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

基本信息

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
项目类别：
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

项目摘要

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.

项目描述蓬勃发展的神经医学有限责任公司的提议，以开发，测试和获得FDA清除以销售治疗设备改善新生儿重症监护病房住院的早产儿的语音分化（NICU）。在此项目中，我们将完成SmallTalk NICU活动系统的开发，并进行临床试验以证明其在改善住院早产儿的语音差异方面的有效性。该设备设计为在妊娠32周的年龄上使用并整合很容易地进入临床实践，供护士和治疗师配备II级的IV级NICUS。原型研发达到或超过了既定的技术里程碑。在2020年，早产影响1 在美国出生的10名婴儿中。大量婴儿每天出生，需要NICU住宿。这种NICU停留虽然在医学上必不可少，但可能会导致发育中的婴儿大脑受损。在特别是，缺乏接触婴儿的父母或看守的声音。众所周知对于婴儿的指示语音，这与成人定向语音不同，对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。婴儿指导语音，理想情况下，当一个专心的婴儿寻求时，刺激大脑接线，并使婴儿的大脑发出语音。对于发育中的婴儿大脑，婴儿期间语言学习的“可塑性”，因为婴儿的开发神经连接启用了区分他们的母语的讲话。这些连接是更复杂的基础大脑功能。在某种程度上是由于他们在NICU护理中的时间，早产儿的接受语言得分较差在二岁时。多数需要在学龄前年龄之前的语音和语言干预。目前没有解决了NICU引起的语音差异问题的干预措施住院，这是改善结果的最大潜力的时期。该建议寻求用于最终产品开发和SmallTalk NICU活动系统的严格测试的资金。我们将生产一小部分设备，以支持Emory提议的随机临床研究大学，其结果将提交给FDA以进行清关，以销售创新设备。