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.

严格收集早产儿的纵向发育数据将推动儿童领域的研究。 发展和儿童康复向前推进3种方式：1）结合数据集，以提高严谨性 预测模型，并确定发育迟缓或脑瘫的个体和累积风险 (CP)2）使用一致的结果指标分析临床试验结果可以取代 一些比较有效性研究，3）来自多项研究的干预数据将为以下方面提供数据： 个性化医疗康复干预的初步建模。然而，要实现这些目标， 因此，共享队列研究和临床试验的纵向发育数据至关重要。 本提案的目的是提供资金机会公告（FOA）编号 PAR-22-261收集和记录儿童健康和人类发展数据集的目的是确保 来自85名极早产儿的三组多中心临床试验的数据， 数据共享的指导方针，提供给研究团队谁可以使用它来解决研究 3现在是时候为这些令人兴奋的数据从一个 将私有数据集转换为共享数据集，允许进行大量的二次分析或与数据集协调 其他临床试验可能已经包括共享计划。例如NICU试验， 干预试验4、亲本试验5和组合试验6可与亲本项目进行比较。此外，研究 专注于了解开发的团队很高兴使用此数据集和视频来回答问题 从语言习得到精细运动发育。 早产儿有很高的发育迟缓风险，高达20%的早产儿 2岁时被诊断为脑瘫（CP）的早产儿。虽然共同数据的发展 CP（CDE_CP）7的元素增加了个体研究的严谨性，这些高度 建议的结果也增加了合并数据集的可能性。父项目（R 01 HD 093624，NCT 03518736）使用CDE_CP的结局指标组合， 与其他数据集协调一致。此外，使用可用于评估的创新成果， 在新生儿重症监护室开始的婴儿和父母婴儿关系的早期解决问题将允许新的， 创新发展问题。因此，来自广泛领域的研究人员将从共享中受益 这些数据。本提案中的目标侧重于仅利用这一数据集就能做些什么。 目标1）提供一个可获得的数据集，其中载有关于发展措施的纵向数据，包括 建议的CP通用数据元素（CDE_CP）和对以下方面敏感的其他措施 无CP儿童的变化。自2017年发布《国际早期和晚期癌症指南》以来， CP 8的精确检测，世界各地拥有NICU的医院都在实施使用 一般运动评估（GMA）的研究和实践。公众可从 新生儿重症监护室和10-14周的足月后年龄结合结果数据可以大大提高能力， 研究GMA和一般运动观察量表（GMOS）的预后价值 其可以对随时间的变化更敏感，并且可以从可用的GMA视频中评分。母 项目包括在妊娠34-42周之间入组时的GMA数据，最多加上1-2个视频 预测年龄（足月后10-14周）和12个月和/或24个月时的发育结果。 目标2）使用Hammersmith婴儿提供纵向评估的共享数据集 神经系统检查（HINE），可用于确定HINE是否对随时间变化敏感。 创新的纵向干预研究，如母项目，开始评估干预措施 在出生后的最初几周开始，目的是降低发育迟缓的发生率和严重程度 和脑瘫。父项目使用HINE作为确定子项目是否具有CP的一个组件。 然而，这个前瞻性队列足够大，可以使用HINE评估随时间变化的敏感性 这是以前没有评估过的。因此，从患有或未患糖尿病的婴儿中获得的研究数据是否至关重要？ 具有CP高风险的人可以公开访问，以便进行二次分析，如工具验证。 目标3）公布高质量的保真度数据，可与2009年开始的其他干预措施进行比较。 NICU或14周龄时。康复干预有很长的历史，不监测保真度。 该数据集包括20%干预访问的视频，已对其进行评分以衡量依从性 干预的原则。其他团队将能够使用代码手册中包含的指导 沿着视频，以提高自己的保真度评价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Reproresearch， 她是数据库启动团队的成员，她放大了以前对制作这个令人难以置信的数据集的兴趣 可供公众使用。虽然流行病学的地方数据可以提供一些深入了解的需求或预测因素， 婴儿结局，主要纵向收集的数据可能更具临床意义， 准确这些数据将有助于更好地了解儿童的发展和康复。