The Impact of Infant and Maternal Immunoprophylaxis on Hospitalisation for Respiratory Syncytial Virus in the Australian Capital Territory: A Population-based Interrupted Time Series Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,792
- 试验地点
- 1
- 主要终点
- RSV Hospitalisation
研究概览
简要总结
The goal of this observational study is to is to examine the impact of new RSV prevention medicines on the burden of RSV disease among young children. The main question it aims to answer is:
What was the impact of the 2025 RSV prevention program on RSV-related hospitalisation in children under 2 years of age?
Participants won't need to do anything additional for the study as only routinely collected health information will be used to answer the research question.
详细描述
Nirsevimab, a novel long-acting monoclonal antibody targeted at RSV became available for vulnerable babies in the Australian Capital Territory (a small jurisdiction in Australia) in April 2024. Maternal RSV vaccine, Abrysvo, became available for all women of 28-36 weeks gestation in February 2025. Through either nirsevimab or Abrysvo, all infants born from 1 January 2025 in the jurisdiction have universal eligibility for RSV immunoprophylaxis.
This study will use interrupted time series methodology to evaluate the impact of the 2025 RSV prevention program on RSV-related hospitalisation in children under 2 years of age. Historical data from 2022-2023 will form the pre-nirsevimab period, and 2022-2024 the pre-Abrysvo period. 2025 will form the post-intervention period.
Secondary objectives are to:
- Evaluate the impact of the 2025 RSV prevention program on RSV-related Emergency Department (ED) presentations
- Evaluate the impact on the reported incidence of RSV
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child aged under 2 years
- •laboratory confirmed RSV
排除标准
- 未提供
研究组 & 干预措施
RSV cases
Children aged under 2 years with laboratory confirmed RSV infection
结局指标
主要结局
RSV Hospitalisation
时间窗: At monthly time intervals over 3 years and 8 months
RSV-related hospital admissions will be determined by reviewing hospital admissions occurring within one month of a positive RSV test. The discharge summary will be reviewed for a diagnosis or other clinical information consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness), and cross-checked with the ICD-10-AM coding for the episode.
次要结局
- Emergency Department presentations(Monthly time intervals over a period of 3 years and 8 months)
- RSV cases(At monthly intervals over 3 years and 8 months)
研究者
Nicola Irwin
Clinical Support Nurse
The Canberra Hospital