CLINICAL TRIAL: HCMV

这个子项目是众多研究子项目之一

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 breastmilk. The rate of HCMV isolation from breastmilk 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 breastmilk 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 breastmilk, there is no method to assure breastmilk is free of infectious HCMV. Transmission of HCMV infection will occur in 37% to 69% of preterm infants fed breastmilk 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.