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.

项目摘要对极早产儿的研究长期以来一直受到不充分的限制注册和未能完成试验作为对 RFA-HD-23-002 的回应，本申请将证明：夏普新生儿研究所 (NRI) 作为临床中心 (夏普 NRI-CC) 可以在以下领域做出重大贡献： Eunice Kennedy Shriver NICHD 新生儿研究网络 (NRN) 2023-2029 年周期作为一个社区。医院拥有大量患者、临床试验专业知识和出色的参与者入组率，三个主要夏普在 NRN 中的应用凸显了其优势： 1) 两家夏普医院合计交付了超过 10,000 名患者圣地亚哥县每年有超过 1,500 名 NICU 入院婴儿 2) 经验丰富的团队；临床试验专家和神经发育专家已成功参与多项临床试验，包括之前 NRN 在 2001-2005 年周期的经验；3) Sharp 整合新生儿研究进入临床护理，允许通过训练有素的人员 24/7 招募参加所有高风险的人员分娩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。研究团队设计并同时领导了多项大型多中心随机试验 (RCT) 夏普 NRI 服务于大约 40% 的西班牙裔人口，并且拥有大量的服务。多胎妊娠。具体目标2：参与NRN试验设计并帮助高效完成夏普提出的试验。 NRI-CC PI，Anup Katheria，医学博士，在效率、领导力和专业知识方面拥有良好的记录。并领导了多项大型多中心随机对照试验，并常规同时进行多项试验，包括接受挤奶或延迟脐带结扎试验的早产儿（PREMOD2，20 个中心，N=1,200，估计值）完成 9/2022）并完成非活力婴儿脐带挤奶试验的登记（MINVI，10 个中心，N=1,730）。尽管如此，两项试验仍招募了近 3,000 名参与者。 PREMOD2 暂时停止，这些试验在大流行期间继续入组；分别用了 6 年和 3 年的时间完成（并持续进行 2 年的后续行动）。包括领导 NRN SUPPORT 试验及其神经发育随访的两名高级研究人员组成部分，再加上一支富有成效的研究团队，该团队在进行多项新生儿临床研究将为 NRN 提供额外的专业知识。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。风险婴儿随访计划提供纵向、全面的神经发育评估在夏普分娩并参加临床试验的新生儿有助于增加新生儿的整体随访最近的临床研究试验的比率超过 85%。