The Promoting Introduction to Prevent Peanut Allergy (PIPPA) Project - testing a new service to support the early feeding of peanut to infants aged between 4 and 11 months at risk of allergy.

Not Applicable

Completed

• Conditions: Peanut allergy; Inflammatory and Immune System - Allergies

• Registration Number: ACTRN12617001195347
• Lead Sponsor: Child and Adolescent Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-16
• Study Completion: 2020-08-30
• Last Update Posted: 29 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of infants regularly consuming peanut at 12 months of age in the PIPPA versus control group, as assessed by telephone questionnaire at 12 months of age. Infants will be defined as regularly consuming peanut if parents report that they have been eating an average of 1 teaspoon of peanut butter (or equivalent) per week over the preceding month.<br>[12 months of age.];The proportion of infants with parent-reported peanut allergy/peanut reactions at 12 months of age in the PIPPA versus control group. Infants in both the PIPPA and control group will be contacted and will complete a telephone questionnaire to determine any parent reported adverse reactions to peanut (including the nature, severity and timing of reactions that were experienced at home). [12 months of age.]