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Transfusion-Associated Brain Improvement (TABI) trial - CCC

输血相关大脑改善 (TABI) 试验 - CCC

基本信息

批准号：
8269508
负责人：
EDWARD F BELL
金额：
$ 18.45万
依托单位：
CHILDREN'S HOSP OF PHILADELPHIA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2017-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8269508
关键词：
Accounting Address Age Age-Months Americas Apnea Benefits and Risks Bilateral Hearing Loss Birth Birth Weight Blood Banks Blood Tests Blood Transfusion Bone Marrow Brain Bronchopulmonary Dysplasia Cephalic Cerebral Palsy Cessation of life Child Childhood Classification Clinical Clinical Trials Cochlear Implants Cognitive Conflict (Psychology)Consent Cost-Benefit Analysis Data Data Coordinating Center Development Developmental Disabilities Disabled Persons Environment Epilepsy Erythrocyte Transfusion Erythrocytes Extremely Low Birth Weight Infant Eye Feeds Follow-Up Studies Gestational Age Head circumference Healthcare Hematocrit procedure Hemoglobin Hemoglobin concentration result Hydrocephalus Immature Bone Impairment Incidence Individual Infant Infant Development Influentials Intensive Care Intention Iowa Language Lead Length Length of Stay Long-Term Survivors Lung diseases Masks Medicine Microcephaly Mission Morbidity - disease rate Motor Movement Muscle Tonus National Heart, Lung, and Blood Institute National Institute of Child Health and Human Development Necrotizing Enterocolitis Neonatal Neurocognitive Neurodevelopmental Impairment Neurologic Neurological outcome Newborn Infant Ophthalmologist Outcome Outcome Study Pathway interactions Periventricular Leukomalacia Physicians Pregnancy Premature Birth Premature Infant Randomized Randomized Controlled Trials Regimen Research Research Personnel Retinopathy of Prematurity Risk Shunt Device Site Societies Staging Survival Rate Survivors Time Training Transfusion Ultrasonography Variant Vision Visual Acuity Weight Work abstracting arm base blood product central nervous system injury clinical practice clinically relevant design disability economic cost evidence based guidelines experience follow-up handicapping condition hearing impairment improved innovation intraventricular hemorrhage motor impairment neonate premature primary outcome randomized trial secondary outcome tool

项目摘要

DESCRIPTION (provided by applicant): Significance: Prematurity is a major health care problem in America, with more than 10,000 babies born preterm (less than 37 completed weeks of pregnancy) every week in the US. The economic cost to society of preterm birth in 2005 was more than $26 billion. Long-term outcomes of survivors often include neuro- developmental disabilities. In surviving Extremely Low Birth Weight (ELBW) babies born at less than 1000 g BW, 47% had low neurocognitive assessment (MDI score less than 70) at 18 months, indicating severe handicaps. During intensive care, these babies need many blood tests and have an immature bone marrow, thus requiring frequent blood transfusions. However, what hemoglobin levels to best transfuse at, as well as the long-term benefits and risks of Red Blood Cell (RBC) transfusion in ELBW babies, are largely unknown. Investigators and Prior Work: Only two previous trials addressed whether to transfuse at high or low hemoglobin thresholds in ELBW babies. They were done by the two clinical PIs (Kirpalani, Bell), but produced conflicting results as to whether higher hemoglobins might improve neurological outcome. If this is true, a simple therapy of RBC transfusion could be used to maintain higher hemoglobin, with potential major benefit for ELBW newborns. This question needs to be examined in a new trial, which we propose in this application. Drs. Kirpalani and Bell have joined forces with Drs Das and Brambilla, PI and Alternate PI at the Data Coordinating Center, with vast experience in clinical trials in ELBW neonates, as well as transfusion medicine. Innovation: Many neonatologists have shifted toward using lower hemoglobin thresholds for transfusion, based largely on retrospective data. We propose a randomized controlled trial (RCT) to evaluate the potential benefits of transfusing to maintain higher hemoglobin. The need to assess long-term outcomes of randomized trials is compelling in the newborn. Our primary outcome is a composite of death or neurodevelopmental impairment at 18-22 months of corrected age. Finally, the proposed study will account for differing blood bank practices and differences in dispensed products across multiple study sites and will adjust for variation in the hematocrit of dispensed RBCs by site. Approach: We will perform a RCT in ELBW babies asking: "Should babies in the neonatal ICU get transfused at a higher hemoglobin threshold or a lower one, in order to have better brain development at 18-22 months of age?" The question is highly relevant to the mission of the NHLBI. Trial results could radically alter blood transfusion practices in the neonatal ICU. Environment: We have partnered with the NICHD Neonatal Research Network (NRN) and its 18 clinical centers. We believe this trial is feasible and can be most efficiently conducted within the NRN centers, which have successfully completed many influential clinical trials in preterm infants that have often changed clinical practice. PUBLIC HEALTH RELEVANCE: Long-term outcomes of preterm infants who weigh less than 1000 g at birth are poor, and their disability rates are high. Although virtually all such infants are transfused, some physicians transfuse more than others, because evidence based guidelines are very broad. Since higher hemoglobin thresholds for transfusion may be beneficial to long-term neurocognitive outcomes at 18-22 months, this randomized trial is designed to assess whether keeping hemoglobins higher will reduce death or neurodisability in survivors. (End of Abstract)

描述（由申请人提供）：