Congenital Cytomegalovirus Infection by Detection of the Virus in the Saliva of Newborns at Particular Risk: A Retrospective Population-based Study Between February 2019 and December 2021 at the Regional Maternity Hospital of Nancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Relevance of the Protocol for defining a population at risk
研究概览
简要总结
Congenital CMV infection is the leading cause of non-genetic deafness and neurodevelopmental disorders. Its prevalence in France is estimated between 0.3% and 1% of births depending on the study.
Congenital infection is symptomatic in 10% of cases with a large clinical spectrum with different degree of severity. These sequelae develop progressively and fluctuate, which justifies prolonged follow-up of children for several years, even if they are asymptomatic at birth.
There is yet no treatment with AMM in neonates or pregnant women. In France, screening for congenital CMV infection is widely debated. It remains oriented to certain newborns considered at risk or depending on their symptoms and varies with the practices of each Neonatology or Maternity Hospital.
In the Regional Maternity of Nancy, a new screening protocol for congenital CMV infection was implemented from early 2019.
It is based on screening by non-invasive salivary test (CMV PCR) in newborns at particular risk who are included in a registry open for this screening.
The aim of this research was to assess the relevance of the proposed criteria in the Protocol for defining a population at risk of congenital CMV infection thus qualifying for CMV screening. The secondary endpoints are the modalities of the screening test, the evaluation of each risk factor for infection, and the study of affected patients (symptoms, therapeutic intervention, neurological and auditory outcome).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 3 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn born between Bebruary 2019 and December 2021 in the Regional Maternity Hospital of Nancy
- •Patients who were screened for congenital CMV infection by salivary PCR
排除标准
- 未提供
结局指标
主要结局
Relevance of the Protocol for defining a population at risk
时间窗: baseline
Comparison between Prevalence in the targeted population and Prevalence in the general Population
次要结局
- Modalities of realisation of screening test(baseline)
- Maternal CMV infection as a Risk Factor for Congenital CMV Infection(baseline)
- Microcephaly as a Risk Factor for Congenital CMV Infection(baseline)
- Any foetal ultrasound abnormality as a Risk Factor for Congenital CMV Infection(baseline)
- Hypotrophy as a consequence of diagnosed Congenital CMV Infection(baseline)
- Hypotrophy as a Risk Factor for Congenital CMV Infection(baseline)
- Biological hepatic abnormality as a Risk Factor for Congenital CMV Infection(baseline)
- Hearing abnormality as a Risk Factor for Congenital CMV Infection(baseline)
- Hearing abnormality as a consequence of Congenital CMV Infection(baseline)
- Any neurological abnormality as a consequence of Congenital CMV Infection(baseline)
- Any neurological abnormality as a Risk Factor for Congenital CMV Infection(baseline)
- Any blood count cell abnormality as a Risk Factor for Congenital CMV Infection(baseline)
- Any blood count cell abnormality as a consequence of Congenital CMV Infection(baseline)
- Presence of Hepatomegaly or splenomegaly as a Risk Factor for Congenital CMV Infection(Baseline)
- Microcephaly as a consequence of diagnosed Congenital CMV Infection(baseline)
- Biological hepatic abnormality as a consequence of Congenital CMV Infection(baseline)
研究者
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France