Multicenter Network of Neonatal Intensive Care Units-University of Texas at Houston (UT Houston) Clinical Center

新生儿重症监护病房多中心网络-德克萨斯大学休斯顿分校（UT Houston）临床中心

• 批准号: 9898400
• 负责人: JON E. TYSON
• 金额: $ 29.08万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9898400
• 关键词: Address; Admission activity; Area; Asians; Bayesian Analysis; Bayesian Method; Benefits and Risks; Biometry; Birth; Budgets; Censuses; Chairperson; Child; Childhood; Clinical; Clinical Investigator; Clinical Management; Clinical Research; Clinical Trials; Cohort Studies; Collaborations; Complex; Consult; Databases; Degree program; Development; Discipline; Discipline of Nursing; Diuretics; Drainage procedure; Effectiveness; Enrollment; Epidemiology; Ethics; Evidence Based Medicine; Faculty; Follow-Up Studies; Funding; Goals; Health Services Research; Hispanics; Hospitals; Hydrocortisone; Individual; Infant; Intervention; Investigation; Laparotomy; Lead; Link; Long-Term Effects; Master' s Degree; Maternal-fetal medicine; Medical center; Methods; Morbidity - disease rate; Multicenter Neonatal Research Network; Multicenter Studies; Necrotizing Enterocolitis; Neonatal; Neonatal Intensive Care Units; Neonatology; Outcome; Patients; Pediatric Surgical Procedures; Performance; Phototherapy; Play; Population; Population Heterogeneity; Premature Infant; Protocol Compliance; Protocols documentation; Psychologist; Psychology; Public Health; Randomized; Research; Research Design; Research Ethics; Research Infrastructure; Research Methodology; Research Personnel; Retinopathy of Prematurity; Role; Safety; Sample Size; Schools; Site; Sodium; Supplementation; Survivors; System; Talents; Teaching Hospitals; Texas; Thiazide Diuretics; Training; Universities; Validation; Vitamin A; biomedical informatics; clinical center; cohort; design; ethnic diversity; experience; follow-up; health care economics; high risk infant; improved outcome; medical schools; member; multidisciplinary; natural hypothermia; outcome forecast; pragmatic trial; preference; programs; public health relevance; racial and ethnic; racial diversity; randomized trial; screening

 DESCRIPTION (provided by applicant): UT Houston has been a member of both the Neonatal and Maternal Fetal Medicine Research Networks since 2001. Large multicenter networks are needed to conduct large rigorous randomized trials that provide unbiased and generalizable answers to important clinical management questions. This renewal application for the Neonatal Research Network (NRN) proposes to 1) contribute to rigorously designed and executed clinical trials, 2) design and lead major trials of important management questions in the neonatal intensive care unit (NICU) 3) advance the methods in clinical research involving high-risk infants. The UT Houston site contributes: 1) a large NICU population (8653 births and 1837 NICU admissions in 2014) with racial and ethnic diversity (44% Black, 46% White, 31% Hispanic, 6% Asian in Generic Database) from two large NICUs, Children's Memorial Hermann Hospital (CMHH) and Memorial Southwest (MSW) within a single hospital system, 2) high enrollment in NRN studies (ranked 2nd and 5th of 18 centers in the two most recently completed large NRN trials, 3) skilled and committed PI and Alternate PI {Drs. Kennedy and Tyson have served as PI and Alternate PI for the past 24 years at UT Southwestern in Dallas and then at UT Houston. Together, they direct the Center for Clinical Research and Evidence-Based Medicine at UT Houston. They are known in the NRN for their commitment to rigorous research methods and for helping other investigators with study design. They have played major roles in the design, performance, and analysis of numerous completed and ongoing NRN randomized trials [e.g. Vitamin A, 4 Hypothermia trials, Phototherapy, Laparotomy vs Drainage for Necrotizing Enterocolitis (NEC)] and rigorous cohort studies of issues not addressable in trials [e.g. the widely used NRN estimator to assess prognosis of 22-25 wk. infants and the validation of screening criteria for retinopathy of prematurity (ROP) in 24-27 wk. infants]}, 4) talented multidisciplinary collaborators [Kevin Lally (Chair of Pediatric Surgery and leader in Laparotomy vs Drainage for NEC trial), Claudia Pedroza (a statistician involved in Bayesian analyses of multiple NRN studies), Charles Green (psychologist and statistician)]}, 5) strong support from clinical investigators as Chairman and Dean. Dr. Kennedy is the PI of a factorial trial of sodium supplementation and diuretics that has been approved by the NRN Steering Committee and could be implemented in the next cycle. Drs. Green and Tyson have an approved protocol to include a term reference group in the follow-up study (to determine appropriate cut-offs for Bayley III assessments) that could also be implemented if prioritized for NRN funding. To demonstrate our commitment and expertise, we include abstracts of several new proposals of pragmatic trials for consideration in the next funding cycle. In summary, the strengths of the this application include 1) a large diverse NICU population, 2) a strong track record in NRN study participation and local institutional support, and 3) multiple highly experienced investigators actively involved in the design, review, and interpretation of NRN studies.

