CLINICAL TRIAL: HEALTH IMPACT OF CONGENITAL CYTOMEGALOVIRUS INFECTION

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项提案的总体目标是通过在两年内对来自三家地区医院的20,000名新生儿进行病毒学筛查，确定由人类巨细胞病毒(HCMV)在北加州多样化人口中造成的先天性感染的流行病学和疾病负担。人巨细胞病毒是疱疹病毒家族中的一员。筛查将使用荧光灶直接早期抗原检测(DEAFF)方法来识别新生儿唾液样本中的HCMV。为了评估疾病负担，我们将记录感染婴儿的临床表现，并使用特定的病例定义和分类标准确定有症状和无症状的表现的分布。我们将描述在未来听力筛查计划中登记的受感染婴儿在三年内发生感音神经性听力损失(SNHL)的发生率、严重程度和发病时间，并确定普遍的新生儿听力筛查是否或在多大程度上确定由先天性HCMV感染引起的SNHL。此外，我们还将描述受感染婴儿在生命的前三年中的HCMV特异性CD4和CD8 T细胞反应的发展情况，以评估有症状和无症状感染婴儿之间免疫反应模式的差异。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The overall objective of this proposal is to define the epidemiology and disease burden of congenital infection caused by Human Cytomegalovirus (HCMV), in a diverse, Northern California population by virologically screening 20,000 newborns from three area hospitals over a two-year period. HCMV is an ubiguitous member of the herpes virus family. Screening will be done using a direct early antigen detection of fluorescent foci (DEAFF) method to identify HCMV in saliva samples of newborns. To assess disease burden, we will document the clinical manifestations in infected infants and determine the distribution of symptomatic vs. asymptomatic presentation using specific case definitions and classification criteria. We will describe the incidence, severity and timing of onset of sensorineural hearing loss (SNHL) over three years in infected infants enrolled in a prospective hearing screening program and determine whether, or the extent to which, universal newborn hearing screening identifies SNHL caused by congenital HCMV infection. In addition, we will describe the development of HCMV-specific CD4 and CD8 T-cell responses of infected infants during the first three years of life to assess differences in immune response patterns between symptomatically and asymptomatically infected infants.