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

项目摘要/摘要 每年，美国有50万名早产婴儿，全球有1500万名。几乎所有的早产 婴儿大脑发育不成熟和脑功能不全相互作用导致的大脑发育异常 非典型的早期宫外症。在出院回家时，它们经常改变对感官的反应性 在家中的经历，与儿童时期较差的发展结果有关。要改善这些 结果，在可塑性和级联效应最大的新生儿期进行干预至关重要 潜力。需要设计严格的、标准化的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官神经加工 新生儿期，对家庭的感觉反应性和更好的语言和运动产生下游影响 儿童早期的结果。因此，这项提案的首要目标是验证一个安全的、二元的- 以易于获得的技术和父母衍生的刺激构建的中心疗法，适用于广泛的 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、听觉-触觉刺激，并结合应急 在支持触觉的抱抱过程中，使用奶嘴激活系统发出的录音母亲的声音 控制住治疗师的胸腔。我们的方法结合了FDA批准的易于使用的奶嘴- 当婴儿吮吸奶嘴时，激活的设备可以播放父母的声音。围堵货舱 接近改善肌肉功能、婴儿神经调节、亲子关系的护理方法 亲密无间，沉沉的睡眠。干预组在监测标准的基础上进行治疗 关心。对照组将只接受受监测的标准护理(即由父母和每天进行皮肤到皮肤的护理 家长的录音暴露的会话)。多感官和单感官神经处理将在 进入研究阶段和治疗阶段后，使用新的事件相关电位(ERP)评估，如 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 将按1年计算。语言和运动成绩将在两年后进行测试。 这项提议的短期目标是直接检验多感官治疗影响 通过其对多感觉加工的影响而导致的神经发育结果。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 在父母不能持续在场的多个新生儿护理环境中设计和实施 在他们孩子的床边。

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.