Preterm Infants: Light Effects on Health and Development

描述（由申请人提供）：即使是最健康的早产儿，其健康和发育结果也各不相同。这些结果的差异导致推测新生儿重症监护病房的环境，特别是光线，可能会影响结果。最近，循环光照显示出对接近黑暗的婴儿的短期益处，但尚不清楚应该在什么胎龄开始循环光照，以及这些益处是否会长期持续。一些证据表明，在孕28周时，视觉感觉系统已经能够处理光刺激，因为大脑的神经元已经完全补充，迁移和分化已经开始，视交叉上核受到视网膜的神经支配，对光有反应。该研究评估了早周期光照和晚周期光照在住院期间对小于28周出生婴儿的短期和长期健康和发育结局的影响。采用纵向随机实验设计，140名婴儿将被分配到：(1)早期循环光照（受孕后28周[PCA]）或(2)晚期循环光照（36周PCA）。在整个住院期间对婴儿进行随访，以评估体重增加、住院天数、睡眠-觉醒状态发展、早产儿视网膜病变和听觉灵敏度的短期结果。婴儿出院后将被随访至24个月矫正年龄，以评估体重增加、睡眠模式、视力、发育（认知、运动、语言）和神经系统结果。数据是连续变量和分类变量的混合物，将使用混合一般线性模型、广义估计方程、多元方差分析和卡方分析进行分析。早产儿接受早期循环光治疗，预期会有更好的结果，因为他们会在可以利用的时候接受循环光治疗。虽然全国大多数新生儿重症监护室以某种方式改变了光环境，但没有一个国家标准的环境光护理，因此确定什么时候循环光或接近黑暗是最合适的是很重要的。

DESCRIPTION (provided by applicant): Health and developmental outcomes vary even among the healthiest preterm infants. These variations in outcome have led to speculation that the neonatal intensive care unit environment, and light in particular, may impact outcomes. Recently, cycled light has shown short-term benefits over near darkness, but it is unclear at what gestational age cycled light should be initiated and whether these benefits continue long term. Some evidence suggests that at 28-weeks gestational age the visual sensory system is capable of handling light stimulation since the brain has a full complement of neurons, migration and differentiation is beginning, and the suprachiasmatic nuclei is innervated by the retina and responsive to light. The proposed study evaluates the timing and effects of early versus late cycled light throughout hospitalization on short-and long-term health and developmental outcomes in infants born at < 28 weeks gestation. Utilizing a longitudinal randomized experimental design, 140 infants will be assigned to either: (1) early cycled light (28 weeks post-conceptional age [PCA]) or (2) late cycled light (36 weeks PCA). Infants will be followed throughout hospitalization to evaluate the short-term outcomes of weight gain, number hospital days, sleep-wake state development, retinopathy of prematurity, and auditory acuity. Infants will be followed after discharge until 24 months corrected age to evaluate weight gain, sleep patterns, visual acuity, development (cognitive, motor, language) and neurological outcomes. Data, a mixture of continuous and categorical variables, will be analyzed using mixed general linear models, generalized estimating equations, multiple analysis of variance, and chi-square. Preterm infants receiving early cycled-light are expected to have better outcomes because they will receive cycled light when it can be utilized. While most NICUs across the country modify the light environment in some fashion, a national standard of care for environmental light does not exist, therefore it is important to determine when cycled light or near darkness is most appropriate.