The association between preterm milk immunobiology and infant health

描述(由申请人提供)：拟议的研究将调查乳汁免疫生物学和乳量是否与极早产儿(750到1500克)的肠道健康、皮肤免疫和临床结局有关。在这些脆弱的婴儿面临的多重风险中，母乳可能起到了缓和作用，但早产儿获得的母乳总量极不稳定。在将进行这项研究的新生儿重症监护病房(NICU)，只有40%的婴儿出院时接受了任何母乳，这并不少见。人们对早产母乳的基本成分知之甚少，也不知道是否有一些成分对最理想的婴儿结局至关重要。将招募100名母婴双胞胎，预计至少有75名将继续进行研究，并在NICU停留6周进行研究。在每次喂养时，将从母亲提供的牛奶中提取非常少量的样本，然后将其与配方奶粉和补充剂混合。这些等量数据将被汇集在一起，每周通过一个多重小组进行分析，以确定细胞因子、趋化因子和生长因子。分泌型免疫球蛋白A浓度也将被检测。将准确记录每一次喂奶的体积、母乳的体积以及配方奶粉和强化剂的体积。此外，每周将从尿布上收集粪便样本，进行每周一次的粪便钙保护素分析，这是肠道病理生理学的早期标志。皮肤免疫力将被评估为潜在的免疫能力的生物标记物，方法是将一条小胶带贴在额头上，然后取出一组皮肤免疫成分和细胞因子，并通过多重分析进行检测。其他临床结果将包括口服喂养时间、体重增加、出院时间以及任何重大不良健康后果，如感染或坏死性小肠结肠炎。这将是第一项仔细的研究，将提供NICU住院期间母乳因素和数量的计算，并衡量与婴儿健康、生物标记物和临床结果的关系。它将为我们目前知之甚少的重要关系提供效果大小。 公共卫生相关性：该项目将研究在新生儿重症监护病房住院期间早产儿的母乳免疫和乳量与临床结局、免疫和肠道生物标志物的关系。

DESCRIPTION (provided by applicant): The proposed study will investigate if milk immunobiology and volume are associated with enteral health, skin immunity and clinical outcomes in very preterm infants (750 to 1500 gm). Human milk may play a moderating role in the multiple risks these vulnerable infants face, yet the total volume of human milk preterm infants receive is extremely variable. In the Neonatal Intensive Care Unit (NICU) where the study will be performed, only 40% of infants are discharged receiving any human milk at all, and this is not atypical. Little is known about the essential components of preterm mother's milk and whether there may be some components that are critically involved in the most optimal infant outcomes. One hundred maternal-infant dyads will be recruited, with the expectation that at least 75 will continue through the study, and studied for 6-weeks of their stay in the NICU. At each feeding a very small sample will be aliquoted from the milk mothers provide before it is mixed with formula and supplement. These aliquots will be pooled and analyzed weekly with a multiplex panel for cytokines, chemokines and growth factors. Secretory Immunoglobulin A concentration will also be assayed. Exact recordings of each feeding, in terms of volume, volume of human milk, and volume of formula and fortifiers will be done. In addition, weekly stool samples will be collected from diapers for a weekly analysis of fecal calprotectin, known to be an early marker of enteral pathophysiology. Skin immunity will be assessed as a potential biomarker of immunocompetency through the use of a small tape applied to the forehead, then removed and assayed for a panel of skin immune components and cytokines by multiplex assay. Other clinical outcomes will include time to oral feeding, weight gain, time to discharge, and any significant adverse health outcomes such as infections or necrotizing enterocolitis. This will be the first careful study that will provide a computation of human milk factors and volumes across a NICU stay and a measurement of relationships to infant health, biomarkers and clinical outcomes. It will provide effect sizes for important relationships about which we currently know so little. PUBLIC HEALTH RELEVANCE: This project will study the relationships between human milk immunity and milk volume with clinical outcomes and immune and enteral biomarkers in preterm infants while hospitalized in the neonatal intensive care unit.