Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns in a Level 3 Maternity Unit During Winter 2025-2026
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Bronchiolitis incidence
研究概览
简要总结
Bronchiolitis is a lower respiratory tract infection, extremely common in pediatrics, and potentially serious. Bronchiolitis affects nearly 30% of infants under 2 years old each year, representing approximately 480,000 cases annually worldwide. Each year, 2 to 3% of infants under 1 year old are hospitalized for bronchiolitis. The virus primarily found worldwide and in France is RSV. Given the scale, frequency, and potential severity of the illness, several immunoprophylaxis methods have been developed.
Currently, there are two methods: the ABRYSVO vaccine, administered to pregnant women during the last month of pregnancy for immunization via the placenta through the transplacental passage of anti-RSV-A and RSV-B antibodies; or neonatal immunoprophylaxis with BEYFORTUS, which involves an intramuscular injection of the monoclonal antibody nirvesimab directly into the newborn immediately before discharge from the maternity ward during the epidemic period.
Currently, no superiority or difference has been described for either immunoprophylaxis method.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 4 Days 至 8 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all term born neonates
排除标准
- •postnatal transfert
- •born at home or in birthing center
结局指标
主要结局
Bronchiolitis incidence
时间窗: 8 months
Number of emergency room visits for bronchiolitis
次要结局
未报告次要终点
研究者
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France
