Preterm Fetal Growth Restriction and Developmental Care

早产胎儿生长受限和发育护理

• 批准号: 6915736
• 负责人: HEIDELISE ALS
• 金额: $ 47.87万
• 依托单位: BOSTON CHILDREN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6915736
• 关键词: brain; clinical research; developmental neurobiology; electroencephalography; embryo /fetus; gestational age; growth /development; human subject; neurophysiology; premature infant human; prenatal growth disorder; prenatal stress

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.

描述（由申请人提供）：胎儿生长受限（FGR）增加了早产对婴儿生存、整体功能和后期学习能力的重大风险。在美国每年12%的早产儿中，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室（NICU）提出了直接的重大挑战;超过70%的婴儿将发展为学习障碍，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婴儿的低阈值的反应和危害已经受损的大脑发育。拟议的项目将测试新生儿重症监护室干预对这些婴儿的有效性。它将包括努力使所有护理个体化，以适应婴儿的敏感阈值，从而改善神经纤维束发育（MRI）和神经生理功能（EEG）。这反过来又会导致更好的行为适应。将30名FGR早产儿随机分配至发育护理（E）组或标准护理（C）组。所有婴儿将在出生后7天内（基线）进行研究，并在2周龄（2周CA）时再次进行研究（结局）。预计FGR-E组在2周CA时在待测试的3个领域（神经行为、电生理学和脑结构）中显示出更好的发育。此外，将FGR婴儿与适合胎龄生长（阿加）的早产婴儿样本进行比较，这些早产婴儿在先前研究的两个年龄点都有可比数据。将比较FGR和阿加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措施与样本特定风险因素的相互作用。将在各自领域的背景变量、干预和结果之间检查关系和预测成功。将采用按领域的重复测量多变量方差分析来评估样本、组和时间效应及其相互作用。将采用判别函数分析、典型相关、多元回归和路径分析，以建立领域和跨年龄关系的模型，并预测干预效果。预期结果将显示干预对FGR婴儿的基于大脑的影响，通过减轻压力来介导。这有望使他们在功能和大脑结构发育方面与阿加同龄人更接近。这项研究对于了解如何减少FGR婴儿的长期功能性发病率以及确定增强最后三个月大脑发育的机会具有重要意义。