Transfusion of Prematurity Early School Age Follow-up (TOP 5) DCC

早产儿输血早期学龄随访（TOP 5）DCC

基本信息

批准号：
10247622
负责人：
Abhik Das
金额：
$ 100.56万
依托单位：
RESEARCH TRIANGLE INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-09-20 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10247622
关键词：
5 year old Academic skills Age Age-Months Anemia Behavioral Biometry Birth Weight Brain Caring Child Childhood Clinical Clinical Management Clinical Research Cognitive Cohort Studies Collaborations Companions Custom Data Data Coordinating Center Data Reporting Data Set Development Emotional Enrollment Ensure Environment Erythrocyte Transfusion Event Exposure to Extremely Low Birth Weight Infant Family Follow-Up Studies Funding Gestational Age Goals Hemoglobin Hemoglobin concentration result Home Human Resources Impairment Infant Information Dissemination Informed Consent Infrastructure Intensive Care Units International Knowledge Lead Leadership Learning Disabilities Letters Life Logistics Longterm Follow-up Low Birth Weight Infant Manuals Mental disorders Monitor Morbidity - disease rate Motor Multicenter Neonatal Research Network Multicenter Studies National Heart, Lung, and Blood Institute National Institute of Child Health and Human Development Neonatal Neonatology Network Infrastructure Neurodevelopmental Impairment Neurologic Neurological outcome Newborn Infant Outcome Outcome Study Outcomes Research Parents Patients Performance Phase Population Premature Infant Principal Investigator Process Productivity Protocols documentation Randomized Randomized Controlled Trials Recording of previous events Records Reporting Research Research Infrastructure Research Personnel Resources Running Safety Sample Size School-Age Population Schools Statistical Data Interpretation Structure Survival Rate System Time Training Transfusion United States National Institutes of Health Update Visit academic preparation base clinical center clinical practice cognitive function cognitive skill cohort data management data quality design electronic data capture system evidence base experience flexibility follow-up functional outcomes improved infant outcome meetings neurodevelopment neuronal circuitry payment premature randomized trial skills success tool

5 year old Academic skills Age Age-Months Anemia Behavioral Biometry Birth Weight Brain Caring Child Childhood Clinical Clinical Management Clinical Research Cognitive Cohort Studies Collaborations Companions Custom Data Data Coordinating Center Data Reporting Data Set Development Emotional Enrollment Ensure Environment Erythrocyte Transfusion Event Exposure to Extremely Low Birth Weight Infant Family Follow-Up Studies Funding Gestational Age Goals Hemoglobin Hemoglobin concentration result Home Human Resources Impairment Infant Information Dissemination Informed Consent Infrastructure Intensive Care Units International Knowledge Lead Leadership Learning Disabilities Letters Life Logistics Longterm Follow-up Low Birth Weight Infant Manuals Mental disorders Monitor Morbidity - disease rate Motor Multicenter Neonatal Research Network Multicenter Studies National Heart, Lung, and Blood Institute National Institute of Child Health and Human Development Neonatal Neonatology Network Infrastructure Neurodevelopmental Impairment Neurologic Neurological outcome Newborn Infant Outcome Outcome Study Outcomes Research Parents Patients Performance Phase Population Premature Infant Principal Investigator Process Productivity Protocols documentation Randomized Randomized Controlled Trials Recording of previous events Records Reporting Research Research Infrastructure Research Personnel Resources Running Safety Sample Size School-Age Population Schools Statistical Data Interpretation Structure Survival Rate System Time Training Transfusion United States National Institutes of Health Update Visit academic preparation base clinical center clinical practice cognitive function cognitive skill cohort data management data quality design electronic data capture system evidence base experience flexibility follow-up functional outcomes improved infant outcome meetings neurodevelopment neuronal circuitry payment premature randomized trial skills success tool

