Adverse Events
Information on the duration, severity, frequency, outcome and relationship of adverse events (AEs) to trial intervention will be captured at visits 1-4 and from parent report between randomisation to 18 month follow up and recorded in REDCap. Severity grading for allergic reactions will be based upon the NIH NIAID Consortium for Food Allergy Research specific grading system for allergic reactions [29]. Severity grading for non-allergic reactions will be as follows:
An independent Safety Monitoring Committee consisting of three senior medical clinicians annually reviews all studies involving food allergy OFCs within our institution. For the TreEAT trial, the chair will be informed within 48 hours via email of any case of anaphylaxis due to home introduction of tree nuts or severe anaphylaxis (2 or more doses of adrenalin) during an OFC. Study monitoring will take place annually and be performed by Melbourne Children’s Trial Centre.
Ethics
Ethical approval has been granted from the Royal Children’s Hospital Human Research Ethics Committee (HREC) approval number HREC/70489.