BEHAVIORAL INTERVENTION FOR CONGENITAL CMV DISEASE

描述：调查人员建议使用行为矫正 孕期预防母婴传播常见的一种 被称为巨细胞病毒(CMV)的病毒。这一点很重要，因为每年 宫内感染巨细胞病毒导致多达8000名婴儿精神障碍 智障和/或聋子。发生这种情况是因为没有免疫力的母亲 (血清阴性)接受日托的幼儿年发病率为 每年近50%的感染率，而不到5%的感染率 在不与托儿所幼儿日常接触的妇女中，这一比例为6%。 如果血清阴性的妇女在怀孕期间感染CMV，则会发生胎儿损害 四分之三的血清阴性母亲怀上了另一个孩子 以前未满30个月的儿童在团体日托中心。至少15 这些儿童中有%的人正在摆脱CMV。调查人员已经 完成了两项试验性研究，以确定行为修改是否减少 巨细胞病毒的母婴传播。他们发现，这种行为 干预措施不太可能对非怀孕妇女有效，但很可能 对孕妇非常有效。 确定孕妇的相对风险真正降低的程度 通过行为干预，并确定动机因素是否 血清阴性孕妇是否知道她的孩子是否正在脱落 巨细胞病毒，血清阴性孕妇将从200个日托中心招募 在美国的五个城市，由日托中心随机分配 给控制组或两个教育组中的一个。世界上的母亲 控制组和一个教育组没有被告知他们的孩子是否 正在剥离CMV。另一个教育小组的母亲知道她们的孩子 状态。这两个教育小组的母亲都将得到关于 防护行为(经常洗手、戴乳胶手套)和危险 避免(与孩子亲密接触)的行为。手套和肥皂的使用 将被监控以间接客观地衡量是否遵守 保护行为。母亲自我报告的保护性和 在整个研究过程中都有危险的行为。这场审判的结果将是 确定行为干预的有效性和动机 有必要坚持建议，防止儿童传染给母亲 巨细胞病毒的传播。

DESCRIPTION: The investigators propose to use behavioral modification during pregnancy to prevent the child-to-mother transmission of a common virus called cytomegalovirus (CMV). This is important because annually intrauterine infection with CMV causes up to 8,000 infants to be mentally retarded and/or deaf. This occurs because mothers without immunity (seronegative) with young children attending day care have annual rates of infection of nearly 50 percent per year compared to a rate of less than five percent among women not in daily contact with young children in day care. Fetal damage occurs if seronegative women acquire CMV during pregnancy and three quarters of seronegative mothers who conceive another child do so with a previous child under 30 months of age in group day care. At least 15 percent of these children are shedding CMV. The investigators have completed two pilot studies to determine if behavioral modification reduced child-to-mother transmission of CMV. They found that behavioral intervention was unlikely to be effective for nonpregnant women but likely to be highly effective for pregnant women. To determine the true reduction in relative risk for pregnant women afforded by behavioral intervention and to determine whether a motivational factor is knowledge by seronegative pregnant mother of whether her child is shedding CMV, seronegative pregnant women will be recruited from 200 day care centers in five cities in the United States and randomly assigned by day care center to either a control group or one of two education groups. Mothers in the control group and one education group are not told whether if their child is shedding CMV. Mothers in the other education group know their child's status. Mothers in both education groups will be given instructions about protective behaviors (frequent hand washing, wearing latex gloves) and risky behaviors to avoid (intimate contact with the child). Glove and soap use will be monitored for an indirect objective measure of adherence to the protective behaviors. Mothers self-report percentages of protective and risky behaviors throughout the study. The results of this trial will determine the effectiveness of behavioral intervention and the motivation necessary to adhere to recommendations and prevent child-to-mother transmission of CMV.