Noninvasive, Optoacoustic Monitoring of Cerebral Circulation in Preterm Neonates

早产儿脑循环的无创光声监测

• 批准号: 8524980
• 负责人: Graham Randall
• 金额: $ 16.68万
• 依托单位: NONINVASIX, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2016-04-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8524980
• 关键词: Acceleration; Address; Adult; Affect; Anterior; Biomedical Engineering; Blood; Blood flow; Blood specimen; Body Weight; Brain; Businesses; Calibration; Cardiopulmonary Bypass; Cephalic; Cerebral Ischemia; Cerebrovascular Circulation; Cerebrum; Characteristics; Clinical; Clinical Nurse Specialists; Clinical Research; Cognitive; Consult; Department of Defense; Development; Devices; Doppler Ultrasound; Emerging Technologies; Encephalopathies; Etiology; Faculty; Free Radicals; Funding; Goals; Gold; Image; Impaired cognition; Infant; Infant Mortality; Inflammation; Intervention; Ischemia; Laboratories; Legal patent; Licensing; Low Birth Weight Infant; Magnetic Resonance; Magnetic Resonance Imaging; Measurement; Measures; Medical; Methodology; Monitor; Motor; Near-Infrared Spectroscopy; Neonatal; Neonatal Intensive Care Units; Newborn Infant; Normal Range; Optics; Oxygen; Patients; Perfusion; Phase; Physiological; Play; Positron-Emission Tomography; Premature Infant; Probability; Process; Research Personnel; Risk; Role; Services; Severities; Structure of fontanel of skull; Superior sagittal sinus; System; Techniques; Technology; Testing; Texas; Thick; Traumatic Brain Injury; United States National Institutes of Health; Universities; Venous; Very Low Birth Weight Infant; X-Ray Computed Tomography; base; bone; commercialization; design; disability; engineering design; experience; improved; in vivo; innovation; mature animal; meetings; multidisciplinary; neonate; neurobehavioral; postnatal; premature; prognostic; programs; prototype; public health relevance; response

DESCRIPTION (provided by applicant): Premature, very-low-birth-weight (VLBW; d1500 g) and low-birth-weight (LBW; 1500-2499 g) infants are at increased risk for long-term encephalopathy. 25-50% of the 63,000 VLBW infants born annually in the U.S. have major long-term cognitive or neurobehavioral deficits. Postnatal cerebral ischemia appears to play an important role in long-term cognitive sequelae. Unfortunately, the ability of the cerebral vasculature of LBW and VLBW neonates to maintain adequate cerebral blood flow is poorly understood. Although important, provocative clinical studies have been performed with classical Kety-Schmidt methodology, Doppler ultrasound, positron emission tomography, perfusion computed tomography, magnetic resonance imaging and near-infrared spectroscopy, there is currently no technique for easily, repeatedly and noninvasively monitoring or measuring cerebral circulatory adequacy in LBW or VLBW infants. Our start-up company, Noninvasix, recently demonstrated in VLBW and LBW infants that optoacoustic technology permits easy, accurate, direct noninvasive measurement of cerebral venous blood oxygen saturation in the superior sagittal sinus (SSSSO2) through the open anterior fontanelle. SSSSO2 measures the ability of cerebral blood flow to meet cerebral oxygen demand; in adults with traumatic brain injury cerebral venous saturations less than 50%, suggesting that cerebral blood flow does not meet cerebral oxygen demand, have ominous prognostic implications. Having established the proof-of-concept for optoacoustic SSS monitoring of neonates, we now propose in this Phase I application to refine that technique as a major step toward commercialization of a device for intermittent measurements and continuous monitoring of neonatal cerebral perfusion. In this Phase I proposal, based on our laboratory prototype, Noninvasix will collaborate with The University of Texas Medical Branch, which co-owns Noninvasix with two faculty who are inventors and investigators in this proposal, and Cooper Consulting Services (CCS), an engineering design firm, to iteratively design and build a clinical prototype neonatal interface and a user interface and test it in post- delivery neonates. We will produce and test the clinical prototype (Fig. 1 in Innovation section) by progressing through the following specific aims: Specific Aim 1. To develop a clinical prototype patient interface for our noninvasive optoacoustic monitor that will accurately determine SSSSO2 in neonates. Specific Aim 2. To develop a clinical user interface for our noninvasive optoacoustic monitor that will facilitate rapid assessment of SSSSO2 in neonates intermittently or continuously in the Neonatal Intensive Care Unit. Specific Aim 3. Preliminarily establish in vivo in neonates the range of SSSSO2 to be expected in infants of varying body weight (10-12 LBW neonates and 10-12 VLBW neonates).

描述（由申请人提供）：早产、极低出生体重（VLBW; d1500 g）和低出生体重（LBW; 1500 - 2499 g）婴儿发生长期脑病的风险增加。在美国每年出生的63，000名VLBW婴儿中，有25 - 50%患有严重的长期认知或神经行为缺陷。出生后脑缺血似乎在长期认知后遗症中起重要作用。不幸的是，对LBW和VLBW新生儿的脑血管系统维持足够脑血流量的能力知之甚少。虽然已经用经典的Kety-Schmidt方法、多普勒超声、正电子发射断层扫描、灌注计算机断层扫描、磁共振成像和近红外光谱进行了重要的、有争议的临床研究，但目前还没有一种技术可以简单、重复和无创地监测或测量LBW或VLBW婴儿的脑循环充分性。我们的初创公司Noninvasix最近在极低出生体重和低出生体重婴儿中证明，光声技术可以通过开放的前上级矢状窦（SSSSO 2）轻松、准确、直接地无创测量脑静脉血氧饱和度。SSSSO 2测量脑血流满足脑需氧量的能力;在创伤性脑损伤成人中，脑静脉饱和度低于50%，表明脑血流不能满足脑需氧量，具有不良预后意义。在建立了新生儿光声SSS监测的概念验证后，我们现在建议在此I期申请中完善该技术，作为间歇测量和连续监测新生儿脑灌注的设备商业化的重要一步。在这个第一阶段的提案中，基于我们的实验室原型，Noninvasix将与德克萨斯大学医学分支合作，该分支与两名教师共同拥有Noninvasix，他们是该提案的发明者和研究者，以及库珀咨询服务公司（CCS），一家工程设计公司，迭代设计和构建临床原型新生儿界面和用户界面，并在分娩后的新生儿中进行测试。我们将通过以下具体目标生产和测试临床原型（创新部分中的图1）：具体目标1。为我们的无创光声监测仪开发一种临床原型患者界面，该界面将准确确定新生儿的SSSSO2。 具体目标2。为我们的无创光声监护仪开发一个临床用户界面，以促进在新生儿重症监护室间歇或连续快速评估新生儿SSSSO2。 具体目标3。在新生儿体内初步确定不同体重婴儿（10 - 12 LBW新生儿和10 - 12 VLBW新生儿）的预期SSSSO 2范围。