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Trial registered on ANZCTR
Registration number
ACTRN12625000660482p
Ethics application status
Submitted, not yet approved
Date submitted
4/06/2025
Date registered
23/06/2025
Date last updated
23/06/2025
Date data sharing statement initially provided
23/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The Efficacy of Airway Clearance Techniques in children with chronic suppurative lung diseases: a randomised controlled trial
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Scientific title
The Efficacy of Airway Clearance Techniques on cough resolution in children with chronic suppurative lung diseases: a randomised controlled trial
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Secondary ID [1]
314598
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
E-ACT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic suppurative lung disease
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Protracted bacterial bronchitis
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Condition category
Condition code
Infection
334147
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0
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Other infectious diseases
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Respiratory
334051
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consists of an airway clearance program prescribed by a physiotherapist with clinical experience in chronic respiratory disease management in children at the study site.
Prescription of one or a combination of the following airway clearance programs, depending on age and ability of patient and carer. For children aged >2years, TherabubbleTM or Hydrapep (PEP) will be trialled at the initial consultation with the physiotherapist. In general, once the child is old enough to be able to coordinate undertaking PEP, this program will be prescribed preferentially over manual techniques. Where the child is unable to coordinate the PEP therapy (i.e., usually <2-years), manual techniques and/or active breathing techniques will be undertaken. The duration is 10-15minutes, twice a day, until 1-week post cough resolution.
1. TherabubbleTM or Hydrapep are TGA approved devices. Both devices are a form of positive expiratory pressure airway clearance. The duration is 10-15minutes, twice a day, until 1-week post cough resolution. The 10-15minute program includes sets of breaths for approximately 3-4 seconds exhalation. The physiotherapist may suggest sets of 5-10 sets of 10-15 breaths followed by huff and cough or time the sets for 3-5minutes each, depending on suitability with the patient again with each set being followed with huff and cough.
2. Manual techniques: Percussion is performed by the carer who has received instructions on the technique. The carer is taught how to undertake percussion in six possible positions. The carer is taught to undertake 10-15min twice a day. A huff (if able) and cough are encouraged at least three times during each session, if the child is old enough to understand.
3. Modified active breathing techniques: Deep breathing with active play using whistles, bubbles and balloons. The carer will be taught how to integrate active play with deep breathing with the use of bubbles, whistles and balloons for 10-15minutes twice daily. A huff (if able) and cough is encouraged at least three times during each session, if the child is old enough to understand.
Note: Both Therabubble and Hydrapep are positive expiratory pressure therapies in the form of a plastic, multi-use (but for same patient only) bottle device. The bottle has a sealed lid, with a tubing (10mm diameter), which sits at the bottom of the bottle and then above the sealed lid so that the patient can blow into the tubing. The resistance with the apparatus is created by a water seal. The patient sits at a table and the bottle is filled to the correct level. The patient holds the tubing with one hand and then puts the end of the tubing in their mouth, seals the lips around the tubing and takes a slightly larger than tidal volume breath and breaths out for the 3-4 seconds. The patient is essentially blowing out against the resistance of the water, and this creates a "back pressure" or positive pressure which moves the secretions to where the patient can cough them up.
All airway clearance programs will be taught in an outpatient clinic setting at either a hospital or private respiratory clinic. The duration of the teaching session will be a single session of 45minutes to 1-hour duration. Airway clearance will then be performed by the parent/carer independently at home each day for the duration specified by the physiotherapist.
Strategies to assess adherence are a daily diary where the parent reports if airway clearance was performed and for how long.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Devices
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Comparator / control treatment
Standard care - oral antibiotic therapy for prescribed duration - expected to be two-six weeks depending on patient requirement.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome will be the proportion of children with cough resolution by day-10
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Assessment method [1]
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Validated cough score Daytime Verbal Category Descriptive 0 = No cough, 1 = cough for one or two short periods only, 2 = cough for more than two short periods, 3 = frequent coughing but does not interfere with school or other activities, 4 = frequent coughing which interferes with school or other activities, 5 = cannot perform most usual activities due to severe coughing
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Timepoint [1]
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Day 10 post intervention commencement
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Secondary outcome [1]
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1. The time to next exacerbation
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Assessment method [1]
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Cough diary and phone call follow-up
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Timepoint [1]
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Once monthly, for up to 12-months from enrolment
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Secondary outcome [2]
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Change in Cough-related Quality of Life (PC-QoL)11 from day 1 to day 10 and 28
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Assessment method [2]
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Parent proxy cough-related quality of life survey - 8 question validated tool.
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Timepoint [2]
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survey undertaken at enrolment and then day 10 and day 28 following enrolment
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Secondary outcome [3]
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Days to cough clearance
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Assessment method [3]
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Cough diary and telephone review
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Timepoint [3]
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Daily (via online cough diary) and telephone review at day-10 and day-28 following enrolment
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Eligibility
Key inclusion criteria
Meeting the diagnostic criteria for suspected or confirmed protracted bacterial bronchitis (PBB) or chronic suppurative lung disease (CSLD)
Aged between 0-16 years age
Receiving routine standard treatment with oral antibiotic therapy
Voluntarily agreeing to participate
Ability to understand English
Note: Children with mild hypotonia, mild developmental delay and mild aspiration are not excluded in the study and airway clearance technique will be prescribed to mitigate aspiration risk e.g., airway clearance performed prior to feeding.
