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: 10348094
• 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/10348094
• 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; Pediatric Surgical Procedures; Performance; Phototherapy; Play; Population; Population Heterogeneity; Premature Infant; Prognosis; 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; participant enrollment; 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（由申请人提供）：UT休斯顿自2001年以来一直是新生儿和孕产妇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倚和可推广的答案。新生儿研究网络（NRN）的更新申请旨在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室（NICU）重要管理问题的重大试验3）推进涉及高危婴儿的临床研究方法。UT Houston网站有助于：（1）新生儿重症监护室（NICU）人口众多（2014年8653例出生和1837例新生儿重症监护室入院），种族和民族多样性（通用数据库中44%黑人，46%白色，31%西班牙裔，6%亚洲人）来自两个大型NICU，儿童纪念赫尔曼医院（CMHH）和纪念西南医院（MSW），2）NRN研究的高入学率（在最近完成的两项大型NRN试验中，在18个中心中排名第2和第5，3）熟练且忠诚的PI和替代PI {Kennedy博士和Tyson博士在过去的24年里一直担任PI和替代PI在德克萨斯大学西南分校（位于达拉斯），然后在德克萨斯大学休斯顿分校。他们一起指导UT休斯顿的临床研究和循证医学中心。他们在NRN中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。他们在许多已完成和正在进行的NRN随机试验[例如维生素A、4次低温试验、光疗、剖腹术与坏死性小肠结肠炎引流术（NEC）]的设计、性能和分析以及试验中无法解决的问题的严格队列研究[例如广泛使用的NRN估计器评估22-25周的预后]中发挥了重要作用。婴儿和验证早产儿视网膜病变（ROP）的筛选标准在24-27周。婴儿]}，4）才华横溢的多学科合作者[Kevin Lally（儿科外科主席和NEC试验剖腹术与引流术的负责人），Claudia Pedroza（参与多项NRN研究贝叶斯分析的统计学家），Charles绿色（心理学家和统计学家）]}，5）作为主席和院长，临床研究者的大力支持。Kennedy博士是一项钠补充剂和利尿剂析因试验的主要研究者，该试验已获得NRN指导委员会的批准，可在下一周期实施。绿色和泰森博士有一个批准的方案，在后续研究中包括一个术语参考组（以确定贝利III评估的适当截止值），如果优先考虑NRN资助，也可以实施。为了证明我们的承诺和专业知识，我们包括几个新的务实试验建议的摘要，供下一个供资周期考虑。总之，本申请的优势包括：1）大量多样化的NICU人群，2）NRN研究参与和当地机构支持的良好记录，3）多名经验丰富的研究者积极参与NRN研究的设计、审查和解释。