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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07164430
Registration number
NCT07164430
Ethics application status
Date submitted
4/09/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Titles & IDs
Public title
The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory
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Scientific title
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
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Secondary ID [1]
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2025.LRE.00223
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus (RSV) Infection
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Respiratory Syncytial Virus Hospitalizations
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Respiratory Syncytial Virus Immunization
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
RSV cases - Children aged under 2 years with laboratory confirmed RSV infection
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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RSV Hospitalisation
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Assessment method [1]
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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.
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Timepoint [1]
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At monthly time intervals over 3 years and 8 months
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Secondary outcome [1]
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Emergency Department presentations
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Assessment method [1]
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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).
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Timepoint [1]
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Monthly time intervals over a period of 3 years and 8 months
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Secondary outcome [2]
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RSV cases
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Assessment method [2]
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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.
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Timepoint [2]
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At monthly intervals over 3 years and 8 months
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Eligibility
Key inclusion criteria
* child aged under 2 years
* laboratory confirmed RSV
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Minimum age
No limit
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Maximum age
2
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* n/a
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/09/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
2100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT
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Recruitment hospital [1]
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The Canberra Hospital - Garran
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Recruitment postcode(s) [1]
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2605 - Garran
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Funding & Sponsors
Primary sponsor type
Other
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Name
Nicola Irwin
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT07164430
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Nicola Irwin, PhD
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Address
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Country
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Phone
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+61 481 396 197
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Deidentified IPD that underlie any published results may be shared upon reasonable request, and subject to ethics and governance processes.
Supporting document/s available: Study protocol
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When will data be available (start and end dates)?
From 3 months after publication of results to 3 years.
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Available to whom?
Researchers with a methodologically sound proposal, subject to ethics and governance processes. A data sharing agreement will be required.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.act.gov.au/open/act-data-sharing-policy
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07164430
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