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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12612000518864
Ethics application status
Approved
Date submitted
4/05/2012
Date registered
15/05/2012
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Date results information initially provided
16/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
OM-85 in the prevention of asthma in high-risk children
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Scientific title
A phase 3, single-centre, double-blind, randomised, placebo-controlled study testing the primary prevention of persistent asthma in high risk children by protection against acute respiratory infections during early childhood using OM-85.
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Secondary ID [1]
280436
0
Nil
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Universal Trial Number (UTN)
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Trial acronym
OMPAC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
286409
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Condition category
Condition code
Respiratory
286659
286659
0
0
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Asthma
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Inflammatory and Immune System
286727
286727
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0
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Normal development and function of the immune system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
OM-85 capsule powder (3.5mg) in five blocks of 10 days treatment plus 20 days no treatment, during the first two winter viral seasons (April to September) of a child's life. Capsule powder can be dissolved in fruit juice, water or milk for administration. Parents/guardians will be contacted toward the start of each treatment block as a reminder. Parents/guardians will be given a calendar as a reminder to start treatment blocks and to record doses given or missed. Parents/guardians will return empty and full blister packs at study visits to monitor adherence.
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Updated from
OM-85 oral liquid
3.5mg (320 microliters as 10 drops) daily for 30 days then four blocks of 10 days treatment, 20 days no treatment each winter season for the first two winters (April to September) of a child's life
Reason:
Drug formulation changed from liquid to powder
Updated on
22/07/2013 11:43:48 AM
Intervention code [1]
284795
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Prevention
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Updated from
Prevention
Reason:
not changed. field marked as incomplete
Updated on
4/02/2013 3:33:58 PM
Comparator / control treatment
Placebo comprising of excipients of neutralising agents including starch (gluten free).
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Updated from
Placebo
Comprising of excipients from active drug including water, sodiums and neutralising agents
Reason:
Drug formulation changed from liquid to powder
Updated on
22/07/2013 11:43:48 AM
Control group
Placebo
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Outcomes
Primary outcome [1]
287062
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Frequency of severe lower respiratory tract infections (sLRI) (fever +/- wheeze) over the first two winter viral seasons of the child's life
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Assessment method [1]
287062
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Timepoint [1]
287062
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Patient diary review at three years of age
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Secondary outcome [1]
297291
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The time to first severe lower respiratory tract infection (sLRI)
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Assessment method [1]
297291
0
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Timepoint [1]
297291
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Patient diary review at three years of age
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Secondary outcome [2]
297292
0
The frequency of sLRI during each winter of the study period
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Assessment method [2]
297292
0
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Timepoint [2]
297292
0
Patient diary review at three years of age
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Secondary outcome [3]
297293
0
The cumulative frequency of sLRI (fever +/- wheeze) during the first 3 years of life
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Assessment method [3]
297293
0
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Timepoint [3]
297293
0
Patient diary review at three years of age
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Secondary outcome [4]
297294
0
The proportion of children with a doctor diagnosis of asthma during the first 3 years of life
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Assessment method [4]
297294
0
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Timepoint [4]
297294
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Three years of age
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Secondary outcome [5]
297295
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The proportion of children requiring hospitalization for sLRI during the first 3 years of life
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Assessment method [5]
297295
0
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Timepoint [5]
297295
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Review of hospitalization records up to three years of age
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Secondary outcome [6]
297296
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Incidence of hospitalization/accident and Emergency department (A&E) visits for a sLRI
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Assessment method [6]
297296
0
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Timepoint [6]
297296
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Review of hospitalization records up to three years of age
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Secondary outcome [7]
297297
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Number of days hospitalized for sLRI
