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、测试并获得FDA批准，以销售一种治疗器械 改善新生儿重症监护病房住院早产儿的语音辨别 （新生儿重症监护病房）。在本项目期间，我们将完成smallTalk NICU Active系统的开发，并进行 临床试验，以证明其在改善住院早产儿语音分化方面的有效性。 该器械设计用于相当于32周或更大的妊娠期， 易于进入临床实践，供配备II级至IV级NICU的护士和治疗师使用。原型 研究和开发达到或超过了所述的技术里程碑。2020年，早产影响1 在美国出生的每10个婴儿中，每天都有大量婴儿出生，需要NICU住院。 这种新生儿重症监护室的停留，虽然医学上是必要的，但可能会导致发育中的婴儿大脑受损。在 特别是，缺乏对婴儿指导的父母或看护人的声音的接触。众所周知， 婴儿的定向言语，这是不同于成人的定向言语，是发展的重要， 最佳的早期大脑发育区分语音的能力是发展的先决条件 更复杂的接受性语言。婴儿定向言语，理想情况下是由专注的婴儿寻求， 刺激大脑神经，使婴儿的大脑适应语音。对于发育中的婴儿大脑来说， 语言学习的“可塑性”在婴儿期达到顶峰，因为婴儿的神经连接发展， 区分他们母语的语音。这些连接是更复杂的 大脑功能部分由于在NICU护理中的时间，早产儿的接受语言得分较差 两岁的时候大多数人在学龄前需要言语和语言干预。目前没有 针对NICU引起的言语声音区分不良问题的干预 住院期间是改善结果的最大潜力时期。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 生产一小批器械，以支持在Emory进行的拟议随机临床研究 研究结果将提交给FDA，以批准该创新器械上市。