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临床试验/NCT07251972
NCT07251972进行中(未招募)不适用

Comparison of Two Methods of Immunoprophylaxis Against RSV in Term Newborns in a Level 3 Maternity Unit During Winter 2025-2026

Jean-Michel HASCOET1 个研究点 分布在 1 个国家目标入组 1,050 人开始时间: 2025年9月1日最近更新:
适应症
相关药物

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

发起方
Jean-Michel HASCOET
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

研究点 (1)

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