A Randomized Control Trial of a Supervised Peanut Feeding Clinic to Increase Early Peanut Introduction

TITLE: A Randomized Control Trial of a Supervised Peanut Feeding Clinic to Increase Early Peanut Introduction A. Specific Aims/Objectives We aim to assess if a supervised peanut feeding clinic within a general pediatrics practice can increase early peanut introduction and peanut feeding frequency by caregivers in their infants. We hypothesize that parents in the intervention arm who are offered a supervised peanut feeding clinic for their child's first feeding will be feeding peanuts more regularly at home than parents in the control arm who receive only standard guidance.

B. Background and Significance

1 in 13 children are allergic to at least one food, many are allergic to two or more, with significant associated mortality, morbidity, and economic costs1. In particular, peanut allergy is the leading pediatric food allergy in the United States, affecting ~2.5% of children2. Furthermore, approximately 83% of adults with peanut allergy report childhood onset, showing that children with peanut allergies are largely not outgrowing or being cured of this allergy3. While there are several treatments either available or in trials for curing or at least managing peanut allergy, they are expensive, time intensive, and thus not widely available4. Until recently we have had no way to prevent the onset of peanut allergy.

In 2015 the LEAP study showed that early and frequent consumption of peanut products starting by age 7 months in high-risk infants was protective against the development of a peanut allergy in childhood, with an 80% reduction in peanut allergy in those in the intervention group compared to controls who followed standard feeding guidelines at the time5. Infant feeding guidelines were changed in 2017 to recommend early peanut introduction for high-risk infants. Subsequent research has shown the benefits of early peanut introduction in all infants prompting a guideline change again in 2020 to promote early peanut introductions for all infants6,7.

Despite the robust research, the theoretical ease of implementation, and the benefits to individuals and society of guideline adherence, we continue to see low buy-in from parents. A study published in Pediatrics in 2023 by Samady and colleagues8 assessed 3062 caregivers of children ages 7 months to 3.5 years in 2021 regarding their peanut introduction habits. They stratified results by those who were aware of the guidelines; and, even amongst guideline aware parents, only 31% offered peanuts prior to 7-months with another 19.7% offering peanuts between 7-8 months. Among guideline aware parents, 8.4% offered peanuts daily or almost daily and 34.5% offered peanuts a few times a week. Finally, among guideline aware parents, reasons given for why they waited until after 7 months or did not feed at all were fear of an allergic reaction, being unaware of how to feed peanuts to an infant, and a disbelief in the guidelines.