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项目摘要

Project Summary Up to 95% of premature infants undergo red blood cell (RBC) transfusion while in the intensive care unit, yet it is unknown whether more restrictive or more liberal transfusions will lead to optimal brain development. The Transfusion of Prematures (TOP) Trial is a multi-center study funded by the NHLBI and supported by the NICHD Neonatal Research Network (NRN). The primary objective of the TOP Trial is to assess survival and rates of neurodevelopmental impairment at 22-26 months corrected age in extremely low birth weight (ELBW) infants that are randomized to either liberal or restrictive RBC transfusion thresholds. The trial began enrollment in December 2012 and reached the target sample size of 1,824 infants on time in April 2017. Although major deficits in motor and cognitive function may be detected at 22-26 months of age, these infants are too young to assess cognitive, behavioral, and coordination skills that, if impaired, can lead to problems with academic skills, motor performance or adaptive functioning in home or school environments, conditions that are far more prevalent in this population and create substantial morbidity for the children and their families. Because optimal transfusion management is a critical knowledge gap in neonatology, the currently proposed TOP 5 Study will assess functional neurodevelopmental outcomes of infants randomized to two different transfusion thresholds in the TOP Trial at 5 years corrected age. The TOP 5 Study Clinical Coordinating Center (CCC) is led by Co-PIs Dr. Peg Nopoulos, who has a ten-year history of studying the outcomes of premature infants exposed to liberal or restrictive transfusion, and Dr. Sara DeMauro, who has extensive experience conducting multicenter outcomes studies in collaboration with the NICHD NRN and the Data Coordinating Center (DCC) at RTI International. The DCC PI Dr. Abhik Das also leads the DCC for the NICHD NRN. The NRN has a superb track record in school-age outcomes research and history of productive collaboration with NHLBI. Thus, the TOP 5 Study has been thoughtfully designed to leverage existing successful research infrastructure, relationships, and resources in order to reduce redundancy and ensure success. The results of the TOP 5 study will provide evidence about which approach to neonatal transfusion (liberal or restrictive) minimizes damage to vulnerable neuronal circuits and, in turn, which transfusion strategy will improve both short and long-term outcomes for these vulnerable premature infants.

项目摘要在重症监护室中，多达95％的早产婴儿经历了红细胞（RBC）输血，但尚不清楚更多的限制性或更宽松的输血会导致最佳的大脑发展。这预先提出（顶级）试验的输血是一项由NHLBI资助的多中心研究，并由 NICHD新生儿研究网络（NRN）。最高试验的主要目的是评估生存和在极低的出生体重（ELBW）的22-26个月校正年龄时，神经发育障碍的发生率（ELBW）随机分配给自由或限制性RBC输血阈值的婴儿。审判开始了 2012年12月的入学人数在2017年4月达到了1,824名婴儿的目标样本量。尽管可以在22-26个月大的时候检测到运动和认知功能的主要缺陷，但这些婴儿太年轻，无法评估认知，行为和协调能力，如果受损，可能会导致问题在家庭或学校环境中，具有学术技能，运动表现或自适应功能，条件这在这个人群中更为普遍，并为儿童及其家人带来了大量的发病率。由于最佳输血管理是新生儿学的关键知识差距前5名研究将评估随机分为两个不同的婴儿的功能性神经发育结果在5岁时的最高试验中，输血阈值。前5名研究临床协调中心（CCC）由Co-Pis Dr. Peg Nopoulos领导，他有十年研究暴露于自由或限制性输血的早产婴儿和萨拉博士的历史 Demauro，他在与与该研究合作进行多中心成果研究的丰富经验 RTI International的Nichd NRN和数据协调中心（DCC）。 DCC PI ABHIK DAS博士领导NICHD NRN的DCC。 NRN在学院成果研究和与NHLBI合作的历史。因此，排名前五的研究经过精心设计利用现有的成功研究基础设施，关系和资源来减少冗余并确保成功。前5名研究的结果将提供证据新生儿输血的方法（自由或限制性）最大程度地减少对脆弱神经元的损害电路，反过来，输血策略将改善短期和长期结局这些脆弱的早产婴儿。