Recruitment and Enrolment
Potential participants will be identified during standard allergy clinic
appointments and if family consent to be contacted by the study team,
the allergist will complete an electronic referral via REDCap. The
nominated contact person of potential participants will be contacted by
the study team and screened to ensure inclusion and exclusion criteria
are met. If eligible, the study team member will describe the purpose of
the study, the randomisation process, the study procedures, and the
risks and benefits of participation.
A record of all infants screened, and their enrolment status will be
maintained in a separate screening database to adhere to the
consolidated standards for the reporting of randomised controlled
trials. Deidentified data (age, sex, food allergy status, reason not
enrolled) will be kept capturing reasons for participants screened and
not enrolled. Families will consent to participate via electronic
consent module in REDCap.