ANZCTR - Registration

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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]

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

Influenza virus

Condition category

Condition code

Infection

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]

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]

Incidence of post-acute sequelae in children and adolescents with COVID-19 infection

Timepoint [1]

3, 6, and 12 months post-infection

Secondary outcome [1]

Incidence of post-acute-sequelae in children and adolescents following influenza infection

Timepoint [1]

3, 6, and 12 months post-infection

Secondary outcome [2]

Identify risk factors for the development of post-acute sequelae for children and adolescents with COVID-19

Timepoint [2]

3, 6, and 12 months post-infection

Secondary outcome [3]

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]

3, 6, and 12 months post-infection

Secondary outcome [4]

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]

3, 6, and 12 months post-infection

Secondary outcome [5]

Quality of life of children and adolescents (aged 2-18) experiencing post-acute sequelae, compared to those without, following influenza infection.

Timepoint [5]

3, 6, and 12 months post-infection

Secondary outcome [6]

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]

3, 6, and 12 months post-infection

Secondary outcome [7]

School/childcare absenteeism in COVID-19 cases with post-acute sequelae compared to those without sequelae

Timepoint [7]

3, 6, and 12 months post-infection

Secondary outcome [8]

School/childcare absenteeism in COVID-19 cases with post-acute sequelae compared to those with post-acute sequelae following influenza

Timepoint [8]

3, 6, and 12 months post-infection

Secondary outcome [9]

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]

3, 6, and 12 months post-infection

Secondary outcome [10]

Influenza vaccine uptake in children and adolescents with post-acute sequelae, compared to vaccination uptake in those without.

Timepoint [10]

3, 6, and 12 months post-infection

Secondary outcome [11]

Duration of post-acute sequelae in children and adolescents with COVID-19 infection

Timepoint [11]

3, 6, and 12 months post-infection

Secondary outcome [12]

Type of post-acute sequelae in children and adolescents with COVID-19 infection

Timepoint [12]

3, 6, and 12 months post-infection

Secondary outcome [13]

Duration of post-acute-sequelae in children and adolescents following influenza infection

Timepoint [13]

3, 6, and 12 months post-infection

Secondary outcome [14]

Type of post-acute-sequelae in children and adolescents following influenza infection

Timepoint [14]

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]

Charities/Societies/Foundations

Name [1]

Women’s & Children’s Hospital Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Women's and Children's Hospital Network

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

https://www.wchn.sa.gov.au/research/human-research

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/11/2023

Approval date [1]

02/04/2024

Ethics approval number [1]

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

Dr Mark McMillan

Address

Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006

Country

Australia

Phone

+61 08 81618117

Fax

Email

mark.mcmillan@adelaide.edu.au

Contact person for public queries

Name

Mark McMillan

Address

Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006

Country

Australia

Phone

+61 08 81618117

Fax

Email

mark.mcmillan@adelaide.edu.au

Contact person for scientific queries

Name

Mark McMillan

Address

Women's and Children's Hospital, 72 King William Rd, North Adelaide, SA, 5006

Country

Australia

Phone

+61 08 81618117

Fax

Email

mark.mcmillan@adelaide.edu.au

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). mark.mcmillan@adelaide.edu.au

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.