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:
- Mild - The symptom is easily tolerated by the subject, causes minimal
discomfort and does not interfere with everyday activities.
- Moderate - The symptom causes sufficient discomfort to interfere with
normal, everyday activities and may require over the counter
medications
- Severe - The symptom causes significant discomfort preventing everyday
activities and may require medical intervention.
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.