Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kirby Institute | OTHER_GOV |
| The University of New South Wales | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV cases | Children aged under 2 years with laboratory confirmed RSV infection |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| RSV Hospitalisation | 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. | At monthly time intervals over 3 years and 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Emergency Department presentations | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia |
Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes.
From 3 months after publication of results to 3 years.
Researchers with a methodologically sound proposal, subject to ethics and governance processes. A data sharing agreement will be required.
Not provided
Not provided
Not provided
Not provided
| Monthly time intervals over a period of 3 years and 8 months |
| RSV cases | 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. | At monthly intervals over 3 years and 8 months |
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided