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）：德克萨斯大学休斯顿分校自 2001 年以来一直是新生儿和母婴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公正和普遍的答案。新生儿研究网络 (NRN) 的续展申请建议 1) 为严格设计和执行的临床试验做出贡献，2) 设计和领导新生儿重症监护病房重要管理问题的重大试验(NICU) 3) 推进涉及高危婴儿的临床研究方法： 1) 拥有大量具有种族和民族多样性的 NICU 人口（2014 年出生 8653 名新生儿，入院 1837 名 NICU）（44% 为黑人，46% 为黑人）。通用数据库中 % 白人、31% 西班牙裔、6% 亚裔）来自两个大型 NICU，即赫尔曼儿童纪念医院 (CMHH) 和西南纪念医院 (MSW)单一医院系统，2) NRN 研究的高注册率（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 和候补 PI {Kennedy 和 Tyson 博士曾担任 PI 和过去 24 年，他们分别在达拉斯德克萨斯大学西南分校和德克萨斯大学休斯顿分校担任候补 PI，共同领导德克萨斯大学休斯顿分校的临床研究和循证医学中心。他们致力于严格的研究方法并帮助其他研究人员进行研究设计，他们在众多已完成和正在进行的 NRN 随机试验的设计、执行和分析中发挥了重要作用 [例如维生素 A、4 项低温试验、光疗法]。 ，剖腹探查术与引流术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 NRN 估计器来评估预后22-25 周婴儿和 24-27 周婴儿早产儿视网膜病变 (ROP) 筛查标准的验证]}，4) 才华横溢的多学科合作者 [Kevin Lally（小儿外科主席兼 NEC 剖腹手术与引流术领导者）试验）、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，肯尼迪博士是一项钠补充剂和利尿剂析因试验的主要负责人，该试验已获得 NRN 指导委员会的批准，可以在下一个周期实施。 Green 博士和 Tyson 制定了一项批准的方案，在后续研究中纳入一个术语参考小组（以确定 Bayley III 评估的适当截止值），如果优先获得 NRN 资助，也可以实施该方案，以证明我们的承诺和专业知识。 ， 我们包括几项新的实用试验提案的摘要，供下一个资助周期考虑。 总之，该申请的优势包括 1) 新生儿重症监护病房 (NICU) 人群数量庞大，2) 在 NRN 研究参与和当地机构支持方面拥有良好的记录， 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。