Sharing Developmental, Meta, and Video Data from Preterm Infants Enrolled in the SPEEDI Clinical Trial

共享参加 SPEEDI 临床试验的早产儿的发育、元数据和视频数据

• 批准号: 10789838
• 负责人: Stacey Chapman Dusing
• 金额: $ 17.55万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2025-09-15
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10789838
• 关键词: 2 year old; Address; Adherence; Age; Archives; Books; Cerebral Palsy; Child; Child Development; Child Health; Child Rearing; Childhood; Clinical; Clinical Trials; Code; Cohort Studies; Common Data Element; Data; Data Set; Detection; Development; Developmental Delay Disorders; Diagnosis; Enrollment; Evaluation; Family; Funding; Funding Opportunities; Future; Goals; Guidelines; Hospitals; Human Development; Incidence; Individual; Infant; International; Intervention; Intervention Studies; Language Development; Life; Measures; Modeling; Motor; Movement; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Neurologic; Outcome; Outcome Measure; Parent-Child Relations; Parents; Physical Medicine; Play; Pregnancy; Premature Infant; Privatization; Problem Solving; Prospective cohort; Publications; Publishing; Recommendation; Recording of previous events; Rehabilitation therapy; Research; Research Personnel; Risk; Sensory; Severities; Time; Training Programs; United States National Institutes of Health; Validation; Visit; arm; benefit sharing; clinical trial analysis; cohort; comparative effectiveness study; data sharing; design; extreme prematurity; high risk; improved; infant outcome; innovation; insight; interest; member; parent project; personalized medicine; predictive modeling; prognostic value; repository; response; secondary analysis; therapy development; time use; tool

Rigorously collected longitudinal developmental data from very preterm infants will propel the fields of child development and childhood rehabilitation forward in 3 ways: 1) Combining data sets to increase rigor of predictive models and determine individual and cumulative risk for developmental delay or Cerebral Palsy (CP), 2) Analysis of clinical trial outcomes using consistent outcome measures could replace the need for some comparative effectiveness studies, 3) Intervention data from multiple studies will provide data for preliminary modeling of personalized medicine rehabilitation interventions. However, to achieve any of these goals, sharing of longitudinal developmental data from cohort studies and clinical trials is crucial.1,2 The purpose of this proposal for Funding Opportunity Announcement (FOA) Number PAR-22-261 Archiving and Documenting Child Health and Human Development Data Sets is to ensure that data from this three arm multi-site clinical trial of 85 very preterm infants, funded by NICHD prior to NIH’s guidelines for data sharing, is made available to research teams who could use it to address research questions beyond the initial study aims.3 Now is the time to fund the transition of this exciting data from a private dataset into a shared data set allowing the wealth of secondary analysis or harmonization with data set from other clinical trials which likely already include sharing plans. For example NICU trials including sensory intervention4, parenting5, and combined6 trials could be compared with the parent project. In addition, research teams focusing on understanding development are excited to use this data set and videos to answer questions on topics ranging from language acquisition to fine motor development. Infants born preterm are at high risk of developmental delays with up to 20 percent of infants born very preterm diagnosed with cerebral palsy (CP) at 2 years of age. While the development of the Common Data Elements for CP (CDE_CP)7 have increased the rigor of individual studies, the use of these highly recommended outcomes also increases the likelihood of combining data sets. The parent project (R01 HD093624, NCT03518736) uses a combination of outcome measures from the CDE_CP which will enable harmonization with other data sets. In addition, the use of innovative outcomes that can be used to evaluate early problem-solving in infants and parent infant relationships starting in the NICU will allow for new and innovative developmental questions. Thus, researchers from a broad number of fields will benefit from sharing this data. The aims included in this proposal focus on what can be done with this data set alone. Aim 1) Provide an accessible dataset with longitudinal data on developmental measures including the recommended common data elements for CP (CDE_CP) and additional measures that are sensitive to change in children without CP. Since the 2017 publication of the International Guidelines for the Early and Accurate Detection of CP8, hospitals with NICUs around the world have been implementing the use of the General Movement Assessment (GMA) into research and practice. Public access to GMA videos from the NICU and at 10-14 weeks post term age combined with outcome data could drastically increase the ability to conduct research on the prognostic value of the GMA and the General Movement Observation Scale (GMOS) which many be more sensitive to change over time and can be scored from available GMA videos. The parent project includes GMA data at enrollment between 34-42 weeks of gestation, plus 1-2 videos at the most predictive age (10-14 weeks post term) and developmental outcomes at 12 and/or 24 months. Aim 2) Provide a shared data set with longitudinal assessment using the Hammersmith Infant Neurological Exam (HINE) that can be used to determine if the HINE is sensitive to change over time. Innovative longitudinal intervention studies, such as the parent project, are beginning to evaluate interventions initiated in the first weeks of life with the goal of reducing the incidence and severity of developmental delays and cerebral palsy. The parent project uses the HINE as one component of determining if the child has CP. However, this prospective cohort is large enough to evaluate sensitivity to change over time using the HINE which has not been previously evaluated. Thus, is it crucial that data from research with young infants with or at high risk of having CP are publicly accessible to allow for secondary analysis such as tool validation. Aim 3) Publish high quality fidelity data which could be compared with other interventions started in the NICU or at 14 weeks of age. Rehabilitation interventions have a long history of NOT monitoring fidelity. This data set includes videos of 20% of the intervention visits which have been scored to measure adherence to the principles of the intervention. Other teams will be able to use the guidance included in the code book along with videos to improve their own fidelity evaluation or initiate comparative effectiveness study. Impact: PI Dusing is currently participating in the NICHD funded training program Reproresearch and is a member of the Databrary Launch Team, magnifying her previous interest in making this incredible data set available for public use. While epidemiolocal data can provide some insight into the needs or predictors of infant outcomes, primary longitudinally collected data is likely to be more clinically meaningful and more accurate. This data will contribute to a greater understanding of development and rehab for children.

