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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]

None

Universal Trial Number (UTN)

U1111-1157-0375

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Asthma

Eczema

rhinoconjunctivitis

Condition category

Condition code

Respiratory

Asthma

Inflammatory and Immune System

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

February 2015

Secondary outcome [1]

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]

February 2015

Secondary outcome [2]

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]

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]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Medical Research Institute of New Zealand

Address [1]

Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington 6021

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

HDEC New Zealand

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

30/05/2014

Approval date [1]

03/07/2014

Ethics approval number [1]

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]

/AnzctrAttachments/366369-Par-asthma protocol.pdf

Contacts

Principal investigator

Name

Dr Irene Braithwaite

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 805 0245

Fax

[email protected]

Contact person for public queries

Name

Irene Braithwaite

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 805 0245

Fax

[email protected]

Contact person for scientific queries

Name

Irene Braithwaite

Address

Medical Research Institute of New Zealand
Private Bag 7902
Wellington 6242

Country

New Zealand

Phone

+64 4 805 0245

Fax

[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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No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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