Early Identification of Developmental Disorders in Infants

描述（由申请人提供）：由于产科和新生儿护理的改善，以及围产期死亡率的相关降低，以及体外受精程序相关风险的增加，早产（经后年龄< 37周）极低出生体重（<1，500 g）婴儿的数量正在增加[2]。在美国每年出生的约50，000名低出生体重婴儿中，约85%存活。这些婴儿患长期发育障碍的风险增加，约5-15%表现出严重的神经发育障碍（例如，大脑性麻痹、智力迟钝）和另外25-50%表现出轻度至中度神经发育障碍（例如，[59]第95话失败SBIR第一阶段资助申请涉及在很小的年龄检测发育障碍。评估低出生体重、不良妊娠或复杂分娩对婴儿中枢神经系统（CNS）结构和功能及其发育的影响，对于获得行为和神经系统状态的有效估计、记录急性效应的恢复、预测后续结局以及针对任何注意到的问题提出具体干预策略非常重要。虽然脑成像，如颅超声，计算机断层扫描和磁共振成像，可以记录结构性脑损伤，评估婴儿的内源性（即，自发的）运动模式，称为“全身运动”（GM），提供了一种评估CNS功能的方法。在过去的25年里，大量的文献表明，运动，首先是胎儿，随后是幼儿，具有很强的临床意义，作为脑功能和功能障碍的指标。目前，GMs的评估是基于视频记录的婴儿运动模式的完形评估。GM的评估是标准神经学检查、原始反射特征以及肌肉力量和张力评估的有用辅助手段。然而，视频记录的使用并不理想，因为它繁琐、主观、劳动密集且昂贵，需要经过专门训练的从业者来评估所存储的线的图像序列。为了克服这些局限性，我们建议开发一般运动的婴儿神经系统疾病的识别（GEMINI）系统，一个低成本的工具，客观和自动评估婴儿GM在医院和非设置。GEMINI系统将利用巴伦公司最近获得专利的[73]六自由度无线运动监测能力和复杂的信号处理来识别GM的关键定性和定量属性，从而自动评估GM。根据拟议的多阶段研究计划，将获得必要的知识，以实现低成本，低姿态的GEMINI产品，可以可靠地执行所需的歧视任务，并作为一个有价值的研究工具，记录和更好地了解其他疾病，如自闭症的运动和运动前兆。运动失调的识别可以导致早期干预（例如，发育物理治疗）和治疗策略，旨在促进正常的运动模式，在关键时期的早期中枢神经系统可塑性。GEMINI工具还将使转基因评估的婴儿在农村地区，获得专门培训的从业人员是不可用的。此外，该工具将有助于研究提供客观的结果措施，以评估干预措施的有效性，也可能是有用的，在确定的基本过程，确定正常和异常的运动结果。

DESCRIPTION (provided by applicant): Due to improvements in obstetrical and neonatal care, and an associated decrease in perinatal mortality, as well as increased risks associated with in vitro fertilization procedures, the number of preterm (< 37 weeks postmenstrual age) very low birth weight (< 1,500 g) infants born is growing [2]. Of the approximately 50,000 infants born yearly in the United States with a low birth weight, approximately 85% survive. These infants have an increased risk of long-term developmental disabilities, with approximately 5-15% exhibiting major neurodevelopmental disabilities (e.g., cerebral palsy, mental retardation) and an additional 25-50% exhibiting mild to moderate neurodevelopmental disabilities (e.g., school failure) [59, 95]. This SBIR Phase I grant application is concerned with the detection of developmental disorders at a very early age. Assessment of the consequences of low birth weight, adverse pregnancies, or complicated births on the structure and function of an infant's central nervous system (CNS) and its development is important for ob- taining valid estimates of behavior and neurological status, documenting recovery from acute effects, predicting subsequent outcome, and suggesting specific intervention strategies for any problems noted. Although brain imaging, such as cranial ultrasound, computed tomography, and magnetic resonance imaging, can document structural brain damage, assessment of infants' endogenously-generated (i.e., spontaneous) movement patterns, known as "general movements" (GMs), provides a method by which to assess CNS function. In the past 25 years, an extensive literature has shown that motility, first of the fetus and subsequently of the young infant, has strong clinical significance as an indicator of brain function and dysfunction. Presently, assessment of GMs is based on the Gestalt evaluation of video-recorded infant movement patterns. Assessment of GMs is a useful adjunct to the standard neurological examination, primitive reflex profile, and assessment of muscle strength and tone. However, use of video recording is not ideal since it is tedious, subjective, labor intensive, and expensive, requiring specially-trained practitioners to evaluate stored image sequences of line. To overcome these limitations, we propose to develop the General Movements for the Identification of Neurological disorders in Infants (GEMINI) system, a low-cost tool for objectively and automatically assessing infant GMs in hospital and non settings. The GEMINI system will exploit Barron Associates' recently-patented [73] six degrees-of-freedom wireless motion monitoring capability and sophisticated signal processing to identify the key qualitative and quantitative attributes of GMs, and thereby automate the assessment of GMs. Based on the proposed multi-phase research program, the requisite knowledge will be obtained to enable realization of a low-cost, low-profile GEMINI product that can reliably perform the required discrimination tasks and serve as a valuable research tool in documenting and better understanding movements and movement precursors for other disorders, such as autism. Identification of movement dysregulation can lead to early interventions (e.g., developmental physical therapy) and treatment strategies aimed at facilitating normal movement patterns during the critical period of early CNS plasticity. The GEMINI tool will also enable GM assessment of infants in rural areas where access to specially- trained practitioners is unavailable. Furthermore, the tool will be helpful in research studies for providing objective outcome measures by which to evaluate the effectiveness of interventions, and may also be useful in identifying the underlying process that determines normal and abnormal motor outcomes.