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Trial registered on ANZCTR


Registration number
ACTRN12613000309785
Ethics application status
Approved
Date submitted
8/03/2013
Date registered
20/03/2013
Date last updated
4/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Bronchiolitis / Paracetamol in infancy: a feasibility study
Scientific title
Is it feasible to undertake a multi-centre randomised control trial of paracetamol versus another anti-pyretic (or placebo) in infants aged between 6 months and 2 years who have been admitted to hospital with a clinical diagnosis of bronchiolitis, to see if there is increased risk of wheezing and atopy by age 3.
Secondary ID [1] 282089 0
Nil
Universal Trial Number (UTN)
U1111-1137-6190
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma
Although we are looking at recruit from a population of infants that have been diagnosed with bronchiolitis, this is because we know that this population has a higher risk of developing wheezing and atopy in childhood, so we believe our likely incidence of asthma by the age of three will be higher in this population than in the general population.
288592 0
Condition category
Condition code
Respiratory 288923 288923 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study undertaken in 2 parts.
Module one: questionnaire administered to all parents / guardians of infants admitted to hospital with bronchiolitis to establish their likelihood of participating in a larger longer term study AND to establish preferred comparator to paracetamol (out of placebo, ibuprofen or paracetamol only according to WHO guidelines). Module one to be completed by December 2013.
Module two: Enrollment of 50 participants in Module one into an open label 3-month trial, comparing paracetamol use 'as usual' (in accordance with manufacturers guidelines: 15-20mg /kg, up to 4 times per day, and child to see GP if still problematic after 3-4 days of treatment) with paracetamol only according to WHO guidelines (give 15mg / kg paracetamol only when child has temperature greater than 38.5 degrees AND / OR when child appears to be in significant pain, and only for the shortest period of time). Module Two to be completed by December 2013

All paracetamol is in oral syrup form.
Intervention code [1] 286694 0
Treatment: Other
Comparator / control treatment
INTERVENTION arm is paracetamol only according to WHO guidelines for infants (when child has temperature greater then 38.5 degrees AND / OR appears to be in significant pain)

CONTROL / COMPARATOR arm is paracetamol for infants as would usually be given by parents / guardians

This is a feasibility study designed to find out whether parents would enroll their infants in a future, larger study involving placebo / ibuprofen / or WHO restricted paracetamol, BUT we have no intentions of trialing either placebo or ibuprofen in THIS study. Instead Module One is a questionnaire designed to find out which possible alternative / intervention arm parents would be most comfortable with in a future hypothetical study.

Module Two is the intervention part of the study and the only two arms are paracetamol as parents would normally administer it (as previously described) and paracetamol according to WHO guidelines (also previously described).

There is no placebo in THIS study, so have left the question below as 'Active'
Control group
Active

Outcomes
Primary outcome [1] 289048 0
Module One:
a. the proportion of parents / guardians who would enroll their infant in a long term study where they would have a 50% chance of being allocated to paracetamol use as they would normally give it, or to an alternative arm consisting of restricted paracetamol use OR ibuprofen OR placebo.

Will be assessed as follows:
1. Derived from the answers given in the questionnaire in Module One


Timepoint [1] 289048 0
End of Module One - estimated December 2013
Primary outcome [2] 289049 0
Module One
b. Parental / guardian preference for comparator group (restricted paracetamol, ibuprofen or placebo)
- assessed by evaluating answers given in questionnaire to Module One
Timepoint [2] 289049 0
End of Module One - anticipated December 2013
Primary outcome [3] 289050 0
Is there a statistical difference in paracetamol dosing between the group allocated to paracetamol as usual and the groups allocated to restricted paracetamol

Assessed by capturing paracetamol usage for both groups in a study diary kept by parents over a three month period, and doing T-square test to assess if there is a statistically significant difference in the amounts used by both groups
Timepoint [3] 289050 0
End of Module Two - anticipated end December 2013
Secondary outcome [1] 301636 0
Qualitative assessment of the tools / methods used in the feasibility study
- participants in Module Two will be asked for qualitative feedback by questionnaire
Timepoint [1] 301636 0
End Module Two

Eligibility
Key inclusion criteria
Parents / guardians of all infants admitted to the pediatrics ward of Wellington Regional Hospital with a clinical diagnosis of bronchiolitis over the New Zealand Winter season of 2013
Minimum age
6 Months
Maximum age
2 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to obtain informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Module One: enrollment for questionnaire only which will only be undertaken after informed consent obtained
Module two: enrollment of infant and parent(s) / guardian(s) into study after informed consent. Statistician to generate a random allocation programme ensuring 25 participants allocated to paracetamol as usual and 25 to restricted paracetamol use. Neither participants nor researchers will know intervention arm until envelope is opened with allocation slip inside. Study is not blinded, so after envelope is opened researchers and participants will know intended study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4902 0
New Zealand
State/province [1] 4902 0
Wellington

Funding & Sponsors
Funding source category [1] 286866 0
Government body
Name [1] 286866 0
Health Research Council of New Zealand
Address [1] 286866 0
PO Box 5541
Wellesley Street
Auckland 1141
Country [1] 286866 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Level 7, CSB Building
Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
Country
New Zealand
Secondary sponsor category [1] 285658 0
None
Name [1] 285658 0
Address [1] 285658 0
Country [1] 285658 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288926 0
Health and Disability Ethics Committee
Ethics committee address [1] 288926 0
PO Box 5013
Wellington 6011
Ethics committee country [1] 288926 0
New Zealand
Date submitted for ethics approval [1] 288926 0
Approval date [1] 288926 0
28/01/2013
Ethics approval number [1] 288926 0
12/STH/53

Summary
Brief summary
We are trying to see if it is feasible to run a large multi-centre clinical trial to see whether paracetamol use in infancy compared to an alternative (either restricted paracetamol use OR ibuprofen OR placebo) increases the risk of wheezing and atopy by the age of three.
We need to find out how acceptable possible alternative to paracetamol would be to parents.
We also need to find out whether restricted paracetamol use would actually be statistically different from paracetamol use as usual if we were to offer it as an alternative treatment arm.
Trial website
Trial related presentations / publications
The trial results were published in Clinical and Experimental Allergy (CEA):
Riley J, Braithwaite I, Shirtcliffe P, Caswell-Smith R, Hunt A, Bowden V, Power S, Stanley T, Crane J, Ingham T, Weatherall M, Mitchell EA, Beasley R. Randomised controlled trial of asthma risk with acetaminophen use in infancy – a feasibility study. Clin Exp Allergy. 2014 Oct 9. Doi: 10.1111/cea.12433
Public notes

Contacts
Principal investigator
Name 38374 0
Prof Richard Beasley
Address 38374 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 38374 0
New Zealand
Phone 38374 0
+64 4 805 0147
Fax 38374 0
Email 38374 0
richard.beasley@mrinz.ac.nz
Contact person for public queries
Name 38375 0
Dr Irene Braithwaite
Address 38375 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 38375 0
New Zealand
Phone 38375 0
+64 4 805 0245
Fax 38375 0
Email 38375 0
irene.braithwaite@mrinz.ac.nz
Contact person for scientific queries
Name 38376 0
Dr Irene Braithwaite
Address 38376 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 38376 0
New Zealand
Phone 38376 0
+64 4 805 0245
Fax 38376 0
Email 38376 0
irene.braithwaite@mrinz.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary