Efficacy of Motor and Cognitive Intervention for Infants Born Very Preterm

运动和认知干预对极早产婴儿的功效

基本信息

批准号：
10437697
负责人：
Stacey Chapman Dusing
金额：
$ 43.38万
依托单位：
UNIVERSITY OF SOUTHERN CALIFORNIA
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2024-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10437697
关键词：
3-Dimensional Address Age Age-Months Animals Ataxia Attentional deficit Awareness Basic Science Behavior Behavioral Caring Cerebral Palsy Child Clinical Cognitive Coin Control Groups Cues Development Developmental Delay Disorders Developmental Disabilities Diagnosis Disabled Persons Early Diagnosis Early Intervention Education Enrollment Environment Feasibility Studies Future Guidelines Home Impairment Infant Intervention Intervention Studies Learning Learning Disabilities Life Logistics Measures Mediating Mental Health Motor Motor Skills Movement Musculoskeletal Equilibrium Neonatal Brain Injury Neonatal Intensive Care Units Neuronal Plasticity Outcome Parent-Child Relations Parents Participant Physicians Play Policy Maker Pregnancy Problem Solving Randomized Randomized Clinical Trials Readiness Reading Recommendation Rehabilitation therapy Reporting Research Risk Sampling Service delivery model Services Severities Special Education Therapeutic Intervention Time Toddler Treatment Efficacy United States National Institutes of Health accurate diagnosis base cognitive skill community intervention comparative efficacy disability efficacy evaluation empowered environmental enrichment for laboratory animals evidence base federal policy follow-up group intervention high risk improved improved outcome infant outcome innovation motor learning physical therapist preventive intervention rehabilitation service service intervention skills social systematic review therapy development treatment as usual visual motor

项目摘要

Infants born very preterm (≤28 weeks of gestation) are at high risk of having developmental disabilities including cerebral palsy, coordination impairments, attention deficit and learning disabilities. Impairment including reduced postural control, movement variability, visual motor skills, and motor learning are common during the first months of life and are associated with later developmental disabilities. However, infant born very preterm rarely receive evidence based therapeutic intervention in the first months of life when basic science and animal intervention studies suggest the greatest efficacy. Barriers to enrollment in services delay the onset of services and delivery models rarely support targeted preventative intervention or enhanced parent engagement during in the transition from the neonatal intensive care unit (NICU) to home. Targeted intervention supporting postural control and motor learning in the NICU have resulted in short term motor gains. Interventions that enhance parent's ability to read their infant's cues and provide engagement opportunities improve maternal mental health and infant social and cognitive outcomes in the short-term. The purpose of this randomized clinical trial is to evaluate the efficacy of an intervention that combines evidence based motor intervention and parent engagement to enhance the parent's ability to provide daily motor and cognitive opportunities resulting in improved motor and cognitive outcomes. Supporting Play Exploration and Development Intervention (SPEEDI) uses guided participation to empower parents in reading infant's behavioral cues, identifying ideal times for interaction, and enriching the environment and learning opportunities. Parents participate in 5 session in 3 weeks while learning principles of engagement, readiness for interaction, and to provide early motor and cognitive learning opportunities. Parents provide 20 minutes of motor and cognitive play based enrichment daily for 12 weeks with bi-weekly physical therapist support. The parent is empowered to determine the infant's current abilities and advance the activities to the “Just Right Challenge” throughout the 12 weeks, likely continuing after the intervention. The efficacy of SPEEDI will be assessed in 3 aims: To compare the efficacy of SPEEDI 1) to usual care 2) during delivery at 2 time point; the transition from the NICU to home (around the infant's due date) and beginning at 3-4 months of adjusted age (after the infants due date) 3) for infant who are later diagnosed with Cerebral Palsy and those not Diagnosed with Cerebral Palsy. Ninety infants will be randomly assigned to a Usual Care group, SPEEDI_Early, or SPEEDI_Late group. Group differences will be assessed in developmental outcomes on the motor and cognitive scales of the Bayley Scales for Infant and Toddler Development, Early Problem Solving Indicator, and Gross Motor Function Measure at the end of each intervention period, 12 and 24 months of age. In addition, we will explore a possible mechanism of action, parent's engagement, and the impact of this intervention on the need for later rehabilitation services.

极早产婴儿（妊娠≤28周）出现发育障碍的风险很高包括脑瘫、协调障碍、注意力缺陷和学习障碍。包括姿势控制能力下降、运动变化、视觉运动技能和运动学习都很常见然而，婴儿出生后的最初几个月可能会出现这种情况，并与后来的发育障碍有关。极早产儿很少在生命最初几个月接受基于证据的治疗干预科学和动物干预研究表明，服务登记的最大障碍是延迟。服务的开始和提供模式很少支持有针对性的预防性干预或加强从新生儿重症监护病房 (NICU) 过渡到家庭期间，家长的参与。支持新生儿重症监护病房的姿势控制和运动学习的有针对性的干预措施已导致短期增强父母解读婴儿暗示并提供帮助的能力的干预措施。参与机会可改善母亲的心理健康以及婴儿的社会和认知结果这项随机临床试验的目的是评估干预措施的有效性。结合基于证据的运动干预和家长参与，以增强家长的能力提供日常运动和认知机会，从而改善运动和认知结果。支持游戏探索和发展干预 (SPEEDI) 使用引导参与来帮助父母解读婴儿的行为线索，确定互动的理想时间，并丰富家长在 3 周内参加 5 次课程，同时学习原理。参与、互动准备，并提供早期运动和认知学习机会。家长每天提供 20 分钟的运动和认知游戏，为期 12 周，每两周一次物理治疗师的支持有权确定婴儿当前的能力和进步。为期 12 周的“恰到好处的挑战”活动，可能会在干预后继续进行。 SPEEDI 的功效将通过 3 个目标进行评估：比较 SPEEDI 1) 与常规护理的功效 2) 分娩期间的 2 个时间点；从 NICU 过渡到家中（婴儿预产期前后）以及从调整年龄 3-4 个月开始（婴儿预产期之后）3) 对于后来被诊断患有以下疾病的婴儿脑瘫和未诊断出脑瘫的婴儿将被随机分配到一个组。将在常规护理组、SPEEDI_Early 或 SPEEDI_Late 组中评估组差异。婴幼儿贝利量表运动和认知量表的发育结果发展、早期问题解决指标以及每节结束时的粗大运动功能测量干预期，12个月和24个月龄此外，我们将探索可能的作用机制，家长的参与，以及这种干预对以后康复服务需求的影响。