CT or chest cray changes as follows are included: peribronchial wall thickening and gas trapping/mucus plugging, tracheo-bronchomalacia, subpleural bleb and atelectasis
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Minimum age
1
Months
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Presence of other chronic respiratory illness (other than asthma) such as bronchiectasis, primary ciliary dyskinesia, cystic fibrosis
Children with neurological Gross Motor Function classification of V or other severe neuromuscular disability affecting the child’s ability to follow instructions related to breathing and coughing to command
Contraindications for airway clearance such as recent haemoptysis, recent facial surgery, current rib fracture, recent open-heart surgery
Chest Xray or CT abnormality other than peribronchial wall thickening and gas trapping/mucus plugging, tracheo-bronchomalacia, subpleural bleb and atelectasis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated using the Sealed Envelope platform (www.sealedenvelope.com),
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The computer-generated randomisation will be stratified by age (6years) using permuted blocks (randomly alternating between block sizes of 4 and 6). (The 1:1 allocation sequence will be prepared by an independent statistician, using the Sealed Envelope platform (www.sealedenvelope.com), and will be preloaded into the studies REDCap database. This means participants assigned group will be revealed by REDCap following consent.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Data will be exported from REDCap and processed into the form of one record per participant. Basic descriptive statistics will be used to describe and characterise the data, including reporting means and standard deviations, medians and interquartile ranges, and counts and percentages, as appropriate.
The secondary variable will be the proportion of children with cough resolution at day 10. The primary reported analysis will be a two-sided difference in proportions between groups. Alongside this, a sensitivity analysis will be carried out using logistic regression, where covariate adjustments will be made for the stratification variable (age > or < 6 years) and other potential confounders or variables showing baseline imbalance, which may include sex, ethnicity, clinical history of respiratory complications, presence of airway malacia. Here, we will report the adjusted odds ratio (with 95% confidence interval) for cough resolution in the treatment group relative to the control group.
Secondary outcome measures:
1. The time to next exacerbation will likely be evaluated using linear regression. Here, we will report the adjusted difference in means (with 95% confidence interval) between groups. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.
2. The difference in PC-QoL scores for children from day-1 to day-10 and day-1 to day-28 will be summarised by their mean and standard error. The difference in PC-QoL scores between the treatment and control groups, at day-10 and day-28 separately, will be compared using an ANCOVA framework. That is, the day-10 and day-28 scores (separately) will be the outcome variable, with the day-1 scores will be included as an adjustment variable. The minimum important difference in scores is 0.918, with the higher score representing a better cough-related quality of life. Here, we will report the adjusted mean difference (with 95% confidence interval) in PC-QoL between groups. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.
3. The time to next exacerbation will be evaluated will likely be analysis using Tobit regression, as it is expected this will be a censored outcome with some patients not experiencing an exacerbation. Here, we will report the coefficient for the group variable (with 95% confidence interval), which is used to understand the direction, magnitude, and significance of the difference between groups while accounting for the censored nature of the data. The covariate adjustments listed for the primary outcome may also be incorporated into this analysis.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/08/2025
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Actual
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Date of last participant enrolment
Anticipated
30/08/2028
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Actual
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Date of last data collection
Anticipated
30/08/2029
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Actual
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
28008
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Perth Children's Hospital - Nedlands
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Recruitment postcode(s) [1]
44211
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6009 - Nedlands
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Western Australian Department of Health
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Address [1]
319155
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Country [1]
319155
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
The. Kids Research Institute Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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The Child and Adolescent Health Service (Western Australia)
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Address [1]
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Country [1]
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
317737
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04/06/2025
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Approval date [1]
317737
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Ethics approval number [1]
317737
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Summary
Brief summary
In children, protracted bacterial bronchitis (PBB) and chronic suppurative lung disease (CSLD) represent chronic respiratory diseases on an overlapping continuum that can progress to irreversible bronchiectasis. Early management, principally through appropriate antibiotic treatment can prevent progression of disease in many children. Airway clearance techniques, prescribed by a physiotherapist are used routinely in children with chronic respiratory disease, such as cystic fibrosis and bronchiectasis to aid in sputum removal and have been shown to improve health outcomes and mortality. Increasingly, these techniques are being used in children with PBB/CSLD. However, there is no current evidence that addition of airway clearance techniques is efficacious in this cohort. Therefore, the aim of this study is to determine if airway clearance, as an adjunct to antibiotic therapy is efficacious in children with PBB. That is, does the addition of airway clearance to standard care reduce the length of the exacerbation? Our study is a single site randomised controlled, parallel clinical trial. Participants will be randomised to standard care (antibiotic therapy) or standardised care plus airway clearance during exacerbations and for 1-week post cough resolution. The primary outcome will be the proportion of children with cough resolution by day-10. Secondary outcomes will be change in (measured via parent-proxy cough-related Quality of Life) PC-QoL scores from day 1 to day-10 and 28 (post commencement of antibiotic therapy), and time to next exacerbation. We hypothesise that addition of airway clearance will result in a greater proportion of children with cough-resolution at day-10, improved PC-QoL, and longer time to next exacerbation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Pamela Laird
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Address
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The Kids Research Instutute Australia, 15 Hospital Ave Nedlands Western Australia 6009
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Country
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Australia
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Phone
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+61 410314437
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Pamela Laird
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Address
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The Kids Research Instutute Australia, 15 Hospital Ave Nedlands, Western Australia 6009
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Country
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Australia
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Phone
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+61 410314437
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Pamela Laird
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Address
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The Kids Research Instutute Australia, 15 Hospital Ave Nedlands, Western Australia 6009
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Country
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Australia
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Phone
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+61 410314437
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Fax
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Email
141988
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Not allowed under local ethics rules.
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.
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