An observational study in Mental Health, Child Wellbeing and Infant Health, sponsored by Murdoch Childrens Research Institute. Recruiting at 1 site in Australia. Open to participants aged 1 Day and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Murdoch Childrens Research Institute · Observational
Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults.
The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.
GenV aims to create large, parallel whole-of-state birth and parent cohorts for discovery and interventional research. The four cornerstones of GenV's first decade are:
Additional foundations activities are:
GenV focuses on 10 big issues: COVID, healthy pregnancy, healthy newborns, equity, climate \& environment, mental health, healthy development, allergy \& immunity, infection, and obesity \& diabetes, with a cross cutting commitment of population genomics. These focus areas drive current planning for data collection but are not intended to be exhaustive and may change over the life of the project.
GenV partnered with all birthing hospitals across Victoria (i.e. 58 hospital sites). In-hospital face-to-face recruitment took place during the newborn period (December 2020 - November 2023). Recruitment visits were completed by trained study staff with clinical and/or research backgrounds, including initial GenV-collected data and biosamples. GenV remains open to eligible families through phone and/or self-guided recruitment.
Participant-provided data are collected digitally (e.g. via website or smart phone app) about four times per year from age 3 months to 1 year, then 6-12 monthly until 5 years, taking 3-20 minutes per session. A face-to-face visit is planned for when the index child is around 6-years of age, completed by trained study staff with clinical and/or research backgrounds. The project duration is expected to be at least 10 years and potentially lifelong for its participants, dependent on study funding and willingness to continue.
GenV estimated that the sampling frame for the main Cohort 2020s would comprise 150,000 children,150,000 birthing parents, and 130,000 (i.e. for 90 percent of children) second parents. GenV's recruitment rate is around 30% of all Victorian families with an eligible child. With a current sample size of 50,000 children, calculations show that this can detect odds ratios of around 1.3 for an outcome with 1.5% prevalence and an exposure with 20% prevalence.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 150,000 is above the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Compared within Wounds and Injuries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
All children living in the state of Victoria, Australia, born between 4th October 2021 and 3rd October 2023, and their parents/guardians.
Inclusion Criteria (Children):
Inclusion Criteria (Adults):
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of parents and children enrolled in the GenV Cohort 2020s
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS)
Time frame: Point of consent until study completion (up to 10 years)
Number of participants with complete data collection at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Time frame: Point of consent until study completion (up to 10 years)
Number of participants with successful data linkage at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV data repository
Time frame: Point of consent until study completion (up to 10 years)
Number of participants with the targeted biosamples received at each wave
Assessed by analysis of records in the study-specific Participant Relationship Management System (PRMS), e-Consent platform and GenV Laboratory Information Management System (LIMS)
Time frame: Point of consent until study completion (up to 10 years)
Number of applications to access and analyse GenV end-user datasets
Assessed by analysis of the GenV data access registry
Time frame: Point of consent until study completion (up to 10 years)
Number of collaborative observational research studies supported
Assessed by analysis of GenV Integrated Studies Register
Time frame: Point of consent until study completion (up to 10 years)
Number of collaborative interventional research studies supported
Assessed by analysis of GenV Integrated Studies Register
Time frame: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent observational research studies embedded within or alongside GenV
Assessed by analysis of shared study participant relationship management system data
Time frame: Point of consent until study completion (up to 10 years)
Number of participants involved in concurrent interventional research studies embedded within or alongside GenV
Assessed by analysis of shared study participant relationship management system data
Time frame: Point of consent until study completion (up to 10 years)
Plan to share: Yes — GenV is designed as an Open Science resource. Privacy-protected child and parent research data will be made available spanning: Individual physical and mental health, education, social and bioassay data Neighbourhood data (eg pollution, childcare) Data will in general be made available after completion and data preparation for entire waves of data collection. An access policy is currently under development. GenV's biosamples are small in volume and depletable. Therefore, bioassay requests are most likely to proceed if they: Are for all participants in GenV (or for the whole subgroup with that biosample) Would be valued by many researchers Generate broad, not hypothesis-specific, biodata (eg -omics panels) Are supported by funding and quality processes.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The first wave of data is expected to become publicly available in 2026. Subsequent releases will follow completed waves of data collection and are expected to be available indefinitely. Limited data are accessible to some collaborators prior to this, for example to support specific operations of integrated studies.
Access criteria: Data will be made available to approved end-users for analyses that achieve the aims in the approved proposal. Approval is based on: The research aims to improve health, development, or wellbeing The proposed use of the data is covered by ethical approval GenV assesses the safety and expertise of the applicant and the institution/organisation Samples/data are used with participant privacy protection in place Users agree to GenV's conditions of use.
Data sharing details ↗ · www.genv.org.au
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Murdoch Childrens Research Institute