跳至主要内容
临床试验/NCT07335874
NCT07335874招募中不适用

Overview of Targeted Screening for Congenital Infection Guided by Neonatal Hearing Screening

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2025年6月16日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
450
试验地点
1
主要终点
CMV PCR rates (in %) in infants with inconclusive T2 at the newborn hearing screening (DNS)

研究概览

简要总结

Cytomegalovirus (CMV) infection is the most common congenital infection. It is the second leading cause of sensorineural hearing loss after genetic causes and the leading cause of motor delay. It can also cause ophthalmological or biological abnormalities (hepatic cytolysis, thrombocytopenia, etc.). Currently, routine screening during pregnancy or at birth is not recommended.

90% of infected infants are asymptomatic at birth. However, 10 to 25% of them present with hearing loss at birth or will develop it in their first years of life. This hearing loss is progressive.

In the context of deafness, detecting congenital CMV infection helps explain the cause of hearing loss (a recurring question from parents) and allows for tailored management and follow-up (progressive deafness, bilateral involvement). Its detection also enables appropriate pediatric monitoring (neurological, ophthalmological, etc.). Screening for congenital CMV infection (cCMV), guided by neonatal hearing screening, has been recommended by the French High Council for Public Health (HCSP) since 2018.

In cases of confirmed congenital CMV infection, an ophthalmological examination (fundus examination), hearing test, brain imaging, and blood tests are performed.

The investigators wish to collect data from targeted screening for congenital CMV infection at the Strasbourg University Hospitals (HUS) to ensure comprehensiveness and to study CMV-related conditions in these screened children.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
0 Years 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Minors aged 0 to 1 month at the time of newborn hearing screening
  • Subject with inconclusive newborn hearing screening (NHS) on unilateral or bilateral T2 (inconclusive retest) between August 2024 and the end of July 2025.

排除标准

  • Positive CMV PCR after 1 month of life
  • CMV PCR performed for another indication.

结局指标

主要结局

CMV PCR rates (in %) in infants with inconclusive T2 at the newborn hearing screening (DNS)

时间窗: Up to 12 months

CMV PCR rates in infants with inconclusive T2 at the newborn hearing screening (DNS) (number of PCR tests performed / total number of infants with inconclusive T2)

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验