The Impact of the 2025 Infant and Maternal Respiratory Syncytial Virus (RSV) Prevention Program on RSV-related Hospitalisations in the Australian Capital Territory

NCT07164430 | Completed

• 1 other identifier: 2025.LRE.00223
• Study Type: observational
• Target: 2,792
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Syncytial Virus (RSV) Infection; Respiratory Syncytial Virus Hospitalizations; Respiratory Syncytial Virus Immunization

Keywords

Interrupted Time Series Analysis; Epidemiologic Methods

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

Study Arms (1)

RSV cases

Children aged under 2 years with laboratory confirmed RSV infection

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study is set in the Australian Capital Territory, a small Australian jurisdiction with a single acute paediatric service provider.

You may qualify if:

• child aged under 2 years
• laboratory confirmed RSV

You may not qualify if:

• n/a

Sponsors & Collaborators

• Nicola Irwin: lead
• Kirby Institute: collaborator
• The University of New South Wales: collaborator

Study Sites (1)

The Canberra Hospital

Garran, Australian Capital Territory, 2605, Australia

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Support Nurse

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: September 10, 2025
• Study Start: September 22, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From 3 months after publication of results to 3 years.
• Access Criteria: Researchers with a methodologically sound proposal, subject to ethics and governance processes. A data sharing agreement will be required.

Locations

AU (1)