Detection and Quantification of Neonatal Intraventricular Hemorrhage

新生儿脑室内出血的检测和定量

基本信息

批准号：
8539858
负责人：
ROSALIND J SADLEIR
金额：
$ 32.97万
依托单位：
ELECTRICAL GEODESICS, INC.
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：
2012-09-15 至 2016-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8539858
关键词：
Accounting Achievement Acute Apnea Blindness Blood Blood Coagulation Factor Blood Platelets Blood Pressure Blood Volume Brain Brain Injuries Cardiovascular system Central venous pressure Cerebral Palsy Cerebrovascular Circulation Chronic Clinical Clinical Management Complex Computer software Creation of ventriculo-peritoneal shunt Data Detection Device or Instrument Development Devices Diagnosis Diagnostic Early Diagnosis Early identification Electrodes Electroencephalography Ensure Environment Erythrocytes Etiology Exhibits Factor VIIa Future Goals Head Hemorrhage Homeostasis Hospitals Hour Hydrocephalus Hypercapnia Hypotension Image Imaging Device Impaired cognition Incidence Infant Investigation Ischemic-Hypoxic Encephalopathy Life Liquid substance Live Birth Measurement Mechanical ventilation Medical Metabolic acidosis Methods Modeling Monitor Morbidity - disease rate Morphologic artifacts Neonatal Neonatal Brain Injury Neonatal Intensive Care Neurodevelopmental Deficit Neurologic Neurological outcome Pallor Pathology Patients Periventricular Leukomalacia Pharmaceutical Preparations Physiologic Monitoring Physiological Physiology Premature Birth Premature Infant Prospective Studies Research Retrospective Studies Risk Safety Seizures Severities Speed Stress Supportive care System Technology Testing Time Ultrasonography United States Variant blood product care delivery deafness design disability electric impedance improved intraventricular hemorrhage meetings monitoring device neonate novel outcome forecast phase 1 study pilot trial premature respiratory subventricular zone tomography tool

项目摘要

DESCRIPTION (provided by applicant): Clinical neonatal monitoring is also vital for diagnosis and prognosis of acute pathologies. One such pathology, neonatal intraventricular hemorrhage (IVH), is a common consequence of premature birth, with approximately 30 percent of infants weighing less than 1500 g having some degree of bleeding. While some neonates exhibit clear outward signs related to IVH such as apnea, pallor, seizures and metabolic acidosis, up to 50 percent of IVHs may be clinically silent. Large IVHs are associated with unfavorable neurologic outcomes. Adverse neurodevelopmental sequelae include cerebral palsy, seizures, posthemorrhagic hydrocephalus (which may require a ventriculoperitoneal shunt), blindness, deafness, and cognitive impairment (Hintz and O'Shea 2008, Goldenberg and Jobe 2001). Although ultrasound is almost universally employed as a retrospective screen at 7 days of life, 50 percent of IVHs occur during the first day of life (and 75 percent in the first 3 days). Further ultrasound is less sensitive to Grade II IVHs (Babcock et al 1982, Mack et al 1981), and its availability as a diagnostic tool is operator dependent, with limited hours of availability. The variation in clinical presentation and need to intervene early stresses the need for a simple to interpret device that can monitor and detect developing IVHs in real time, allowing administration of supportive therapies (blood products) or treatments (activated factor VII). While the clinical consequences of IVH are severe, little is known about its exact etiology. Many physiologic disturbances (e.g., loss of cerebral blood flow autoregulation, increased central venous pressure, hypotension) have been associated with IVHs through retrospective studies, but exact cause-effect relationships between these parameters do not exist (Ballabh 2010). Further, causal connections between the incidence of IVH and neuroelectric abnormalities observed in IVH such as positive rolandic sharps and seizures have not been established. In this project we propose developing a device that can be used in a future comprehensive investigation of the connections between circulatory and neuroelectric abnormalities in the context of IVH. If it is successful, this device may not only aid understanding of the underlying mechanisms leading to IVH, but also be of use in early identification of developing bleeds, and combined with appropriate therapies, limiting the extent of bleeding and other brain damage. Monitoring of premature infants poses unique challenges, one of these being the ideal of non-invasive bedside monitoring. We have previously developed an electrical imaging device that uses an EEG- like electrode array to continuously monitor and quantify small (< 0.5 ml) blood accumulations in the neonatal ventricles. We propose developing a monitoring device that can simultaneously gather EEG and bleeding status data using the same electrode array, with minimal impact on clinical management. Data from the device will be made available in a manner that also allows comparison with other physiological monitoring systems.

描述（由申请人提供）：临床新生儿监测对于急性病理的诊断和预后也至关重要。其中一种病理学是新生儿脑室内出血 (IVH)，是早产的常见后果，大约 30% 体重低于 1500 克的婴儿有一定程度的出血。虽然一些新生儿表现出与 IVH 相关的明显外在体征，例如呼吸暂停、面色苍白、癫痫发作和代谢性酸中毒，但高达 50% 的 IVH 可能在临床上是无症状的。较大的 IVH 与不良的神经系统结果相关。不良的神经发育后遗症包括脑瘫、癫痫、出血后脑积水（可能需要脑室腹腔分流术）、失明、耳聋和认知障碍（Hintz 和 O'Shea 2008，Goldenberg 和 Jobe 2001）。尽管超声几乎普遍用作出生后 7 天的回顾性筛查，但 50% 的 IVH 发生在出生后第一天（75% 发生在出生后的前 3 天）。进一步的超声检查对 II 级 IVH 不太敏感（Babcock 等人 1982 年，Mack 等人 1981 年），并且其作为诊断工具的可用性取决于操作员，且可用时间有限。临床表现的变化和早期干预的需要强调需要一种易于解释的设备，该设备可以实时监测和检测正在发生的 IVH，从而允许进行支持疗法（血液制品）或治疗（激活的因子 VII）。虽然 IVH 的临床后果很严重，但对其确切病因知之甚少。通过回顾性研究，许多生理紊乱（例如脑血流自动调节丧失、中心静脉压升高、低血压）与 IVH 相关，但这些参数之间不存在确切的因果关系（Ballabh 2010）。此外，IVH 的发生率与 IVH 中观察到的神经电异常（例如阳性罗兰尖音和癫痫发作）之间的因果关系尚未确定。在这个项目中，我们建议开发一种设备，可用于未来对 IVH 背景下循环和神经电异常之间的联系进行全面研究。如果成功，该装置不仅可以帮助理解导致 IVH 的潜在机制，还可以用于早期识别正在发生的出血，并与适当的治疗相结合，限制出血和其他脑损伤的程度。早产儿的监测提出了独特的挑战，其中之一就是理想的无创床边监测。我们之前开发了一种电子成像设备，它使用类似脑电图的电极阵列来连续监测和量化新生儿心室中的少量（< 0.5 ml）血液积聚。我们建议开发一种监测设备，可以使用相同的电极阵列同时收集脑电图和出血状态数据，对临床管理的影响最小。来自该设备的数据将以允许与其他生理监测系统进行比较的方式提供。