Preterm Fetal Growth Restriction and Developmental Care

描述（由申请人提供）：胎儿生长受限（FGR）增加了已经存在的早产儿的生存、整体功能和后期学习能力的风险。在美国每年12%的早产婴儿中，超过5%的婴儿由于胎盘功能不全而无法在子宫内正常生长。这些婴儿对新生儿重症监护病房（NICU）提出了紧迫的重大挑战；超过70%的人会发展为学习障碍，需要特殊的教育服务。据推测，新生儿重症监护室的压力环境可能会加剧FGR婴儿的低反应阈值，并危及已经受损的大脑发育。拟议的项目将测试在新生儿重症监护病房对这些婴儿进行干预的有效性。它将包括针对婴儿敏感阈值的个性化护理，从而改善神经纤维束发育（MRI）和神经生理功能（EEG）。这反过来又有望导致更好的行为适应。30名FGR早产儿将被随机分为发育护理组(E)或标准护理组(C)。所有婴儿将在出生后7天内（基线）和校正后2周（2w CA）（结果）再次进行研究。FGR-E组预计在2w CA时在待测的三个领域（神经行为、电生理和大脑结构）中表现出更好的发展。此外，FGR婴儿将与胎龄（AGA）早产儿生长适宜的样本进行比较，后者可从先前的研究中获得两个年龄点的可比数据。将比较FGR和AGA C和E组，以确定干预效果的样本特定方面。这可能会导致更好地理解干预与样本特定风险因素的相互作用。关系和预测成功将在背景变量，干预和各自领域的结果之间进行检查。将采用重复测量多变量方差分析来评估样本、群体和时间效应及其相互作用。判别函数分析、典型相关、多元回归和路径分析将被用于建模领域和跨年龄的关系，并预测干预的有效性。结果预计将显示干预对FGR婴儿的基于大脑的影响，介导压力减轻。预计这将使他们在功能和大脑结构发展方面更接近AGA的同龄人。这项研究对于了解如何减少FGR婴儿的长期功能发病率，以及确定促进晚期大脑发育的机会具有重要意义。

DESCRIPTION (provided by applicant): Fetal growth restriction (FGR) increases the already substantial risk of prematurity for infants' survival, overall function and later learning competence. Of the 12% of prematurely born infants in the US each year, more than 5% failed to grow appropriately in the womb due to placental insufficiency. These infants present immediate significant challenges to Newborn Intensive Care Units (NICU); more than 70% will go on to develop learning disabilities and require special educational services. It is postulated that the NICU's stressful environment may exacerbate the FGR infant's low threshold of reactivity and jeopardize already compromised brain development. The proposed project will test the effectiveness of an in-NICU intervention for such infants. It will consist of efforts to individualize all care to the infant's thresholds of sensitivity and to thereby improve neural fiber tract development (MRI) and neurophysiologic functioning (EEG). This in turn is expected to result in better behavioral adaptations. Thirty FGR preterm infants will be randomized to either a Developmental Care (E) or Standard Care (C) group. All infants will be studied within 7 days of birth (baseline) and again at 2 weeks corrected age (2w CA) (outcome). The FGR-E group is expected to show better development at 2w CA in the 3 domains to be tested, neurobehavior, electrophysiology, and brain structure. Furthermore, the FGR infants will be compared to a sample of appropriate in growth for gestational age (AGA) preterm infants for whom comparable data are available at both age points from a previous study. The FGR and AGA C and E groups will be compared in order to identify sample specific aspects of the intervention effects. This might lead to better understanding of the intervention's interaction with sample specific risk factors. The relationship and predictive success will be examined among background variables, intervention, and outcomes in the respective domains. Repeated measures multivariate analysis of variance by domain will be employed to assess sample, group and time effects as well as their interactions. Discriminate function analysis, canonical correlation, multiple regression as well as path analysis will be employed in order to model domain and across age relationships, and to predict intervention effectiveness. Results are expected to show brain-based effects of the intervention for the FGR infants, mediated by stress reduction. This is expected to bring them closer in functioning and brain structural development to their AGA peers. The study will be significant in understanding ways to reduce long-term functional morbidities in FGR infants, as well as in identifying opportunities for enhancing last trimester brain development.