Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000556640
Ethics application status
Approved
Date submitted
20/05/2014
Date registered
23/05/2014
Date last updated
3/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
PILOT study - Recruitment: for a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy
Scientific title
A pilot study to determine the likelihood of parents/guardians enrolling their infant into a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use until the age of three at which time they will be assessed for wheeze and atopy.
Secondary ID [1] 284628 0
None
Universal Trial Number (UTN)
U1111-1157-0375
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 291943 0
Eczema 291944 0
rhinoconjunctivitis 291945 0
Condition category
Condition code
Respiratory 292296 292296 0 0
Asthma
Inflammatory and Immune System 292309 292309 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Pregnant mothers attending ante-natal classes at Wellington Regional Hospital, and mothers / parents / guardians and infants either in the post-natal wards, or at the immunisation / 6-week check at their primary health care providers will be approached and given an information sheet about the proposed main RCT. After informed consent, they will be asked to fill out a questionnaire.

The questionnaire will be structured in two parts:

Part 1 – demographics of parents, the infant and family history of asthma, eczema and atopy

Part 2 – the likelihood of parents / guardians enrolling their infant into the proposed main trial of paracetamol as required for pain and fever versus ibuprofen, with an assessment of wheeze and atopy at three years of age.

In the proposed main RCT infants will be randomised to receive weight-based doses of ibuprofen up to 4 times a day or weight-based doses of paracetamol up to 4 times a day, as required for pain or fever, from the age of enrolment up until 3 years of age
Intervention code [1] 289414 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292162 0
Proportion of infants where parents / guardians have indicated they would be likely to enrol them in the proposed main trial

Parents will be asked to indicate how likely they woudl be to enrole their infant into the proposed main RCT for a period fo three years on a 5 point scale ranging from 1 'very likely' to 5 'very unlikely'.
Where they have indicated that they would be very unlikely or unlikely they will be given free-form space to indicate their reason why.
Additionally they will be asked to indicate how they would feel about the following aspects of the trial on a 4-point scale: convenience, study length, their infant's health
Timepoint [1] 292162 0
February 2015
Secondary outcome [1] 308332 0
Proportion of infants whose mother has current asthma where parents / guardians have indicated they would be likely enrol them in the proposed main trial
Timepoint [1] 308332 0
February 2015
Secondary outcome [2] 308333 0
Proportion of infants with a first degree family member (mother, father or sibling) with current asthma where parents / guardians have indicated they would be likely to enrol them in the proposed main trial
Timepoint [2] 308333 0
February 2015

Eligibility
Key inclusion criteria
1. Pregnant mothers attending ante-natal classes at Wellington Regional Hospital over a three-week period – specific dates to be arranged
2. Mothers / parents / guardians and infants on post-natal wards at Wellington Regional Hospital over a three week period – specific dates to be arranged
3. Mothers / parents / guardians and infants attending immunisation and 6-week checks at primary health care providers over a three-week period – primary health care providers and specific dates to be arranged
Minimum age
No limit
Maximum age
6 Weeks
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to give informed consent for study

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size and Study Power: As this is pilot study, results of this study will help inform sample size and power calculations of the main proposed trial

Statistical methods. Sample proportions for each of the three recruitment domains will be calculated as follows:

1. Proportion of all infants where parents / guardians have indicated they would be likely to enrol them in the proposed main trial
2. Proportion of infants whose mother has current asthma where parents / guardians have indicated they would be likely to enrol them in the proposed main trial
3. Proportion of infants with a first degree family member with current asthma where parents / guardians have indicated they would be likely to enrol them in the proposed main trial

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/11/2014
Actual
17/11/2014
Date of last participant enrolment
Anticipated
30/01/2015
Actual
30/01/2015
Date of last data collection
Anticipated
Actual
30/01/2015
Sample size
Target
150
Accrual to date
Final
215
Recruitment outside Australia
Country [1] 6061 0
New Zealand
State/province [1] 6061 0
Wellington

Funding & Sponsors
Funding source category [1] 289257 0
Charities/Societies/Foundations
Name [1] 289257 0
Medical Research Institute of New Zealand
Country [1] 289257 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] 287932 0
None
Name [1] 287932 0
Address [1] 287932 0
Country [1] 287932 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291029 0
HDEC New Zealand
Ethics committee address [1] 291029 0
Ethics committee country [1] 291029 0
New Zealand
Date submitted for ethics approval [1] 291029 0
30/05/2014
Approval date [1] 291029 0
03/07/2014
Ethics approval number [1] 291029 0

Summary
Brief summary
The worldwide prevalence of asthma has increased in the past fifty years and there are large differences in prevalence in different countries. The reasons for this are unknown. Better understanding is very important for New Zealand which has one of the highest prevalence rates of asthma and severe asthma in children and adults in the world.

There is now substantial observational evidence that paracetamol use may represent a novel risk factor both for the development of asthma and increasing its severity once established.

Initially we proposed a randomised open-label parallel group trial of whether paracetamol use, as required for fever and pain, in infants following admission to hospital for bronchiolitis, increased the risk of wheeze and atopy at age 3 compared to placebo.

Because paracetamol is so widely used by parents for children for a variety of indications it was difficult to know if parents/guardians will give consent to participate in a study with a 50% chance of randomisation to placebo.

We did a feasibility study to determine possible comparators out of ibuprofen, restricted paracetamol (administering paracetamol only if the temperature was greater than 38.5 degrees and / or if the infant was in significant discomfort as recommended by WHO), or placebo.

Of 120 infants in our feasibility study we found that Ibuprofen, restricted paracetamol and placebo were acceptable to 42 (58%), 29 (40%) and 9 (12%) parents/guardians respectively.

The feasibility raised the question of recruitment sources. We initially wanted to recruit from infants admitted with bronchiolitis. But we only enrolled 36 infants into a ‘mini-RCT’ comparing paracetamol use with restricted paracetamol use in our feaibility study. In the proposed main trial we aim to recruit 1028 participants from 3 main centres. The low recruitment rate seen in our feasibility study would mean we would require a larger number of centres and many years of recruitment to meet our target of 1028 participants. Furthermore, the findings of the study would also only be directly applicable to infants admitted with bronchiolitis and not to all infants who may receive paracetamol

Therefore we now wish to explore the possible recruitment rates of all infants, and as a subset, infants whose first degree relatives have asthma, from three possible domains:
1. At ante-natal classes
2. On the post-natal wards
3. At the 6 week immunization visit at the primary healthcare providers
Trial website
Trial related presentations / publications
Public notes
A manuscript for this trial has been submitted and is currently under review with NZMJ
Attachments [1] 55 55 0 0
/AnzctrAttachments/366369-Par-asthma protocol.pdf

Contacts
Principal investigator
Name 48534 0
Dr Irene Braithwaite
Address 48534 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 48534 0
New Zealand
Phone 48534 0
+64 4 805 0245
Fax 48534 0
Email 48534 0
[email protected]
Contact person for public queries
Name 48535 0
Dr Irene Braithwaite
Address 48535 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 48535 0
New Zealand
Phone 48535 0
+64 4 805 0245
Fax 48535 0
Email 48535 0
[email protected]
Contact person for scientific queries
Name 48536 0
Dr Irene Braithwaite
Address 48536 0
Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242
Country 48536 0
New Zealand
Phone 48536 0
+64 4 805 0245
Fax 48536 0
Email 48536 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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