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:
- 金额:$ 119.15万
- 依托单位:
- 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:
- 关键词:2 year oldActive LearningAddressAdultAffectAgeAuditoryAuditory PerceptionAuditory systemBehavior assessmentBirthBrainCalibrationCaregiversCaringChildClinicalClinical ResearchClinical TrialsCognitionCognitiveComplexDataDevelopmentDevelopmental Delay DisordersDevicesEconomicsElectroencephalographyEnsureEnvironmentExposure toFamilyFoundationsFundingGeographyHearingHospitalizationHospitalsHumanImpairmentIncubatorsInfantInfection ControlInterventionJusticeLanguageLanguage DelaysLanguage DevelopmentLearningLoudnessMarketingMeasurementMeasuresMothersNeonatal Intensive Care UnitsNewborn InfantNoiseNursesOutcomeOutcome MeasurePacifiersParentsPatternPhasePhysiologicalPoliciesPopulationPregnancyPremature BirthPremature InfantProcessProtocols documentationRandomizedRandomized, Controlled TrialsReadingRecommendationResearchSafetyScheduleSchool-Age PopulationSpeechSpeech SoundStimulusStructureSystemTeam NursingTechnologyTestingTherapeuticTimeUnited StatesUniversitiesUterusVoiceauditory processingauditory stimulusawakebrain basedclinical practicecognitive developmentdesignearly childhoodeffective interventionempowermentexperiencefamily supporthealth determinantshigh riskimprovedimproved outcomeinfancyinfection riskinnovationintervention effectlanguage outcomelanguage processingmanufacturemedically necessary careneuralneural circuitneurosensorypeerprematurepressureproduct developmentprototypepsychologicresearch and developmentresponsesensorsocialsocial health determinantssoundstandard caresuckingtargeted treatmentverbal
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
项目成果
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