Feasibility to Achieve, Before One Month of Age, the Diagnosis of Congenital CMV Diagnosis and the Formal Audiologic Assessment in Newborns Who Failed Newborn Hearing Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
研究概览
简要总结
Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
详细描述
Congenital cytomegalovirus (cCMV) is the most frequent congenital infection in France. Around 90% of cCMV infected infants are asymptomatic at birth, of whom 7 to 20% develop sensorineural hearing loss (SNHL). cCMV explains at least 10% of all hearing loss cases in young children. Early antiviral treatment (implemented before 1 month of age) with ganciclovir or valganciclovir can improve hearing outcome. In the absence of universal screening, cCMV remains largely undetected because most infected neonates are asymptomatic or have non-specific symptoms. When symptoms become apparent or develop, it may be too late for confirmation that the infection is of congenital origin becausediagnosis of congenital infection is based on the detection of CMV in samples collected within 2 to 3 weeks after birth. The presence of CMV in samples collected after this time may represent postnatal infection which does not carry the risk of hearing loss or neurodevelopmental sequelae. Universal hearing screening at birth by use of otoacoustic emission (OAE) is now offered in most maternities in France to detect symptomatic hearing impairment at birth but screening of cCMV infection is not coupled with this screening. In this study, the feasibility of achieving before one month of age the diagnosis of congenital CMV diagnosis and as well as the confirmation of hearing loss in newborns who failed newborn hearing screening will be tested.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 10 Days(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All newborns who have failed universal newborn screening
排除标准
- •Neonates whose mothers would object to the use of their child's medical data
研究组 & 干预措施
All newborns who fail universal newborn
CMV PCR
干预措施: CMV PCR (Other)
结局指标
主要结局
Number of days necessary to obtain the result of cCMV infection diagnosis and the audiological result after formal assessment
时间窗: 1 month
次要结局
- Measurement of CMV by quantitative PCR(4 months)
- Number of children with cCMV infection and confirmed hearing loss in whom antiviral therapy has been initiated within the first month of life(4 months)
- Number of children for whom the result of the formal audiological assessment has been obtained(4 months)
