Archiving and Documenting Data from the NICHD Neonatal Research Network

归档和记录来自 NICHD 新生儿研究网络的数据

• 批准号: 9803847
• 负责人: Abhik Das
• 金额: $ 8.94万
• 依托单位: RESEARCH TRIANGLE INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-09 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9803847
• 关键词: Access to Information; Adverse event; Affect; Archives; Benchmarking; Birth; Birth Weight; Bronchopulmonary Dysplasia; Caring; Cessation of life; Child Health; Clinical; Clinical Trials; Communities; Continuous Positive Airway Pressure; Data; Data Coordinating Center; Data Element; Data Set; Documentation; Ensure; Funding; Future; Gestational Age; Goals; Hour; Human Development; Infant; Infrastructure; Institutional Review Boards; International; Intervention; Investigation; Knowledge; Low Birth Weight Infant; Lung diseases; Measurable; Medicine; Meta-Analysis; Monitor; Morbidity - disease rate; Multicenter Neonatal Research Network; National Institute of Child Health and Human Development; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Outcome; Oxygen; Participant; Physiologic pulse; Pregnancy; Premature Infant; Preventive therapy; Principal Investigator; Publishing; Pulse Oximetry; Reporting; Research; Research Design; Research Personnel; Resources; Respiratory Failure; Safety; Specimen; Subgroup; Survival Rate; Testing; Training; Treatment Efficacy; Treatment Protocols; United States National Institutes of Health; clinical research site; data warehouse; evidence base; experience; improved; inhaled nitric oxide; neonatal care; neonate; premature; pressure; prevent; randomized trial; repository; respiratory; response; surfactant; treatment strategy; trial comparing

Project Summary The Neonatal Research Network (NRN) was established by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in 1993 to facilitate the advancement of neonatal care by establishing a network of academic centers that, by rigorous investigation of the safety and efficacy of treatment strategies for newborn infants, can meaningfully enhance the evidence base for neonatal medicine. The Inhaled Nitric Oxide for Preterm Infants With Severe Respiratory Failure (Preemie iNO) Trial, the Benchmarking Initiative to Reduce Bronchopulmonary Dysplasia (Benchmarking Trial), and the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) are three studies involving respiratory management strategies and outcomes for extremely premature/low birthweight neonates conducted by the NRN before the NICHD Data and Specimen Hub (N-DASH) became available (2000-2009). The Preemie iNO trial tested whether inhaled nitric oxide reduces death or bronchopulmonary dysplasia (BPD) in low birth weight (401-1500 g) infants less than 34 weeks gestational age with severe lung disease. The Benchmarking trial tested whether Neonatal Intensive Care Unit teams trained in benchmarking—comparing care practices between different NICUs to see which practices prevent BPD—and quality improvement would change practices and improve rates of survival without BPD in inborn neonates with birth weights <1250 g. SUPPORT compared continuous positive airway pressure initiated at birth with early administration of surfactant for infants born at 24 to 27 weeks gestation to determine the effect on BPD and survival of premature infants. The results of all these studies have been published, but comprehensive datasets and documentation are not available in any publicly accessible data repository. Meanwhile, these data remain highly valuable to researchers, particularly given that despite measurable improvements in neonatal care over the past 30 years, BPD rates have not improved for extremely premature babies and few efficacious preventive therapies exist. However, because these studies were completed prior to the existence of N-DASH, they are not available in a public repository that would make them proactively available to researchers to spark new investigations. Therefore, RTI International proposes to use our institutional knowledge of the NRN and our DCC infrastructure to achieve the following specific aims in response to PAR-16-149 Archiving and Documenting Child Health and Human Development Data Sets (R03): (1) create public use datasets and documentation for the Preemie iNO, Benchmarking, and SUPPORT trials; (2) harmonize the data to facilitate analyses that make use of data from multiple studies; and (3) share the public use datasets and documentation through N-DASH.

项目摘要 新生儿研究网络（NRN）是由尤尼斯肯尼迪施莱佛国家研究所建立的 1993年，儿童健康与人类发展委员会（NICHD）成立，通过以下措施促进新生儿护理的发展 建立一个学术中心网络，通过严格调查的安全性和有效性， 新生儿的治疗策略，可以有意义地加强新生儿医学的证据基础。 吸入一氧化氮治疗严重呼吸衰竭早产儿（早产儿iNO）试验， 减少支气管肺发育不良的基准计划（基准试验）和表面活性剂 气道正压通气和脉搏血氧测定试验（SUPPORT）是三项涉及呼吸系统的研究， 极早产/低出生体重新生儿的管理策略和结果 NRN在NICHD数据和标本中心（N-DASH）可用之前（2000-2009年）。早产儿iNO 一项试验测试了吸入一氧化氮是否会降低低出生体重儿的死亡或支气管肺发育不良（BPD） （401-1500 g）胎龄小于34周的患有严重肺部疾病的婴儿。基准测试 测试新生儿重症监护室团队是否接受过基准比较护理实践的培训 在不同的NICU之间，看看哪些实践可以防止BPD-质量改进会发生变化 提高出生体重<1250 g的新生儿无BPD的存活率。支持 比较出生时开始的持续气道正压通气与婴儿早期给予表面活性物质 在妊娠24至27周出生，以确定对BPD和早产儿存活率的影响。结果 所有这些研究都已发表，但全面的数据集和文件在 任何可公开访问的数据存储库。与此同时，这些数据对研究人员来说仍然非常有价值， 特别是考虑到尽管在过去30年中新生儿护理有了可衡量的改善， 对于极早产儿没有改善，并且几乎没有有效的预防性治疗。然而，在这方面， 由于这些研究是在N-DASH存在之前完成的，因此无法公开获得 这将使他们主动提供给研究人员，以激发新的调查。因此，我们认为， RTI国际建议利用我们对NRN和DCC基础设施的机构知识， 实现以下具体目标，以响应PAR-16-149《儿童健康和记录》， 人类发育数据集（R 03）：（1）为早产儿iNO创建公共使用数据集和文档， 基准测试和支持试验;（2）协调数据，以促进利用来自 多项研究;（3）通过N-DASH共享公共使用数据集和文档。