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

夏普新生儿研究所临床中心 (Sharp NRI-CC)

基本信息

批准号：
10683030
负责人：
Anup C Katheria
金额：
$ 33.95万
依托单位：
SHARP MEMORIAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-01 至 2030-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10683030
关键词：
Address Admission activity Age Algorithms Beds Betula Genus Binding Sites Birth COVID-19 pandemic California Certification Clinic Clinical Clinical Research Clinical Trials Clinical Trials Design Closure by clamp Collaborations Community Hospitals Conduct Clinical Trials Consent County Coupled Doctor of Philosophy Enrollment Environment Evaluation Failure Family Future Gestational Age Goals Health Health Insurance Portability and Accountability Act Healthcare Systems Hispanic Home visitation Hospitalization Hospitals Hour Human Resources Infant Inpatients Joints Leadership Low Birth Weight Infant Medicine Milk Mission Multi-Institutional Clinical Trial Multicenter Neonatal Research Network Multicenter Trials Multiple Pregnancy National Institute of Child Health and Human Development Necrotizing Enterocolitis Neonatal Neonatology Newborn Infant Nurse Practitioners Observational Study Operative Surgical Procedures Outcome Participant Patient Care Patients Pediatric Nursing Population Premature Infant Process Productivity Provider Publishing Randomized Controlled Clinical Trials Randomized, Controlled Trials Recording of previous events Research Research Institute Research Personnel Research Project Summaries Research Support Services Site Specialist Standardization Text Messaging Therapeutic Training Transfusion Umbilical cord structure Woman Work antenatal clinical care clinical center cohort community center design eligible participant experience extreme prematurity follow-up high risk high risk infant improved natural hypothermia neonatal encephalopathy neonate pandemic disease participant enrollment patient population premature process improvement programs randomized trial recruit response support network treatment planning trial design trial enrollment

项目摘要

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.

长期以来，在极早产的婴儿中的项目摘要研究一直受到不足的限制入学和未完成试验。为了响应RFA-HD-23-002，此应用程序将证明尖锐的新生儿研究所（NRI）可以在 Eunice Kennedy Shriver Nichd新生儿研究网络（NRN）2023-2029周期。作为一个社区患者量较高，临床试验专业知识和出色的参与者入学率，三个主要的医院，三个主要优势强调了Sharp在NRN中的应用：1）两家夏普医院合计超过10,000 圣地亚哥县的婴儿每年有1,500多名NICU入院； 2）经验丰富的团体临床试验人员和神经发育专家已成功参加了多个临床试验，包括2001 - 2005年周期期间的NRN经验； 3）夏普的新生儿研究融合进入临床护理，允许通过训练有素的人参加所有高风险的人24/7招募许多临床试验的同意率超过80％，交付并完成了天前同意过程。特定目标1：将潜水员高风险新生儿招募到当前和未来的NRN试验中。锋利调查团队设计并简单地领导了几个大型多中心随机对照试验（RCT）。 Sharp NRI为西班牙裔大约40％的独特人口提供服务多个怀孕。特定目标2：参加NRN试验设计并有效地完成试验。提议的锋利 NRI-CC Pi，Anup Katheria，医学博士，具有效率，领导力和专业知识的良好记录。他设计了并领导了几个大型多中心RCT，并经常进行多次试验，包括早产婴儿接受挤奶或延迟的绳索夹试验（Premod2，20 Centers，n = 1,200，Est。完成9/2022）并完成了无毒婴儿试验中脐带挤奶的入学率（Minvi，10个中心，n = 1,730）。这两项试验均招募了近3,000名参与者进行二级研究。尽管 premod2暂时停止，这些试验在大流行期间继续入学。入学率是分别在6年和3年内完成（进行了2年的随访）。他经验丰富的调查团队包括领导NRN支持试验及其神经发育随访的两名高级调查员组成部分，再加上具有多种新生儿历史的富有成效的研究团队临床研究将为NRN提供更多的专业知识。特定目标3：在所有研究试验中优先考虑长期神经发育随访。尖锐的高风险婴儿随访计划提供纵向，全面的神经发育评估新生儿以夏普分娩并参加了临床试验，这有助于增加新生儿随访最近的临床研究试验的比率高于85％。