The association between preterm milk immunobiology and infant health

描述（由申请方提供）：拟定研究将调查乳汁免疫生物学和体积是否与极早产儿（750 - 1500 gm）的肠道健康、皮肤免疫和临床结局相关。人乳可能在这些脆弱婴儿面临的多重风险中发挥调节作用，但早产儿接受的人乳总量变化极大。在将进行研究的新生儿重症监护室（NICU）中，只有40%的婴儿出院后接受任何母乳喂养，这并不典型。关于早产儿母乳的基本成分，以及是否可能有一些成分与最佳婴儿结局密切相关，我们知之甚少。 将招募100对母婴，预计至少75对将继续进行研究，并在NICU中停留6周进行研究。在每次喂养时，将从母亲提供的母乳中等分一个非常小的样本，然后将其与配方奶粉和补充剂混合。将这些等分试样合并，并每周使用细胞因子、趋化因子和生长因子的多重组进行分析。还将测定分泌型免疫球蛋白A浓度。将准确记录每次喂养的体积、人乳体积以及配方奶和强化剂的体积。此外，每周从尿布中采集粪便样本，用于每周分析粪便钙卫蛋白，已知其为肠道病理生理学的早期标志物。皮肤免疫力将作为免疫能力的潜在生物标志物进行评估，方法是将小胶带贴在前额，然后取下，通过多重测定法测定一组皮肤免疫组分和细胞因子。其他临床结局将包括经口喂养时间、体重增加、出院时间和任何重大不良健康结局，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住院期间母乳因子和体积的计算，以及与婴儿健康，生物标志物和临床结果关系的测量。它将为我们目前所知甚少的重要关系提供效应量。

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.