Sensorimotor Control of the Human Orofacial System

描述（由申请人提供）：一种新的合成模式皮肤刺激技术（NTrainer）先前已被证明可以在人类婴儿中携带吮吸中枢模式发生器（sCPG）。NTrainer的有效性将在四组早产儿的随机试验中进行测试。所选的三个临床人群尤其有明显的运动功能障碍和喂养困难的风险，包括：(1)中度至重度呼吸窘迫综合征（RDS）病史的婴儿，(2)慢性肺部疾病和/或支气管肺发育不良（CLD/BPD）的婴儿，以及(3)唐氏综合征（DS）的婴儿。出生胎龄在26 - 32周的早产儿将被随机分配到实验组（使用NTrainer治疗）和对照组（不使用假刺激治疗）亚组。第四组将由健康的早产儿组成。据推测，具有显著RDS、CLD/BPD和唐氏综合征病史的早产儿在NTrainer治疗后会表现出显著的sCPG重组和激活。主要结局变量包括每日非营养性吸吮动态测量（NeoSuck）、非营养性吸吮时空指数（STI NNS）、无节律运动行为、NNS周期分析、早期喂养技能评估、从管饲到口饲的过渡时间、喂养效率和住院时间。第二个主要目标将包括对3岁时神经发育结果的全面评估。Bayley III发展量表和一系列标准化的发音、词汇、语法和语言探针将提供关于生产和接收的重要信息。这些措施将评估早产儿运动状态、NTrainer刺激效果和神经发育结果之间的潜在联系。早产是儿童发育障碍的主要原因，包括脑瘫、智力迟钝、失明、慢性肺部问题、注意力缺陷和言语/语言障碍。喂养能力是许多早产儿面临的另一个具有挑战性的障碍，特别是对于那些有与呼吸系统疾病、神经损伤或某些损害运动发育的遗传缺陷相关的广泛氧气史的早产儿。漫长的插管过程使婴儿在大脑发育的关键时期失去了宝贵的感觉和运动经验。使用一种新颖的方法来加速口腔运动技能的发展，为口腔感觉系统提供有模式的口腔皮肤刺激，将直接有益于日益增长的脆弱婴儿群体，从而提高吮吸技能，缩短从喂食管到口服喂养的过渡时间，缩短住院时间，并促进更积极的神经发育结果。公共卫生相关性：早产在美国正以惊人的速度上升，与八分之一的活产有关。早产发生在大脑发育的关键时期，是儿童发育障碍的主要原因，包括脑瘫、智力迟钝、失明、慢性肺部问题、注意力缺陷和言语/语言障碍。喂养能力是许多患有呼吸系统疾病、脑损伤或某些影响口腔发育的遗传缺陷的早产儿面临的另一个挑战。一种名为NTrainer的新型医疗设备将在一项随机试验中对240名插管喂养的早产儿进行测试，以确定一种新型合成口腔刺激疗法是否能有效地加速吮吸和喂养技能的发展，促进大脑发育，缩短住院时间，并改善3岁时的语言和运动技能。

DESCRIPTION (provided by applicant): A new synthetic patterned orocutaneous stimulation technique (NTrainer) has been shown previously to entrain the suck central pattern generator (sCPG) in human infants. The effectiveness of the NTrainer will be tested in a randomized trial among four groups of preterm infants. Three of the clinical populations selected are especially at risk for significant oromotor dysfunction and feeding difficulties, including babies with (1) moderate-severe history of respiratory distress syndrome (RDS), (2) chronic lung disease and/or bronchopulmonary dysplasia (CLD/BPD), and (3) infants with Down syndrome (DS). Preterm infants distributed among these groups with birth gestational ages between 26 and 32 weeks will be randomly assigned to experimental (Treatment w/NTrainer) and control (No Treatment sham stimulation) subgroups. The fourth group will consist of HEALTHY preterm infants. It is hypothesized that premature infants with a significant history of RDS, CLD/BPD, and Down syndrome will demonstrate significant reorganization and activation of the sCPG following NTrainer treatment. Primary outcome variables include daily measures of non-nutritive suck dynamics (NeoSuck), spatiotemporal index of the non-nutritive suck (STI NNS), ororhythmic motor behavior, NNS cycle period analysis, early feeding skills assessment, transition time from tube-to-oral feed, feeding efficiency, and length of hospital stay. A second major objective will include a comprehensive assessment of neurodevelopmental outcome at 3 years of age. The Bayley III Developmental Scales and a battery of standardized articulation, vocabulary, grammar, and speech-language probes will provide vital information on production and reception. These measures will assess the potential link between oromotor status in prematurity, effects of NTrainer stimulation, and neurodevelopmental outcome. Prematurity is the leading cause of developmental disabilities in children, including cerebral palsy, mental retardation, blindness, chronic lung problems, attention deficit, and speech/language disorders. Feeding competency is another challenging hurdle facing many premature babies, especially for those who have an extensive oxygen history associated with respiratory disease, neurologic insult, or certain genetic defects which impair oromotor development. The lengthy intubation procedures cost the baby precious sensory and motor experiences during a critical period of brain development for oromotor pattern generation. Accelerated development of oromotor skills using a novel method for delivering patterned orocutaneous stimulation to the oral sensorium will directly benefit this growing population of fragile infants, leading to enhanced suck skills, decreased transition time from gavage tube-to-oral feed, decreased length of hospitalization, and promote a more positive neurodevelopmental outcome. PUBLIC HEALTH RELEVANCE: Prematurity is rising at an alarming rate in the United States, associated with 1 in 8 live births. Prematurity occurs during a critical period of brain development and is the leading cause of developmental disabilities in children, including cerebral palsy, mental retardation, blindness, chronic lung problems, attention deficit, and speech/language disorders. Feeding competency is another challenging hurdle facing many premature babies who have respiratory disease, brain injury, or certain genetic defects which impair oral development. A new medical device known as the NTrainer will be tested in a randomized trial among 240 tube-fed premature infants in order to determine if a novel synthetic oral stimulation therapy can effectively accelerate development of suck and feeding skills, enhance brain development, decrease the length of hospitalization, and improve speech-language and motor skills measured at 3 years of age.