Development of a Therapeutic Device to Improve Speech Sound Differentiation in Preterm Infants

开发一种改善早产儿语音​​分化的治疗装置

• 批准号: 10697501
• 负责人: Dean R Koch
• 金额: $ 119.15万
• 依托单位: THRIVE NEUROMEDICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-03 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697501
• 关键词: 2 year old; Active Learning; Address; Adult; Affect; Age; Auditory; Auditory Perception; Auditory system; Behavior assessment; Birth; Brain; Calibration; Caregivers; Caring; Child; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Complex; Data; Development; Developmental Delay Disorders; Devices; Economics; Electroencephalography; Ensure; Environment; Exposure to; Family; Foundations; Funding; Geography; Hearing; Hospitalization; Hospitals; Human; Impairment; Incubators; Infant; Infection Control; Intervention; Justice; Language; Language Delays; Language Development; Learning; Loudness; Marketing; Measurement; Measures; Mothers; Neonatal Intensive Care Units; Newborn Infant; Noise; Nurses; Outcome; Outcome Measure; Pacifiers; Parents; Pattern; Phase; Physiological; Policies; Population; Pregnancy; Premature Birth; Premature Infant; Process; Protocols documentation; Randomized; Randomized, Controlled Trials; Reading; Recommendation; Research; Safety; Schedule; School-Age Population; Speech; Speech Sound; Stimulus; Structure; System; Team Nursing; Technology; Testing; Therapeutic; Time; United States; Universities; Uterus; Voice; auditory processing; auditory stimulus; awake; brain based; clinical practice; cognitive development; design; early childhood; effective intervention; empowerment; experience; family support; health determinants; high risk; improved; improved outcome; infancy; infection risk; innovation; intervention effect; language outcome; language processing; manufacture; medically necessary care; neural; neural circuit; neurosensory; peer; premature; pressure; product development; prototype; psychologic; research and development; response; sensor; social; social health determinants; sound; standard care; sucking; targeted treatment; verbal

PROJECT DESCRIPTION Thrive Neuromedical LLC proposes to develop, test, and gain FDA clearance to market a therapeutic device to improve speech sound differentiation in preterm infants hospitalized in the neonatal intensive care unit (NICU). During this project we will complete development of the smallTalk NICU Active system and conduct a clinical trial to prove its efficacy in improving speech sound differentiation among hospitalized preterm infants. The device is designed to be used at an age equivalent to 32 weeks of gestation or older and to integrate readily into clinical practice for use by nurses and therapists staffing Level II to Level IV NICUs. Prototype research and development met or exceeded the stated technical milestones. In 2020, preterm birth affected 1 of every 10 infants born in the United States. Large numbers of infants are born daily requiring NICU stays. This NICU stay, while medically necessary, can result in impairments in the developing infant brain. In particular, there is a lack of exposure to infant directed parental or caretaker voice. It is known that exposure to infant directed speech, which is different from adult directed speech, is developmentally important for optimal, early brain development. The ability to differentiate speech sounds is a prerequisite for developing more complex receptive language. Infant directed speech, ideally when sought by an attentive infant, stimulates brain wiring and attunes the infant’s brain to speech sounds. For the developing infant brain, “plasticity” for language learning peaks during infancy, as the baby develops neural connections that enable differentiating their native language’s speech sounds. These connections are the foundation for more complex brain functions. Due in part to their time in NICU care, preterm infants have poorer receptive language scores at age two. A majority require speech and language intervention prior to school age. There is currently no intervention that addresses the problem of poor speech sound differentiation arising from NICU hospitalization, a period when the greatest potential for improving outcomes exists. This proposal seeks funding for the final product development and rigorous testing of the smallTalk NICU Active system. We will manufacture a small batch of the devices to support a proposed randomized clinical study at Emory University, the results of which will be submitted to FDA for clearance to market the innovative device.

项目描述 Thrive Neuromedical LLC 提议开发、测试一种治疗设备并获得 FDA 批准上市 改善新生儿重症监护病房住院的早产儿的语音辨别能力 （新生儿重症监护病房）。在这个项目期间，我们将完成smallTalk NICU Active系统的开发，并进行 临床试验证明其在改善住院早产儿言语声音分化方面的功效。 该设备设计为在相当于妊娠 32 周或以上的年龄使用，并集成 易于进入临床实践，供二级至四级 NICU 的护士和治疗师使用。原型 研究和开发达到或超过了规定的技术里程碑。 2020年，早产影响1 每 10 个在美国出生的婴儿。每天都有大量婴儿出生，需要入住新生儿重症监护室。 住院重症监护室虽然具有医疗必要性，但可能会导致婴儿大脑发育受损。在 特别是，缺乏对婴儿直接的父母或看护者的声音的接触。据了解，曝光 婴儿定向言语与成人定向言语不同，对于婴儿的发育非常重要 最佳的早期大脑发育。区分语音的能力是发展的先决条件 更复杂的接受语言。婴儿定向言语，最好是当专心的婴儿寻求时， 刺激大脑线路并使婴儿的大脑适应语音。对于正在发育的婴儿大脑来说， 语言学习的“可塑性”在婴儿期达到顶峰，因为婴儿会发展出能够实现语言学习的神经连接。 区分他们母语的语音。这些连接是更复杂的基础 大脑功能。早产儿接受性语言得分较低，部分原因在于他们在新生儿重症监护室 (NICU) 护理中的时间 两岁时。大多数人在学龄前需要言语和语言干预。目前没有 解决新生儿重症监护病房(NICU) 引起的语音辨别能力差问题的干预措施 住院期间，这是改善结果的最大潜力的时期。该提案寻求 为 SmallTalk NICU Active 系统的最终产品开发和严格测试提供资金。我们将 制造一小批设备以支持埃默里大学拟议的随机临床研究 大学，其结果将提交给 FDA 批准该创新设备的上市。