The Australian Respiratory Early Surveillance Team for Cystic Fibrosis (AREST CF) is a multicentre collaborative research study team. The AREST CF Project, started in 2006, is a multi-arm longitudinal study focusing on the assessment, treatment and prevention of CF lung disease, from diagnosis by newborn screening to 9 years of age. The AREST CF Project aims to identify the key drivers of lung disease in the first 5 years of life and targets for intervention, as it is believed that preventing lung damage in early childhood is the best strategy for reducing the impact of lung damage in adult life and improving the lives of patients.

The AREST CF project has a number of study arms:

0 – 6 years: Detection of Early Lung Disease in CF. This longitudinal observational study aims to monitor and assess children with CF from infancy through to 6 years of age. There are two cohorts within this study (see overview for further information). As of August 2016, 412 children have been recruited.

0 – 1 years: Viral Detection sub-study. Since 2013, this sub-study of 0-1 year olds examines the epidemiology of viral infections and the association between early viral illnesses and the development of structural and functional changes in infants with CF. As of August 2016, 73 infants have been recruited from Australia and the USA.

7 – 9 years: Early Predictors and Improved Surveillance of Lung Disease in CF. Started in 2013, this is a follow-up study, to investigate the long term outcomes of lung function from the 0 – 6 years cohorts. As of August 2016, 111 children have enrolled.

Controls: Two groups of children who do not have a diagnosis of CF provide control data and samples; a cross-sectional diagnostic bronchoscopy or bronchoalveolar lavage (BAL) group and a longitudinal lung function group. As of August 2016, there were 253 children aged 0 – 6 years in the cross-sectional group and 95 children aged 3 – 9 years in the longitudinal group.




