PILOT study - Recruitment: for a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy

Not Applicable

Completed

• Conditions: Asthma; Eczema; rhinoconjunctivitis; Respiratory - Asthma; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12614000556640
• Lead Sponsor: Medical Research Institute of New Zealand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

Exclusion Criteria

Unable to give informed consent for study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of infants where parents / guardians have indicated they would be likely to enrol them in the proposed main trial<br><br>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'. <br>Where they have indicated that they would be very unlikely or unlikely they will be given free-form space to indicate their reason why.<br>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 [February 2015]

Secondary Outcome Measures

Name	Time	Method
Proportion of infants whose mother has current asthma where parents / guardians have indicated they would be likely enrol them in the proposed main trial [February 2015];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[February 2015]