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

• 批准号: 10459804
• 负责人: Nathalie Maitre
• 金额: $ 27.18万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10459804
• 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

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.

项目总结/摘要 每年，美国有50万婴儿早产，全世界有1500万婴儿早产。几乎所有早产儿 婴儿患有由大脑不成熟和脑发育障碍之间的相互作用引起的异常大脑成熟。 非典型早期子宫外经验。出院回家后，他们对感觉神经元的反应性 在家里的经历，与儿童时期更糟糕的发展结果有关。改善这些 结果，在新生儿期进行干预至关重要，因为此时可塑性和级联效应最大 潜力需要设计严格、标准化和基于机械的多传感器 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， 新生儿期，对家中的感觉反应以及更好的语言和运动产生下游影响 儿童早期的结果。因此，该提案的总体目标是验证一种安全的、二分的- 中心治疗构建容易获得的技术和父母衍生的刺激，适应广泛的 新生儿环境的多样性。 为了实现这一点，我们提出了一个随机对照试验与意向治疗分析，在200住院 月经后32 - 36周的早产儿。多感官干预，包括 12次标准化的治疗师管理的触觉刺激，并结合特遣队 记录了母亲的声音，使用奶嘴激活系统，在支持性触觉的情况下 在治疗师的胸口上我们的方法结合了一个易于使用的FDA批准的奶嘴- 当婴儿吮吸奶嘴时，播放父母声音的激活装置。控制舱 近似于一种护理方法，可以改善肌肉功能，婴儿神经调节，父母-婴儿 联系和深度睡眠干预组在监测标准的基础上加用治疗 在乎对照组将仅接受监测的护理标准（即，父母和日常的皮肤护理 家长的录音曝光）。多感觉和单感觉神经处理将在 进入研究和治疗期后，使用新型事件相关电位（ERP）评估， 它们是快速和非侵入性的，既不需要积极参与，也不需要直接关注。感觉反应性 将在1年内进行测量。语言和运动结果将在2年时进行测试。 这项提议的短期目标是直接测试多感觉治疗影响 通过对多感觉处理的影响来影响神经发育结果。我们还将获得定量 以及有关群体对治疗反应的机械相关信息，以帮助优化未来的干预措施 设计并在父母无法持续在场的多个新生儿护理环境中实施 在孩子的床边