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Assessment method [7]
297297
0
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Timepoint [7]
297297
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Review of hospitalization records up to three years of age
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Secondary outcome [8]
297298
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Body mass index at 3 years of age
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Assessment method [8]
297298
0
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Timepoint [8]
297298
0
Three years of age
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Secondary outcome [9]
297299
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Lung function measures at 3 years of age
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Assessment method [9]
297299
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Timepoint [9]
297299
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Lung function measurements using the forced oscillation technique at three years of age
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Eligibility
Key inclusion criteria
1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis) 2. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration 3. Written informed consent signed and dated by parent/legal guardian according to local regulations
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Updated from
1. Children of either sex, aged 3-9 months old whose biological mother, father, or sibling has a history of asthma and/or atopy (defined as SPT reactivity to one or more allergen, food allergy, atopic dermatitis or allergic rhinitis)
2. Normal vaginal delivery (NVD)
3. Children whose full blood picture, serum biochemistry, and liver function test results are within the age- referenced normal range of the site clinical laboratory or have values outside the age- referenced normal range that are not considered clinically significant by the investigator
4. Participants who, in the opinion of the investigator, are able to comply with the protocol for its duration
5. Written informed consent signed and dated by parent/legal guardian according to local regulations
Reason:
Normal vaginal delivery was taken out as an inclusion criteria to increase recruitment field. This should not impact results as evidence to suggest difference in microbiota of children born to Cesarean section would affect results of the study.
Normal blood laboratory results were excluded to minimise blood draws, and after review of safety data, there is no reason to warrant safety bloods in this population.
Updated on
22/07/2013 11:43:48 AM
Minimum age
3
Months
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Maximum age
9
Months
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Children born less than 36 weeks gestation
2. Children who have been diagnosed with asthma
3. Children who have chronic pulmonary disease or other chronic disease (other than atopic dermatitis, food allergy, or chronic rhinitis) requiring therapy
4. Participation in another randomized controlled trial within the 3 months preceding inclusion in this study
5. Children who has previously received OM-85 or other immunostimulant or immunosuppressive drugs including cyclosporine
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Study design
Purpose of the study
Prevention
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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)
Participants will be identified antenatally from family history of asthma/allergies. Participants will be enrolled following birth. Participants will be randomised to a treatment using a code assigned by the treatment supplier.
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Updated from
Reason:
new request
Updated on
4/02/2013 3:33:58 PM
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking 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
Phase 3
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Updated from
Active, not recruiting
Reason:
study complete
Updated on
16/04/2019 10:45:43 AM
Updated from
Recruiting
Reason:
Recruitment completed for study but follow up continuing for enrolled participants
Updated on
15/06/2016 1:30:35 PM
Updated from
Not yet recruiting
Reason:
recruiting will be begin
Updated on
4/02/2013 3:33:58 PM
Date of first participant enrolment
Anticipated
1/02/2013
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Actual
10/04/2013
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Updated from
1/03/2013
Reason:
updated information
Updated on
4/02/2013 3:33:58 PM
Updated from
Reason:
New information - first patient enrolled
Updated on
22/07/2013 11:43:48 AM
Date of last participant enrolment
Anticipated
31/05/2016
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Actual
10/05/2016
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Updated from
Reason:
Anticipated last participant enrolment date updated
Updated on
15/06/2016 1:30:35 PM
Updated from
Reason:
Actuallast last participant enrolment date updated
Updated on
15/06/2016 1:30:35 PM
Date of last data collection
Anticipated
31/12/2018
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Actual
11/10/2018
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Updated from
Reason:
requested
Updated on
17/04/2018 12:53:45 PM
Updated from
Reason:
Actual final visit date.
Updated on
16/04/2019 10:45:43 AM
Sample size
Target
60
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Accrual to date
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Final
59
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Updated from
Reason:
Actual sample size updated
Updated on
15/06/2016 1:30:35 PM
Recruitment in Australia
Recruitment state(s)
QLD
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Updated from
<br />
Reason:
Recruitment state updated
Updated on
15/06/2016 1:30:35 PM
Funding & Sponsors
Funding source category [1]
285199
0
University
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Name [1]
285199
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Child Health Research Centre, The University of Queensland
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Updated from
Queensland Children's Medical Research Institute, The University of Queensland
Reason:
Queensland Children's Medical Research Institute has closed.
