Sharp Neonatal Research Institute Clinical Center (Sharp NRI-CC)

对极早产儿的项目总结研究长期以来一直受到不足的限制 注册和未完成试验。作为对RFA-HD-23-002的响应，此应用程序将演示 夏普新生儿研究所(NRI)作为临床中心(夏普NRI-CC)可以在 尤尼斯·肯尼迪·施莱弗新生儿研究网络(NRN)2023-2029周期。作为一个社区 拥有大量患者、临床试验专业知识和出色的参与者登记的医院，主要有三个方面 夏普的强项强调了夏普在NRN中的应用：1)两家夏普医院加起来提供超过10,000 圣地亚哥县的婴儿，每年有1500多名NICU入院；2)一群经验丰富的 临床试验专家和神经发育专家成功地参与了多项临床试验， 包括2001-2005年周期内以前的NRN经验；3)夏普对新生儿研究的整合 进入临床护理，允许通过参加所有高风险的训练有素的人员全天候招聘 并完成产前同意程序，许多临床试验的同意率超过80%。 具体目标1：将不同的高危新生儿纳入当前和未来的NRN试验。犀利的 研究团队设计并同时领导了几个大型多中心随机对照试验 (RCT)。夏普NRI服务于约40%的西班牙裔独特人口，并拥有大量 多胎怀孕。 具体目标2：参与NRN试验设计，帮助高效完成试验。建议的夏普 NRI-CC Pi，医学博士Anup Katheria，在效率、领导力和专业知识方面拥有公认的记录。他设计了 并领导了几个大型多中心随机对照试验，并定期同时进行多项试验，包括 接受挤奶或延迟夹脐带试验的早产儿(PREMOD2，20个中心，N=1,200，Est. 完成9/2022)，并完成了无活力婴儿脐带挤奶试验的登记 (MINVI，10中心，N=1,730)。这两项试验都招募了近3000名参与者进行二级研究。尽管 PREMOD2被暂时停止，这些试验在大流行期间继续招募；招募人数为 分别在6年和3年内完成(持续2年的后续行动)。他的经验丰富的调查团队 包括领导NRN支持试验及其神经发育后续行动的两名高级调查人员 组成部分，再加上一支富有成效的研究团队，有处理多名新生儿的丰富历史 临床研究将为NRN提供更多的专业知识。 具体目标3：在所有研究试验中优先考虑长期神经发育随访。夏普高中 风险婴儿跟踪计划为以下方面提供纵向、全面的神经发育评估 在夏普分娩的新生儿参加了有助于增加总体新生儿随访的临床试验 最近的临床研究试验的比率在85%以上。

PROJECT SUMMARY Research in extremely preterm infants has long been constrained by inadequate enrollment and failure to complete trials. In response to RFA-HD-23-002, this application will demonstrate that the Sharp Neonatal Research Institute (NRI) can substantially contribute as a clinical center (Sharp NRI-CC) in the Eunice Kennedy Shriver NICHD Neonatal Research Network (NRN) 2023-2029 cycle. As a community hospital with high patient volumes, clinical trial expertise, and exceptional participant enrollment, three main strengths underscore Sharp’s application into the NRN: 1) Two Sharp hospitals combined deliver over 10,000 babies in San Diego County, with over 1,500 NICU admissions annually; 2) A highly experienced group of clinical trialists and neurodevelopmental specialists have successfully participated in multiple clinical trials, including previous NRN experience during the 2001-2005 cycle; 3) Sharp’s integration of neonatal research into clinical care which allows for recruitment 24/7 through highly trained personnel who attend all high-risk deliveries and complete the antenatal consent process, with consent rates of over 80% for many clinical trials. Specific Aim 1: Enroll diverse high-risk neonates into current and future NRN trials. The Sharp investigative team has designed and simultaneously led several large multicenter randomized controlled trials (RCT). The Sharp NRI serves a unique population of approximately 40% Hispanic and has a high volume of multiple pregnancies. Specific Aim 2: Participate in NRN trial design and help complete trials efficiently. The proposed Sharp NRI-CC PI, Anup Katheria, MD, has a proven track record of efficiency, leadership, and expertise. He designed and led several large multicenter RCTs and routinely conducts multiple trials simultaneously, including Premature Infants Receiving Milking or Delayed Cord Clamping trial (PREMOD2, 20 centers, N=1,200, est. completion 9/2022) and completed enrollment in the Umbilical Cord Milking in Non-Vigorous Infants trial (MINVI, 10 centers, N=1,730). Both trials enrolled nearly 3,000 participants for secondary studies. Despite PREMOD2 being temporarily stopped, these trials continued enrolling during the pandemic; enrollment was completed in 6 and 3 years (with ongoing 2-year follow-up), respectively. His experienced investigative team including two senior investigators who led the NRN SUPPORT trial and its neurodevelopmental follow-up component, coupled with a productive research team with a strong history of conducting multiple neonatal clinical studies, will provide additional expertise to the NRN. Specific Aim 3: Prioritize long-term neurodevelopmental follow-up in all research trials. The Sharp High Risk Infant Follow-Up program provides longitudinal, comprehensive neurodevelopmental assessments for newborns delivered at Sharp and enrolled in clinical trials that helped increase the overall neonatal follow-up rates to above 85% for recent clinical research trials.