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: 9767235
• 负责人: Nathalie Maitre
• 金额: $ 43.72万
• 依托单位: RESEARCH INST NATIONWIDE CHILDREN'S HOSP
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-20 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9767235
• 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 environment; 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; 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.

项目概要/摘要 每年，美国有 500 万婴儿早产，全球有 1500 万婴儿早产。几乎都是早产 婴儿的大脑发育异常，是由于大脑不成熟和大脑发育不成熟之间的相互作用造成的。 非典型的早期子宫外经历。出院回家时，他们通常会改变对感官的反应 家庭经历与童年时期较差的发育结果有关。为了改善这些 就结果而言，在可塑性和级联效应最大的新生儿期进行干预至关重要 潜在的。需要设计严格、标准化和基于机械的多感官 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，对家庭中的感觉反应性以及更好的语言和运动产生下游影响 幼儿期的结果。因此，该提案的总体目标是验证一个安全的、二元的 以易于获得的技术和来自父母的刺激构建的以中心为中心的治疗，适用于广泛的 各种新生儿环境。 为了实现这一目标，我们提出了一项随机对照试验，对 200 名住院患者进行意向治疗分析 月经后 32 至 36 周的早产儿。多感官干预包括 12 次标准化、治疗师管理的听觉触觉刺激课程，并结合了偶然性 记录母亲在抱抱期间使用安抚奶嘴激活系统发出的声音，并提供支持性触觉 遏制治疗师的胸部。我们的方法采用了 FDA 批准的易于使用的奶嘴 - 激活装置播放父母的声音以响应婴儿吮吸奶嘴的声音。收容措施 近似一种可改善肌肉功能、婴儿神经调节、亲子关系的护理方法 亲密关系和深度睡眠。干预组将接受除监测标准外的治疗 关心。对照组将仅接受受监控的标准护理（即父母的皮肤接触护理和日常护理） 家长录音曝光的会话）。多感觉和单感觉神经处理将在 进入研究和治疗阶段后，使用新颖的事件相关电位（ERP）评估，如 它们是快速且非侵入性的，既不需要积极参与，也不需要直接关注。感觉反应 将在1年进行测量。语言和运动结果将在 2 岁时进行测试。 该提案的短期目标是直接检验多感官治疗影响的假设 通过对多感觉处理的影响来影响神经发育结果。我们还将获得定量的 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 在父母无法持续在场的多个新生儿护理环境中设计并实施它们 在他们孩子的床边。