Group CF 0 – 2 years and preschool (3 – 6 years) Non-CF Bronchoscopy/ BAL Non-CF lung function preschool
Wave W1 W2 W3 W4 W5 W6 W7 W8 W9 W10 N/A Screening Visit 1 Visit 2 Visit 3 Visit 34 (optional)
Age 2 – 4 months 1 year 2 years 3 years 3.5 years 4 years 4.5 years 5 years 5.5 years 6 years 0 – 6 years 3 – 6 years 3 – 6 years Visit 1 + 6 months Visit 1 + 12 months Visit 3 + 12 months
Year 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2006 – ongoing 2010 – ongoing 2014 – ongoing 2014 – ongoing 2014 – ongoing 2014 – ongoing 2014 – ongoing
Allergies Allergies
Anthropometrics
Birth
Condition specific information Condition specific information
Demographics
Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens)
General health
Imaging Imaging Imaging Imaging
Medications and supplements Medications and supplements
Nutrition
Respiratory health
Sleep Sleep
Substance use Substance use Substance use
Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics
Biosamples Biosamples Biosamples Biosamples
Linkage to other database(s)
Visit Screening/ enrolment Visit 1A Baseline Visit 1B Visit 2 Visit 3 Visit 4 Visit 5A Visit 5B Phone interviews (weekly)
Age (3 m ± 1m) (4 m ± 1m) Within 2 weeks of visit 1A (6 m ± 1m) (8 m ± 1m) (10 m ± 1m) (12 m ± 1m) Within 2 weeks of visit 5A Weekly
Year 2013 – 2016 2013 – 2016 2013 – 2016 2013 – 2017 2013 – 2017 2013 – 2017 2014 – 2017 2014 – 2017 2013 – 2017
Anthropometrics
General health
Imaging
Medications and supplements
Respiratory health
Study specific information
Bioanalyses and omics
Biosamples
Group CF school age (7 – 9 years) Non-CF lung function school age
Wave W1 W2 W3 W4 W5 Screening Visit 1 Visit 2 Visit 3
Age 7 years 7.5 years 8 years 8.5 years 9 years 7 – 9 years 7 – 9 years Visit 1 + 6 months Visit 1 + 12 months
Year 2013 – ongoing 2013 – ongoing 2013 – ongoing 2013 – ongoing 2013 – ongoing 2016 – ongoing 2016 – ongoing 2016 – ongoing 2016 – ongoing
Identifiers and miscellaneous Identifiers and miscellaneous Identifiers and miscellaneous
Allergies Allergies Allergies Allergies
Anthropometrics Anthropometrics Anthropometrics
Condition specific information Condition specific information Condition specific information Condition specific information
Demographics Demographics Demographics
Education and childcare Education and childcare Education and childcare
Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens) Environmental exposures (toxins and allergens)
General health General health General health
Imaging Imaging Imaging
Medications and supplements Medications and supplements Medications and supplements Medications and supplements
Mental health Mental health Mental health
Nutrition Nutrition Nutrition
Relationships Relationships Relationships
Resilience and wellbeing Resilience and wellbeing Resilience and wellbeing
Respiratory health
Sleep Sleep Sleep Sleep
Substance use Substance use
Bioanalyses and omics Bioanalyses and omics Bioanalyses and omics
Biosamples Biosamples Biosamples
Linkage to other database(s) Linkage to other database(s) Linkage to other database(s)
Study Summary
Study name AREST CF (Australian Respiratory Early Surveillance Team for Cystic Fibrosis) Early Surveillance Program: Detection of early lung disease in Cystic Fibrosis
Study abbreviation AREST CF
Current principal investigator/s A/Prof Sarath Ranganathan (MCRI)
Prof Stephen Stick (TKI)
Current project manager Andrew Chong (Perth)
Primary Institution Murdoch Children’s Research Institute (MCRI)
Collaborating Institution/s Telethon Kids Institute (TKI)
Major funding sources National Health and Medical Research Council
Murdoch Children’s Research Institute
Royal Children’s Hospital Foundation
Study website www.arestcf.org
Are data available to others outside study team? Yes. Through an application and review process only (through the AREST CF Scientific Management Committee).
Study focus (e.g. social development) Assessment, treatment and prevention of Cystic Fibrosis lung disease in young children.
0 – 6 years sampling frame This is a multi-centre study, with recruitment occurring at:
Royal Children’s Hospital (Melbourne, Australia) and
Princess Margaret Hospital for Children (Perth, Australia)There are two cohorts forming the Detection of Early Lung Disease in CF study arm. The longitudinal inception cohort consists of children diagnosed with CF and recruited before 12 weeks of age and the repeated cross-sectional cohort consists of children diagnosed with CF aged 6 years and under. Participants in both cohorts undergo the same tests, in line with age of recruitment. Recruitment occurs when the child is seen at the hospital or at the respiratory medicine outpatient clinic at the Royal Children’s Hospital (Melbourne) or the Princess Margaret Hospital for Children (Perth).There are two groups of controls (no diagnosis of CF) for this study arm. 1) A cross-sectional diagnostic bronchoscopy or bronchoalveolar lavage (BAL) group provides cross-sectional control samples and data (aged 0 – 6 years). Recruitment is from the Departments of Respiratory Medicine at the Royal Children’s Hospital and the Princess Margaret Hospital for Children. 2) A longitudinal lung function group of preschool children with no history of asthma provide age appropriate longitudinal lung function control data (aged 3 – 6 years). Recruitment is from hospital outpatient clinics, local crèche and child care centres, and online sources. Recruitment is stratified into 3, 4 and 5 year olds, with equal numbers for each age group.
0 – 1 years sampling frame This is a multi-centre study, with recruitment occurring at:
Royal Children’s Hospital (Melbourne, Australia),
Princess Margaret Hospital for Children (Perth, Australia), Riley Hospital for Children (Indianapolis, USA) and
St. Louis Children’s Hospital (Washington University Medical Campus, USA)The Viral Detection sub-study is a sub-study of the longitudinal inception cohort of the Detection of Early Lung Disease in CF study arm. Participants must be enrolled in this component of the study before 12 weeks of age. Additional participants are recruited by teams at Riley Hospital for Children (Indianapolis, USA) and St. Louis Children’s Hospital (USA).
7 – 9 years sampling frame This is a multi-centre study, with recruitment occurring at:
Royal Children’s Hospital (Melbourne, Australia) and
Princess Margaret Hospital for Children (Perth, Australia)Early Predictors and Improved Surveillance of Lung Disease in CF is an extension of the Detection of Early Lung Disease in CF study arm. As a follow-up study, recruitment is limited to the original cohort participants of appropriate age.
A longitudinal lung function group of preschool children with no history of asthma and no diagnosis of CF provide age appropriate longitudinal lung function control data (aged 7 – 9 years). Recruitment is from hospital outpatient, dentistry and orthopaedic clinics and online sources. Recruitment is stratified into 7, 8 and 9 year olds, with equal numbers for each age group.
Study type (e.g. randomised control trial, cohort, case-control) Cohort study
Year commenced 2004 (Perth), 2005 (Melbourne).
Ongoing recruitment? Yes
Current sample (N) As of August 2016:
CF cases: 412 (164 from Melbourne)
Controls: 95 for Lung Function Test and 253 for BAL/Bronchoscopy
Annual recruitment rate 23
Intergenerational (e.g. offspring)? No
Imaging (e.g. fMRI, ultrasound, retinal photograph)? Yes.
Chest CT (at 1, 3 and 5 years of age)
Spirometry Controlled Chest CT (at 7 and 9 years of age)
Linkage (e.g. BioGrid, VPDC, NAPLAN, Medicare)? No
Biosamples (e.g. buccal, blood, hair)? Blood
Faeces
Urine
Bronchoalveoloar lavage fluid
Bronchial Brushings
Oropharyngeal Swabs
Induced Sputum
Ethics approvals or requirements (e.g. specific, extended, unspecified, other)?
Year Study Eligible sample (not deceased, not withdrawn)
2004 – ongoing 0 – 6 years Cases: 412 (0 – 6 years)
Controls: 253 (3 – 6 years)
2013 – ongoing 0 – 1 years sub-study 29 (Melbourne)
22 (Perth)
15 (Indianapolis, USA)
7 (Washington, USA)
2013 – ongoing 7 – 9 years Cases: 56 (Melbourne)
55 (Perth)
Controls: Target of 50 (Melbourne)
34 (Perth)

Principal Investigator

Prof Sarath Ranganathan (MCRI)
Prof Stephen Stick (TKI)

Project Manager

Andrew Chong (Perth)

Study Contact

Louise King
Ph: +613 9936 6518
Email: louise.king@mcri.edu.au

Postal Address

Respiratory and Sleep Medicine Department
Royal Children’s Hospital
50 Flemington Rd
Parkville VIC 3052
Australia