Respiratory Syncytial Virus Hospitalizations, Respiratory Syncytial Virus Immunization, Respiratory Syncytial Virus (RSV) Infection
Conditions
Keywords
Interrupted Time Series Analysis, Epidemiologic Methods
Brief summary
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.
Detailed description
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: 1. Evaluate the impact of the 2025 RSV prevention program on RSV-related Emergency Department (ED) presentations 2. Evaluate the impact on the reported incidence of RSV
Interventions
None listed
Sponsors
Nicola Irwin
Kirby Institute
The University of New South Wales
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* child aged under 2 years * laboratory confirmed RSV
Exclusion criteria
* n/a
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RSV Hospitalisation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emergency Department presentations | Monthly time intervals over a period of 3 years and 8 months | RSV-related ED presentations will be determined by reviewing ED presentations occurring within one month of a positive RSV test. Documentation from the presentation will be reviewed for a discharge diagnosis or impression consistent with RSV-related illness (bronchiolitis, respiratory tract infection, viral illness). If no discharge letter or doctors' documentation is available, the triage note will be reviewed for a presenting complaint consistent with RSV-related illness (rhinorrhoea, nasal congestion, cough, respiratory distress, diffuse crackles and/or wheeze, fever, hypoxaemia, and associated feeding difficulties, vomiting, dehydration, or lethargy). |
| RSV cases | At monthly intervals over 3 years and 8 months | RSV cases will be determined by laboratory notifications of positive RSV infection on PCR test to ACT Health, the body responsible for receiving notifiable disease notifications. |
Countries
Australia
Outcome results
None listed