Updated on
16/04/2019 10:45:43 AM
Address [1]
285199
0
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane Queensland 4101
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Updated from
Royal Children's Hospital
Level 4, Foundation Building
Herston Road
Herston, QLD, 4029
Reason:
Hospital moved from Herston to South Brisbane - new facility
Updated on
16/04/2019 10:45:43 AM
Country [1]
285199
0
Australia
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Primary sponsor type
University
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Name
Child Health Research Centre, University of Queensland
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Updated from
Queensland Children's Medical Research Institute, The University of Queensland
Reason:
Queensland Children's Medical Research Institute has closed.
Updated on
16/04/2019 10:45:43 AM
Address
Level 7, Centre for Child Health Research
62 Graham Street
South Brisbane Queensland 4101
Query!
Updated from
Royal Children's Hospital<br />Level 4, Foundation Building<br />Herston Road<br />Herston, QLD, 4029
Reason:
Hospital moved from Herston to South Brisbane - new facility
Updated on
16/04/2019 10:45:43 AM
Country
Australia
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Secondary sponsor category [1]
284068
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None
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Name [1]
284068
0
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Address [1]
284068
0
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Country [1]
284068
0
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Ethics approval
Ethics application status
Approved
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Updated from
No
Reason:
ethics approval has been obtained
Updated on
4/02/2013 3:33:58 PM
Ethics committee name [1]
287200
0
Queensland Children's Health Services (RCH) HREC
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Updated from
Reason:
ethics approval has been obtained
Updated on
4/02/2013 3:33:58 PM
Ethics committee address [1]
287200
0
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Ethics committee country [1]
287200
0
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Date submitted for ethics approval [1]
287200
0
18/06/2012
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Approval date [1]
287200
0
14/08/2012
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Updated from
Reason:
ethics approval has been obtained
Updated on
4/02/2013 3:33:58 PM
Ethics approval number [1]
287200
0
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Summary
Brief summary
Persistent asthma is a major problem yet none of the current therapies do more than control the condition. The long-term solution is to prevent asthma from progressing to the persistent form. The major risk factors are: family history, early allergy and recurrent severe lower respiratory infections (sLRI) in the early life. We will conduct a randomized clinical trial to prevent sLRI using a novel bacterial-derived immunostimulant (OM-85) in infants at high risk of developing asthma. OM-85 works by priming the immune system so that body can respond quickly to infections. This will help reduce damage to the lungs during sLRI's and may prevent asthma from developing.
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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
Updated from
Updated on
4/02/2013 3:33:58 PM
Name
34137
0
Prof Peter Sly
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Updated from
Updated on
4/02/2013 3:33:58 PM
Address
34137
0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
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Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101
Updated on
16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road Herston, QLD, 4029
Updated on
15/06/2016 1:30:35 PM
Updated from
Updated on
4/02/2013 3:33:58 PM
Country
34137
0
Australia
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Updated from
Updated on
4/02/2013 3:33:58 PM
Phone
34137
0
+61 7 3069 7383
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Updated from
+61 7 3636 9690
Updated on
15/06/2016 1:30:35 PM
Updated from
Updated on
4/02/2013 3:33:58 PM
Fax
34137
0
+61 7 3069 7159
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Updated from
Updated on
15/06/2016 1:30:35 PM
Email
34137
0
p.sly@uq.edu.au
Query!
Updated from
Updated on
4/02/2013 3:33:58 PM
Contact person for public queries
Updated from
Mrs
Updated on
17/04/2018 12:53:45 PM
Updated from
Dr
Updated on
29/05/2014 11:08:37 AM
Updated from
Updated on
4/02/2013 3:33:58 PM
Name
17384
0
Dr Peter Sly
Query!
