HCMV

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。人类巨细胞病毒（HCMV）是疱疹病毒群的一员。在HCMV血清阳性的妇女中，潜伏的HCMV感染会再次激活，随后会脱落到母乳中。从母乳中分离HCMV的比率根据乳汁类型、检测频率和病毒分离方法而有所不同。在0.6%至13%的初乳标本中检测到HCMV；血清阳性妇女的成熟乳样本中有32%至96%含有HCMV。从母乳样本中实验室分离HCMV耗时、技术困难且不标准化。目前，对于有兴趣用自己母亲的母乳喂养早产、低出生体重婴儿的医生来说，没有办法确保母乳中没有传染性HCMV。在HCMV血清阳性母亲喂养的母乳中，37%至69%的早产儿会发生HCMV感染传播。母乳喂养的早产儿出现症状性HCMV感染的频率尚未得到令人信服的证实。在报道的文献中，没有包括适当的控制，共存的细菌病原体被忽视。缺乏治疗母乳的标准政策进一步复杂化了早产儿、低出生体重儿HCMV感染的研究。本研究将检查母乳喂养的早产儿、低出生体重儿的HCMV感染情况。本研究分为两部分，分别针对出生体重小于1500克或妊娠32周前出生的婴儿进行不同的研究设计。对于研究的横断面部分，主要终点是一年内或一年前尿HCMV脱落的患病率。该研究的前瞻性观察部分，主要终点是HCMV传播给喂养新鲜冷冻、表达的母乳的早产儿、低出生体重儿的发生率。次要终点将被检查，以允许比较早产儿低出生体重婴儿的临床过程，喂养自己的HCMV血清阳性母亲的新鲜冷冻母乳与喂养自己的HCMV血清阴性母亲的母乳的临床过程。对于这两个研究部分，将检查以下次要终点：1)记录感染，2)呼吸支持和3)抗菌药物使用。预计患者总数包括230名婴儿和230名母亲，共计460人。

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. Human cytomegalovirus (HCMV) is a member of the herpes virus group. In HCMV seropositive women, reactivation of latent HCMV infection occurs with subsequent shedding into breast milk. The rate of HCMV isolation from breast milk varies according to the type of milk, frequency of testing, and methods of viral isolation. HCMV is detected in 0.6% to 13% of colostrum specimens; 32% to 96% of mature milk samples from seropositive women contain HCMV. Laboratory isolation of HCMV from breast milk samples is time-consuming, technically difficult and not standardized. Currently, for physicians interested in feeding premature, low birth weight infants their own mother's expressed breast milk, there is no method to assure breast milk is free of infectious HCMV. Transmission of HCMV infection will occur in 37% to 69% of preterm infants fed breast milk from HCMV seropositive mothers. The frequency of symptomatic HCMV infection in preterm infants fed maternal breast milk has not been established convincingly. In the reported literature, appropriate controls have not been included and co-existing bacterial pathogens have been disregarded. Lack of a standard policy for treatment of expressed breast milk further complicates research on HCMV infection in preterm, low birth weight infants. This study will examine HCMV infection in preterm, low birth weight infants fed maternal breast milk. This study is divided into two parts with different study designs for infants with birth weights less than 1500 grams or delivered before 32 weeks gestation. For the cross-sectional part of the study, the primary endpoint is the prevalence of urine HCMV shedding as or before one year. For the prospective observational part of the study, the primary endpoint is the incidence of HCMV transmission to premature, low birth weight infants fed fresh frozen, expressed maternal breast milk. Secondary endpoints will be examined in order to permit the comparison of the clinical course of premature low birth weight infants fed their own HCMV seropositive mother's fresh frozen breast milk to the clinical course of infants fed their own HCMV seronegative mother's breast milk. For both study parts, the following secondary endpoints will be examined: 1) documented infections, 2) respiratory support, and 3) antimicrobial usage. Total patients expected include 230 infants and 230 mothers for a total of 460.