the Data Coordinating Center and Data and Safety Monitoring Committee and contribute towards the final reporting of results along with development and data analysis of all ancillary projects that may emerge from the NRN. 4] To provide valuable contributions for future ideas and discussions in the NRN steering committee that will develop into well designed hypotheses driven clinical trials that can be implemented across NRN sites.