NEO rehab program for premature infants at risk for cerebral palsy

针对有脑瘫风险的早产儿的 NEO 康复计划

• 批准号: 9906927
• 负责人: Lisa Letzkus
• 金额: $ 16.15万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-04 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9906927
• 关键词: Activities of Daily Living; Address; Adherence; Age; Algorithms; Assessment tool; Birth; Brain; Brain Injuries; Caring; Cerebral Palsy; Child; Chronic; Cranial Nerves; Data; Development; Diagnosis; Disease; Early Intervention; Early identification; Economic Burden; Emotional; Enrollment; Evidence based intervention; Family; Gestational Age; Goals; Hospitalization; Infant; Injury; Intervention; Interview; Kangaroo-Mother Care; Knowledge; Live Birth; Longevity; Massage; Measures; Medical; Medical center; Mothers; Motor; Movement; Movement Disorders; Muscle Cramp; Neonatal Intensive Care Units; Neurologic Examination; Outcome; Parents; Participant; Performance; Physical therapy; Posture; Pregnancy; Premature Infant; Prevalence; Prevention; Randomized; Randomized Controlled Trials; Reflex action; Rehabilitation therapy; Reproducibility; Research; Research Personnel; Research Priority; Research Project Grants; Risk; Screening procedure; Sensorimotor functions; Services; Severities; Special Education; Supportive care; Testing; Time; Touch sensation; Walking; base; care systems; control trial; design; disability; early childhood; efficacy testing; environmental enrichment for laboratory animals; follow-up; high risk; improved; infant outcome; innovation; instrument; life time cost; multi-component intervention; multimodality; neuromuscular; novel; premature; primary outcome; programs; recruit; rehabilitation research; standard of care; synaptic pruning; therapy development; tool; treatment as usual; trial comparing; trial design

Abstract Cerebral Palsy (CP) is the most common motor disability in children born preterm. CP can cause profound disability, lifelong need for extensive care and result in significant economic burden. Ideally infants at risk for CP should be identified while still in the neonatal intensive care unit (NICU), at a stage of rapid brain development where intervention may have an impact on synaptic pruning and brain rewiring. The general movement assessment (GMA) tool has been shown to reliably identify infants at high risk for CP and can be implemented shortly after birth making it an ideal screening tool for preterm infants. This tool provides a unique opportunity to greatly decrease the age of CP diagnosis, an essential step for the implementation of earlier, potentially course-modifying interventions. Previous studies indicate that intervention focusing on environmental enrichment, emotional connection between mother and infant can positively impact the neurodevelopmental outcomes of infants born preterm. However, whether this type of interventions can improve the motor outcomes of infants at risk for CP remains unknown. To address this gap in knowledge, we have developed a NICU-based multimodal rehabilitation program (NEO rehab) to support neuromuscular development in preterm infants at high risk for CP (as determined by the GMA). This multimodal program, is composed of 6 evidence-based interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy) administered in a GA appropriate fashion by a parent. We hypothesize that this innovative NEO rehab program will positively impact short-term motor outcomes in preterm infants at risk for CP. At risk infants (≤32 week’s gestation and/or ≤1500 grams birthweight) will be eligible for a pilot randomized controlled trial (RCT) comparing the effects of the NEO rehab program versus usual care on short term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes). The effects of the NEO rehab program the primary outcome will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments at NICU discharge and at 3 months corrected GA. In addition, the acceptability, feasibility and fidelity of the Neo Rehab program will be determined by performing direct observation, weekly interviews and activity log reviews. This study addresses one of the priorities of the National Center for Medical Rehabilitation Research to explore “multimodal rehabilitation approaches that promote plasticity and sensorimotor function”. Results from this study will provide the preliminary evidence necessary to design and implement a large, multi-center RCT to test the efficacy of NICU-based rehabilitation programs to improve the motor outcomes of infants born preterm.

抽象的 脑瘫（CP）是出生早产儿童中最常见的运动障碍。 CP可能会导致深刻 残疾，终身需要进行广泛的护理，并带来巨大的经济负担。理想情况是有风险 在新生儿重症监护病房（NICU）时，应在大脑快速的阶段确定CP 干预可能会影响突触修剪和大脑重新布线的开发。将军 运动评估（GMA）工具已被证明可靠地识别出CP高风险的婴儿，并且可以是 出生后不久就实施了它是早产儿的理想筛查工具。该工具提供了独特的 大大降低CP诊断年龄的机会，这是实施早期的重要步骤， 潜在的课程修改干预措施。先前的研究表明，重点关注的干预措施 环境丰富，母亲和婴儿之间的情感联系会对 婴儿早产婴儿的神经发育结果。但是，这种干预措施是否可以 改善有CP风险的婴儿的运动结果仍然未知。为了解决知识中的这一差距，我们 已经开发了基于NICU的多模式康复计划（NEO REHAB）来支持神经肌肉 CP高风险的早产儿（由GMA确定）的发育。这个多模式的程序是 由6种基于证据的干预措施（声音舒缓，疤痕交换，舒适触摸，袋鼠组成 护理，婴儿按摩和物理疗法）由父母以适当的方式给药。我们 假设这项创新的NEO REAB计划将对短期运动结果产生积极影响 早产婴儿有CP的风险。处于风险的婴儿（≤32周的妊娠和/或≤1500克出生体重）将是 有资格进行试验随机对照试验（RCT），比较NEO REHAB计划的影响与 短期运动结果（通用运动（GM），颅神经，姿势，运动， 音调和反射）。新修复计划的影响将使用 GMA，婴儿运动性能（TIMP）和锤子婴儿神经系统检查的测试 （Hine）NICU排放和3个月后的仪器进行了校正。另外，可接受性，可行性 Neo Rehab计划的保真度将通过进行直接观察，每周访谈来确定 和活动日志评论。这项研究涉及国家医疗中心的优先事项之一 康复研究以探索“促进可塑性和的多模式康复方法 感觉运动功能”。这项研究的结果将提供设计和设计所需的初步证据 实施大型多中心RCT，以测试基于NICU的康复计划的效率，以改善 婴儿早产的婴儿的运动结果。