 描述(由申请者提供)：德克萨斯大学休斯顿分校自2001年以来一直是新生儿和母亲胎儿医学研究网络的成员。需要大型多中心网络来进行大型严格的随机试验，为重要的临床管理问题提供无偏见和可推广的答案。新生儿研究网络(NRN)的续签申请建议1)促进严格设计和执行的临床试验，2)设计和领导新生儿重症监护病房(NICU)重要管理问题的主要试验3)推动涉及高危婴儿的临床研究方法。德克萨斯大学休斯顿分校的网站贡献了：1)来自两个大型NICU-儿童纪念赫尔曼医院(CMHH)和西南纪念医院(MSW)的大量NICU人口(2014年出生8653人，NICU入院人数1837人)，种族和民族多样性(44%黑人，46%白人，31%西班牙裔，6%亚洲人)，2)NRN研究的高入学率(在最近完成的两个大型NRN试验的18个中心中排名第二和第五，3)技术娴熟、尽职尽责的私家侦探和替补私家侦探(肯尼迪博士和泰森博士在过去24年中先后在达拉斯的德克萨斯大学西南分校和休斯顿大学担任私家侦探和候补私家侦探。他们共同领导着德克萨斯大学休斯顿大学的临床研究和循证医学中心。他们在NRN以致力于严格的研究方法和帮助其他研究人员进行研究设计而闻名。他们在众多已完成和正在进行的NRN随机试验[例如，维生素A、4项低温试验、光疗、剖腹与引流治疗坏死性小肠结肠炎(NEC)]以及对试验中无法解决的问题的严格队列研究[例如，广泛使用的评估22-25周预后的NRN估计器]的设计、执行和分析中发挥了重要作用。早产儿视网膜病变筛查标准在24-27周内的有效性。婴儿]}，4)才华横溢的多学科合作者[Kevin Lally(NEC试验的开腹和引流方面的主席和领导者)，Claudia Pedroza(参与多项NRN研究的贝叶斯分析的统计学家)，Charles Green(心理学家和统计学家)}，5)作为主席和院长的临床研究人员的大力支持。肯尼迪博士是一项钠补充剂和利尿剂因子试验的PI，该试验已经得到NRN指导委员会的批准，可能会在下一个周期实施。格林博士和泰森博士已经批准了一项协议，在后续研究中包括一个术语参考小组(以确定贝利III评估的适当分界点)，如果NRN资助的优先顺序也可以实施。为了显示我们的承诺和专业知识，我们提供了几个新的务实试验提案的摘要，供下一个供资周期审议。总之，这项申请的优势包括1)大量多样化的NICU人群，2)在NRN研究参与和当地机构支持方面的良好记录，以及3)多名经验丰富的研究人员积极参与NRN研究的设计、审查和解释。