Secondary Outcomes
Difference between the 2 treatment arms in:
- The proportion of participants with persistent peanut allergy at 18
months of age. Defined as i) ongoing peanut sensitisation
> 8mm OR ii) peanut SPT 3-8mm and a reaction consistent
with IgE mediated peanut allergy since randomisation or iii) positive
formal OFC.
- The proportion and severity of reported adverse events (AE) related to
tree nut ingestion as assessed by standardised predetermined criteria,
related to tree nut ingestion from randomization to 18 months of age
collected via parent questionnaire and medical history.
- The number and frequency of tree nuts ingested, measured via parent
questionnaire.
- Mean difference from baseline to 18 months of age of quality of life
and parental anxiety scores measured via Food Allergy Quality of Life
Questionnaire (FAQLQ-PF) and the State/Trait Anxiety Inventory (STAI).
- The number of allergy related healthcare visits from randomization to
18 months of age, captured per number of hospitalisations, emergency
room visits, physician office visits and medication prescriptions.
Exploratory Objective - To explore tree nut diagnostic methods
including extract versus fresh nut SPT and new cellular and antibody
diagnostic methods that may improve tree nut allergy diagnosis in the
future.