Updated from
Naima Islam
Updated on
16/04/2019 10:45:43 AM
Updated from
Julie Varghese
Updated on
17/04/2018 12:53:45 PM
Updated from
Catherine Gangell
Updated on
29/05/2014 11:08:37 AM
Updated from
Dr Catherine Gangell
Updated on
4/02/2013 3:33:58 PM
Address
17384
0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Query!
Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101
Updated on
16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
Updated on
15/06/2016 1:30:35 PM
Country
17384
0
Australia
Query!
Phone
17384
0
+61730697445
Query!
Updated from
+61 7 3-69 7444
Updated on
17/04/2018 12:53:45 PM
Updated from
+61 7 3636 1283
Updated on
15/06/2016 1:30:35 PM
Updated from
+61 7 3636 4074
Updated on
29/05/2014 11:08:37 AM
Fax
17384
0
+61 7 3069 7159
Query!
Updated from
+61 7 3636 5578
Updated on
15/06/2016 1:30:35 PM
Email
17384
0
p.sly@uq.edu.au
Query!
Updated from
naima.islam@uq.edu.au
Updated on
16/04/2019 10:45:43 AM
Updated from
julie.v@uq.edu.au
Updated on
17/04/2018 12:53:45 PM
Updated from
c.gangell@uq.edu.au
Updated on
29/05/2014 11:08:37 AM
Contact person for scientific queries
Updated from
Mrs
Updated on
17/04/2018 12:53:45 PM
Updated from
Dr
Updated on
29/05/2014 11:08:37 AM
Updated from
Updated on
4/02/2013 3:33:58 PM
Name
8312
0
Dr Peter Sly
Query!
Updated from
Naima Islam
Updated on
16/04/2019 10:45:43 AM
Updated from
Julie Varghese
Updated on
17/04/2018 12:53:45 PM
Updated from
Catherine Gangell
Updated on
29/05/2014 11:08:37 AM
Updated from
Dr Catherine Gangell
Updated on
4/02/2013 3:33:58 PM
Address
8312
0
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham Street, South Brisbane, QLD 4101
Query!
Updated from
Level 7, Centre for Children's Health Research, The University of Queensland, 62 Graham road, South Brisbane, QLD 4101
Updated on
16/04/2019 10:45:43 AM
Updated from
Queensland Children's Medical Research Institute
Level 4, Foundation Building
Royal Children's Hospital
Herston road
Herston, QLD, 4029
Updated on
15/06/2016 1:30:35 PM
Country
8312
0
Australia
Query!
Phone
8312
0
+61730697445
Query!
Updated from
+61 7 3069 7444
Updated on
17/04/2018 12:53:45 PM
Updated from
+61 7 3636 1283
Updated on
15/06/2016 1:30:35 PM
Updated from
+61 7 3636 4074
Updated on
29/05/2014 11:08:37 AM
Fax
8312
0
+61 7 3069 7159
Query!
Updated from
+61 7 3636 5578
Updated on
15/06/2016 1:30:35 PM
Email
8312
0
p.sly@uq.edu.au
Query!
Updated from
naima.islam@uq.edu.au
Updated on
16/04/2019 10:45:43 AM
Updated from
julie.v@uq.edu.au
Updated on
17/04/2018 12:53:45 PM
Updated from
c.gangell@uq.edu.au
Updated on
29/05/2014 11:08:37 AM
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
No Supporting Documents Provided
Results publications and other study-related documents
Study Result [1] (Reference No. 384)
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Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Other files
No
https://child-health-research.centre.uq.edu.au/research/research-groups/childrens-health-and-environment-program
362459-(Uploaded-15-04-2019-13-50-40)-Other results publication.pdf
History
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Last Updated
Action Performed
Other files
No
https://child-health-research.centre.uq.edu.au/research/research-groups/childrens-health-and-environment-program
362459-(Uploaded-15-04-2019-13-50-40)-Other results publication.pdf
16/04/2019
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