严格收集的非常早产的纵向发育数据将推动儿童的领域 开发和儿童康复以三种方式前进：1）结合数据集以增加严格的严格性 预测模型并确定发育延迟或脑瘫的个体和累积风险 （CP），2）使用一致的结果指标对临床试验结果进行分析可以取代对 一些比较有效性研究，3）来自多项研究的干预数据将为 个性化医学康复干预措施的初步建模。但是，要实现其中任何一个 目标，共享队列研究和临床试验的纵向发展数据至关重要。1,2 此提案的资金机会公告（FOA）编号的目的 PAR-22-261存档和记录儿童健康和人类发展数据集是为了确保 来自这三个ARM的85名非常早产的三个ARM多站点临床试验的数据，由NICHD资助。 数据共享指南可用于可以使用它来解决研究的研究团队 超出初步研究的问题。3现在是时候为这些令人兴奋的数据提供资金 私人数据集进入共享数据集，允许辅助分析或与数据集进行协调 来自其他可能已经包括共享计划的临床试验。例如NICU试验包括感官 Intervention4，Parenting5和合并6个试验可以与家长项目进行比较。此外，研究 专注于理解发展的团队很高兴使用此数据集和视频回答问题 关于从语言获取到精细运动发展的主题。 出生的早产婴儿的发育延迟风险很高，最多20％的婴儿出生 在2岁时诊断为脑瘫（CP）的早产。而共同数据的发展 CP（CDE_CP）7的元素增加了个体研究的严格性，这些使用高度使用 推荐的结果还增加了组合数据集的可能性。父项目（R01） HD093624，NCT03518736）使用CDE_CP的结果指标的组合 与其他数据集协调。此外，使用可用于评估的创新结果 从NICU开始的婴儿和父母关系的早期解决问题将允许新的和 创新的发展问题。这就是来自广泛领域的研究人员将受益于共享 这个数据。本提案中包含的目的侧重于仅使用此数据集可以做什么。 目标1）提供一个可访问的数据集，其中包含有关发展测量值的纵向数据 推荐的CP（CDE_CP）的常见数据元素以及对 没有CP的儿童变化。自2017年发布《国际早期和国际准则》以来 准确检测CP8，世界各地的NICUS医院一直在实施使用 一般运动评估（GMA）进入研究和实践。公众访问GMA视频 NICU和学期后10-14周与结果数据相结合，可能会大大提高 对GMA的预后价值和一般运动观察量表（GMO）进行研究 随着时间的流逝，许多人更敏感，并且可以从可用的GMA视频中得分。父母 项目包括34-42周妊娠之间的GMA数据，以及最多的1-2个视频 预测年龄（任期后10-14周）和12个月和/或24个月的发展结果。 AIM 2）使用Hammersmith婴儿提供纵向评估的共享数据集 可用于确定Hine是否敏感随时间变化的神经检查（HINE）。 创新的纵向干预研究，例如父母项目，开始评估干预措施 在生命的头几周开始，目的是减少发育延迟的事件和严重性 和脑瘫。父项目将HINE用作确定孩子是否具有CP的组成部分。 但是，该前瞻性队列足够大，可以评估使用Hine随时间变化的灵敏度 以前尚未评估。这是至关重要的是，与年轻婴儿的研究数据至关重要 可以公开访问CP的高风险，以进行辅助分析，例如工具验证。 AIM 3）发布高质量的保真度数据，可以将其与其他干预措施进行比较 NICU或14周龄。康复干预措施的历史悠久，没有监测保真度。 该数据集包括20％的干预访问的视频，这些视频已进行了测量以衡量依从性 干预原则。其他团队将能够使用代码簿中包含的指导 与视频一起改善自己的保真度评估或启动比较有效性研究。 影响：Pi Dusing目前正在参加NICHD资助的培训计划RERORESEARCH，这是一个 Databrary发射团队的成员，放大了她以前对制作此令人难以置信的数据集的兴趣 可用于公共用途。虽然流行生素数据可以提供一些对需求或预测指标的见解 婴儿结果，主要的纵向收集数据可能更有意义，更有意义 准确的。这些数据将有助于对儿童的发展和康复有更多的了解。