PARENT-REPORTED OUTCOMES DESIGN IN A DIGITAL EARLY ALLERGEN FEEDING STUDY WITH ECZEMATOUS AND NON-ECZEMATOUS INFANTS

Abstract

<h3>Introduction</h3> Early and consistent multi-food allergen introduction may reduce the risk of food allergies. We designed a fully digital, parent-reported outcomes-focused, at-home study (INTENT) to evaluate a complementary feeding strategy using a multi-food allergen product. <h3>Methods</h3> Infants 4-6 months of age with or without eczema are randomized 1:1 to daily, early introduction of a multi-allergen food product containing 16 common food allergens, or non-intervention control. Study product is shipped to participant homes, and consent and questionnaires including monthly diet diversity inventories and reporting on the timing of common food allergen introduction are completed within the app and participants are followed for a total of 18 months. Parents will also report on the ease of compliance and convenience using the multi-food allergen product. <h3>Results</h3> Novel online recruitment strategies, such as using parent-baby community forums, were employed successfully. We found initial cases of fraudulent registration, a potential issue in direct-to-patient trials, necessitated eligibility verification phone calls. At close of recruitment, the INTENT study had 1705 active infants with 868 infants randomized to the control arm and 837 infants randomized to the active intervention arm. The mean age of enrollment is 4.7 months (range: 3-6), with 55% male, and 32% reporting their race as non-white. 496 infants had eczema at baseline. <h3>Conclusion</h3> The INTENT study results based on parent-reported outcomes will showcase how families, including those with eczematous infants, introduce food allergens and evaluate multi-food allergen products as a potentially convenient and practical complementary feeding strategy for early food allergen introduction and inclusion.