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