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Trial registered on ANZCTR


Registration number
ACTRN12624001361594
Ethics application status
Approved
Date submitted
24/10/2024
Date registered
13/11/2024
Date last updated
13/11/2024
Date data sharing statement initially provided
13/11/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Children and Adolescents: Respiratory Infection and Long-term Effects (CARE Study)
Scientific title
A longitudinal study of post-viral sequelae following common respiratory infections in children and adolescents
Secondary ID [1] 313226 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CARE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 virus 335526 0
Influenza virus 335527 0
Condition category
Condition code
Infection 332093 332093 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
Children and adolescents aged 0 to 17 who have tested positive for COVID-19 or influenza are eligible for enrollment. Those who consent will be asked to complete a baseline, 3-month, 6-month, and 12-month online survey. Each online survey takes approximately 10 minutes. Participants are enrolled in the study for 12 months.
Intervention code [1] 329801 0
Not applicable
Comparator / control treatment
Post-acute sequelae following influenza (comparator group) will be compared with post-acute sequelae following COVID-19.
Control group
Active

Outcomes
Primary outcome [1] 339684 0
Incidence of post-acute sequelae in children and adolescents with COVID-19 infection
Timepoint [1] 339684 0
3, 6, and 12 months post-infection
Secondary outcome [1] 440878 0
Incidence of post-acute-sequelae in children and adolescents following influenza infection
Timepoint [1] 440878 0
3, 6, and 12 months post-infection
Secondary outcome [2] 440880 0
Identify risk factors for the development of post-acute sequelae for children and adolescents with COVID-19
Timepoint [2] 440880 0
3, 6, and 12 months post-infection
Secondary outcome [3] 440881 0
Quality of life of children and adolescents (aged 2-18) experiencing post-acute sequelae compared to those without post-acute sequelae in COVID-19-positive cases.
Timepoint [3] 440881 0
3, 6, and 12 months post-infection
Secondary outcome [4] 440882 0
Fatigue of children and adolescents (aged 2-18) experiencing post-acute sequelae compared to those without post-acute sequelae in COVID-19-positive cases.
Timepoint [4] 440882 0
3, 6, and 12 months post-infection
Secondary outcome [5] 440883 0
Quality of life of children and adolescents (aged 2-18) experiencing post-acute sequelae, compared to those without, following influenza infection.
Timepoint [5] 440883 0
3, 6, and 12 months post-infection
Secondary outcome [6] 440884 0
Fatigue scores of children and adolescents (aged 2-18) experiencing post-acute sequelae, compared to those with post-acute sequelae following influenza infection.
Timepoint [6] 440884 0
3, 6, and 12 months post-infection
Secondary outcome [7] 440964 0
School/childcare absenteeism in COVID-19 cases with post-acute sequelae compared to those without sequelae
Timepoint [7] 440964 0
3, 6, and 12 months post-infection
Secondary outcome [8] 440966 0
School/childcare absenteeism in COVID-19 cases with post-acute sequelae compared to those with post-acute sequelae following influenza
Timepoint [8] 440966 0
3, 6, and 12 months post-infection
Secondary outcome [9] 440968 0
The incidence of post-acute sequelae in those with repeat COVID-19 infections, compared to those with one, as well as those with none,
Timepoint [9] 440968 0
3, 6, and 12 months post-infection
Secondary outcome [10] 440970 0
Influenza vaccine uptake in children and adolescents with post-acute sequelae, compared to vaccination uptake in those without.
Timepoint [10] 440970 0
3, 6, and 12 months post-infection
Secondary outcome [11] 441154 0
Duration of post-acute sequelae in children and adolescents with COVID-19 infection
Timepoint [11] 441154 0
3, 6, and 12 months post-infection
Secondary outcome [12] 441155 0
Type of post-acute sequelae in children and adolescents with COVID-19 infection
Timepoint [12] 441155 0
3, 6, and 12 months post-infection
Secondary outcome [13] 441156 0
Duration of post-acute-sequelae in children and adolescents following influenza infection
Timepoint [13] 441156 0
3, 6, and 12 months post-infection
Secondary outcome [14] 441157 0
Type of post-acute-sequelae in children and adolescents following influenza infection
Timepoint [14] 441157 0
3, 6, and 12 months post-infection

Eligibility
Key inclusion criteria
Children and adolescents aged 0 to 17 who have tested SARS-CoV-2 positive (PCR or Rapid Antigen Tests) or influenza (PCR or Rapid Antigen Tests) in the previous 2 months are eligible for enrollment.
Minimum age
0 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Inability to give informed consent
2) No mobile phone number

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics will be reported for the incidence of post-acute sequelae following COVID-19 and influenza infection in South Australian children and adolescents.

Linear mixed effects models will be used to assess differences between groups.

A prediction model will be developed using the transparent reporting of a multivariable prediction model for individual prognosis or diagnosis (TRIPOD) guidelines. Multiple imputation will be applied dependent on the amount and reasons for missing data.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/06/2024
Date of last participant enrolment
Anticipated
20/03/2026
Actual
Date of last data collection
Anticipated
20/03/2027
Actual
Sample size
Target
4000
Accrual to date
112
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317668 0
Charities/Societies/Foundations
Name [1] 317668 0
Women’s & Children’s Hospital Foundation
Country [1] 317668 0
Australia
Primary sponsor type
Government body
Name
Women's and Children's Hospital Network
Address
Country
Australia
Secondary sponsor category [1] 320008 0
None
Name [1] 320008 0
Address [1] 320008 0
Country [1] 320008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316368 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 316368 0
https://www.wchn.sa.gov.au/research/human-research
Ethics committee country [1] 316368 0
Australia
Date submitted for ethics approval [1] 316368 0
20/11/2023
Approval date [1] 316368 0
02/04/2024
Ethics approval number [1] 316368 0
2023/HRE00283

Summary
Brief summary
This study investigates ongoing symptoms following COVID-19 and influenza infections in children and teenagers.

Parents of children who have had COVID-19 or influenza will be invited to participate. Initially, cases will be identified through presentations at the Women's and Children's Hospital and will then expand to include statewide notifications.

After providing consent, participants (or their parents) will complete surveys at the start of the study and then again at 3, 6, and 12 months after the viral infection. These surveys will help researchers monitor any persistent health issues over time.

The primary goal of the study is to understand how common these ongoing health problems are in young people and how they impact their daily lives.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137670 0
Dr Mark McMillan
Address 137670 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006
Country 137670 0
Australia
Phone 137670 0
+61 08 81618117
Fax 137670 0
Email 137670 0
[email protected]
Contact person for public queries
Name 137671 0
Mark McMillan
Address 137671 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006
Country 137671 0
Australia
Phone 137671 0
+61 08 81618117
Fax 137671 0
Email 137671 0
[email protected]
Contact person for scientific queries
Name 137672 0
Mark McMillan
Address 137672 0
Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006
Country 137672 0
Australia
Phone 137672 0
+61 08 81618117
Fax 137672 0
Email 137672 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification; individual participant data underlying published results only.
When will data be available (start and end dates)?
20/09/2027 to 20/09/2029
Available to whom?
IPD will be made available on a case-by-case basis at the discretion of the Investigator Committee and WCHN HREC.
Available for what types of analyses?
IPD data will only be available to achieve the aims in the approved proposal.
How or where can data be obtained?
Principal Investigator (contact details listed). [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.