title: Pilot study of feasibility of a randomised controlled trial of asthma risk with paracetamol versus ibuprofen use in infancy.
abstract: OBJECTIVE
  To undertake a randomised controlled trial (RCT) of paracetamol versus ibuprofen use during infancy to determine if paracetamol is associated with an increased risk of developing asthma, the preferred method of recruitment needs to be determined. We assessed three different recruitment domains to determine the likely enrolment rates of newborn infants into a three-year or six-year RCT of paracetamol versus ibuprofen and the development of asthma symptoms. The proposed RCT would require 1,806 participants.
  
  
  METHODS
  A questionnaire was administered to a convenience sample of Auckland and Wellington based parents/guardians within three different recruitment domains: antenatal classes, postnatal wards and six-week well-child visits at primary healthcare centres.
  
  
  RESULTS
  Over a twelve-week period 19/586 (3.2%), 196/861 (22.8%), and 0/110 (0%) questionnaires were completed by parents/guardians of newborn infants in antenatal, postnatal and primary healthcare domains. In the postnatal recruitment domain, the likelihood of newborn infants being enrolled in the proposed RCT was rated 'very likely', 'likely' and 'neutral' by 15 (8%, CI 4-12%), 65 (33%, CI 26-40%) and 64 (33%, CI 25-39%) of respondents for a RCT of three years duration; and by 5 (3%, CI 1-5%), 37 (19%, CI 14-25%) and 59 (30%, CI 24-36%) of respondents respectively for a RCT of six years duration.
  
  
  CONCLUSIONS
  Postnatal wards are expected to be the most successful recruitment domain for the proposed RCT, likely a reflection of the face-to-face direct recruitment by researchers. It appears feasible to recruit into the proposed RCT using three large New Zealand tertiary hospitals.
authors.affiliation: Research Nurse, Medical Research Institute of New Zealand, Wellington.
authors.forename: Judith
authors.initials: J
authors.lastname: Riley
authors.affiliation: Research Nurse, Medical Research Institute of New Zealand, Wellington.
authors.forename: Anna
authors.initials: A
authors.lastname: Hunt
authors.affiliation: Summer Student, Medical Research Institute of New Zealand, Wellington.
authors.forename: Alice
authors.initials: A
authors.lastname: McDouall
authors.affiliation: Summer Student, The University of Auckland, Auckland.
authors.forename: Steve
authors.initials: S
authors.lastname: Waqanivavalagi
authors.affiliation: Research Fellow, Medical Research Institute of New Zealand, Wellington.
authors.forename: Irene
authors.initials: I
authors.lastname: Braithwaite
authors.affiliation: Consultant Geriatrician, Capital and Coast District Health Board, Professor of Medicine, University of Otago, Wellington.
authors.forename: Mark
authors.initials: M
authors.lastname: Weatherall
authors.affiliation: Consultant Paediatrician, Capital and Coast District Health Board, Senior Lecturer, University of Otago, Wellington.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Stanley
authors.affiliation: Director, Medical Research Institute of New Zealand, Respiratory Physician, Capital and Coast District Health Board, Wellington.
authors.forename: Richard
authors.initials: R
authors.lastname: Beasley
authors.affiliation: Professor, Paediatrics (Child and Youth Health), School of Medicine, The University of Auckland, Auckland.
authors.forename: Edwin A
authors.initials: EA
authors.lastname: Mitchell
authors.affiliation: Specialist, Liggins Institute, The University of Auckland, Paediatric Emergency Medicine Specialist, Auckland District Health Board, Auckland.
authors.forename: Stuart R
authors.initials: SR
authors.lastname: Dalziel
mesh_terms: D000082:Acetaminophen / Q000009:adverse effects*; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects*; D001249:Asthma / Q000453:epidemiology* / Q000209:etiology; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000009:adverse effects*; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D009520:New Zealand; D010290:Parents; D018579:Patient Selection; D010865:Pilot Projects; D012307:Risk Factors; D011795:Surveys and Questionnaires
chemical_list: D018712:Analgesics, Non-Narcotic; D000082:Acetaminophen; D007052:Ibuprofen