RCT to improve multisensory neural processing, language & motor outcomes in preterm infants

改善多感觉神经处理、语言的随机对照试验

基本信息

批准号：
10480084
负责人：
Nathalie Maitre
金额：
$ 25.18万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10480084
关键词：
1 year old 2 year old Acoustic Stimulation Address Affect Aftercare Age Auditory Birth Brain Caring Chest Child Child Rearing Childhood Containment Development Devices Early Intervention Environment Event-Related Potentials Exposure to FDA approved Family Future Goals Home Hospitalization Impairment Infant Intervention Language Learning Light Masks Measurable Measures Mediating Methods Monitor Mothers Motor Muscle function Neonatal Neonatal Intensive Care Units Neurologic Outcome Pacifiers Parents Pattern Performance Phase Play Premature Infant Randomized Controlled Trials Reaction Reporting Resources Role School-Age Population Sensory Sensory Deprivation Skin Skin Care Sleep Speech Speech Sound Standardization Stimulus Structure Support System System Tactile Technology Testing Time Toddler Touch sensation Uterus Variant Voice Work base brain abnormalities critical period design directed attention early childhood experience group intervention improved improved outcome infant outcome intervention effect language outcome multisensory neonatal care neonatal period neuroregulation novel peer post intervention psychologic public health relevance relating to nervous system response routine care sensory stimulus sensory system socioeconomics standard care standard of care sucking tactile stimulation therapy design treatment response trial design

项目摘要

PROJECT SUMMARY/ABSTRACT Every year, ½ million infants are born prematurely in the US and 15 million worldwide. Almost all preterm infants suffer from abnormal brain maturation resulting from interactions between brain immaturity and an atypical early extra uterine experience. At discharge to home they often have altered reactivity to sensory experiences in the home, associated with worse developmental outcomes in childhood. To improve these outcomes, it is critical to intervene in neonatal period when plasticity and cascading effects have the greatest potential. The need exists to design rigorous, standardized and mechanistically-based multisensory interventions leveraging parent support, in order to improve measurable multisensory neural processing in the neonatal period, with downstream effects on sensory reactivity in the home and better language and motor outcomes in early childhood. The overarching goals of this proposal are therefore to validate a safe, dyad- centered therapy constructed with easily available technology and parent-derived stimuli, adaptable to a wide variety of neonatal environments. To accomplish this, we propose a randomized controlled trial with intent-to-treat analysis in 200 hospitalized preterm infants between 32 and 36 weeks' post-menstrual age. The multisensory intervention, which includes 12 sessions of standardized, therapist-administered, auditory-tactile stimulation, and combines contingent recorded mother's voice delivered using a pacifier-activated system during holding with supportive tactile containment against the therapist's chest. Our approach incorporates an easy-to-use FDA approved pacifier- activated device to play parents' voice in response to infant suck on a pacifier. The containment hold approximates a care approach shown to improve muscle function, infant neuroregulation, parent-infant bonding, and deep sleep. The intervention group will receive the treatment in addition to monitored standard care. The contrast group will receive only monitored standard of care (i.e., skin-to-skin care by parent and daily sessions of parent's voice recording exposure). Multi- and uni- sensory neural processing will be measured at entry into the study and after the treatment phase, using novel event-related potential (ERP) assessments, as they are rapid and non-invasive, requiring neither active participation nor directed attention. Sensory reactivity will be measured at 1 year. Language and motor outcomes will be tested at 2 years. The short-term objective of this proposal is to directly test the hypothesis that multisensory treatment affects neuro-developmental outcomes through its effect on multisensory processing. We will also obtain quantitative and mechanistically relevant information on group response to treatment to help optimize future intervention designs and implement them in multiple neonatal care settings where parents cannot continuously be present at their child's bedside.

项目摘要/摘要每年，½万名婴儿在美国和全球1500万。几乎所有早产婴儿因脑不成熟与A的相互作用而导致的脑部成熟异常到家中，它们通常会改变对感觉的反应性家中的经验，与童年时期的发展成果较差有关。改善这些结果，当可塑性和级联效应最大时，干预新生儿时期至关重要潜在的。存在设计严格，标准化和机械多感官的需求利用父母支持的干预措施，以改善可测量的多感觉神经处理新生儿时期，对家庭的感觉反应性以及更好的语言和电动机的下游影响童年的结果。因此，该提案的总体目标是验证一个安全的，二元 - 以易于获得的技术和父母衍生的刺激构建的中心疗法，可适应广泛各种新生儿环境。为此，我们提出了一项随机对照试验，并在200个住院月经后32至36周之间的早产婴儿。多感官干预，其中包括 12个标准化的治疗师管理，听觉刺激的会议，并结合了应有的录制的母亲的声音在保持触觉期间使用奶嘴激活的系统传递抵御治疗师的胸部。我们的方法结合了易于使用的FDA批准的奶嘴 - 激活的设备以播放父母的声音，以响应婴儿在奶嘴上吮吸。遏制保留近似一种护理方法，以改善肌肉功能，婴儿神经调节，父母侵害结合和深度睡眠。干预组除了监视标准外还将获得治疗关心。对比组将仅获得受监控的护理标准（即，由父母和每天的皮肤护理和皮肤护理父母语音记录的会议）。将测量多种感觉神经处理进入研究和治疗阶段之后，使用新型事件相关电位（ERP）评估，它们是快速且无创的，既不需要积极参与也不需要注意。感觉反应性将在1年内测量。语言和运动结果将在2年后进行测试。该提案的短期目标是直接检验多感官治疗会影响的假设神经发展结果通过其对多感觉处理的影响。我们还将获得定量以及有关小组对治疗反应的机械相关信息，以帮助优化未来的干预在多个新生儿护理环境中设计并实施它们，在这些环境中，父母不能继续存在在他们孩子的床边。