权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

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.

项目总结/文摘