None listed
Conditions
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.
Interventions
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 pa
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.
Sponsors
Medical Research Institute of New Zealand
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Months to 2 Years
Healthy volunteers
No
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
Exclusion criteria
Unable to obtain informed consent
Outcome results
None listed