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临床试验/NCT02139423
NCT02139423已完成不适用

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

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 235 人开始时间: 2014年11月22日最近更新:
适应症
干预措施

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

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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