None listed
Conditions
Brief summary
Peanut allergy is the most common cause of severe food allergic reactions in children, and rates of peanut allergy appear to be rising. Some infants are at an increased risk of developing a peanut allergy due to the presence of eczema, other food allergies or a family history of allergy. For these high-risk infants, early introduction of peanut with regular consumption starting before 12 months of age significantly decreases the incidence of peanut allergy. However, parental apprehension to introduce peanut early leads to only 1 in 5 high risk infants starting peanut within the recommended window. Recent guidelines released by the Australasian Society of Clinical Immunology and Allergy suggest at risk infants should see their doctor for advice on introducing peanut, however uncertainty remains amongst health care professionals about how and where high risk infants should introduce peanut. The aim of the Promoting Introduction to Prevent Peanut Allergy (PIPPA) project is to develop a safe and efficient parent-led, clinician-supported model that promotes early introduction of peanut. This intervention study will examine the efficacy of a new model of care, where parents with high risk infants will introduce peanut in a supported environment. The primary outcome of the PIPPA project will be to compare the number of high risk infants consuming peanut before 12 months of age, between families who attend the PIPPA clinic (intervention group) and families who receive the current standard of care, and the proportion of infants who have an allergic reaction to first consumption of peanut in the PIPPA clinic. Secondary outcomes will examine whether there is any difference in the incidence of peanut allergy between the intervention and standard care group. The PIPPA project will provide evidence for the safety and efficacy of a new model of care to be implemented in a wide range of settings across Australia. The key components of the PIPPA project can be replicated in almost any healthcare environment, including primary care and rural/regional hospitals, ultimately reducing the incidence of peanut allergy in the community.
Interventions
Intervention group (PIPPA group):
Infants at increased risk of peanut allergy under 12 months of age who have not previously eaten peanut will be invited to attend a clinic for medically supervised introduction of peanut (PIPPA Clinic). Infants will consume their usual solids foods they eat at home such as pureed/mashed apple, sweet potato, yoghurt etc. 2 teaspoons of peanut butter will be added to this food and it is intended the infants will consume a maximum of 1/4 cup of food (with the pean
Intervention group (PIPPA group): Infants at increased risk of peanut allergy under 12 months of age who have not previously eaten peanut will be invited to attend a clinic for medically supervised introduction of peanut (PIPPA Clinic). Infants will consume their usual solids foods they eat at home such as pureed/mashed apple, sweet potato, yoghurt etc. 2 teaspoons of peanut butter will be added to this food and it is intended the infants will consume a maximum of 1/4 cup of food (with the peanut butter added) over a 15-30 minute time period. Prior to consuming peanut butter, a small amount of peanut butter will be rubbed on the mucosal side of the lower lip of the infant. The infant will be observed for 15 minutes to assess whether any local angioedema occurs, which would be considered to represent an allergic reaction to peanut. If there is no local angioedema of the lip, the consumption of peanut butter mixed with the infant's usual food as described above will proceed.
Sponsors
Child and Adolescent Health Service
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
4 Months to 13 Months
Healthy volunteers
No
Inclusion criteria
For the intervention group: Infants between 4 and 11 months of age who have never eaten peanut in solid foods, and are deemed as high-risk for the development of peanut allergy (classified as any one of the following): • Eczema treated with over the counter steroids or prescription medications • Allergy to a food other than peanut • Food allergy in a parent or sibling • Any atopic disease (eczema, asthma, food allergy, or allergic rhinitis/hay fever) in 2 or more first degree relatives (parents/siblings) For infants in the control group: Infants who are at least 12 months of age, have not attended a PIPPA clinic, and are deemed as high-risk for the development of peanut allergy (classified as any one of the following): • Eczema treated with over the counter steroids or prescription medications • Allergy to a food other than peanut • Food allergy in a parent or sibling • Any atopic disease (eczema, asthma, food allergy, or allergic rhinitis/hay fever) in 2 or more first degree relatives (parents/siblings)
Exclusion criteria
Infants with significant underlying medical conditions that place them at increased risk of adverse outcomes in the event of an allergic reaction, such as cardiovascular or respiratory diseases. A study doctor will review these infants before enrolling them in the study. Infants who have had previous allergy testing (skin prick or specific IgE testing) for peanut and been advised by, or in consultation with, a paediatrician or allergy specialist to avoid peanut.
Outcome results
None listed