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Trial registered on ANZCTR


Registration number
ACTRN12617001195347
Ethics application status
Approved
Date submitted
8/08/2017
Date registered
16/08/2017
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
A comparison-group intervention study of medically supervised clinics for first peanut consumption compared with standard care to evaluate rates of introduction of peanut by 12 months of age in infants at risk of peanut allergy.
Secondary ID [1] 292426 0
NA
Universal Trial Number (UTN)
Trial acronym
PIPPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peanut allergy 304022 0
Condition category
Condition code
Inflammatory and Immune System 303352 303352 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 298601 0
Behaviour
Intervention code [2] 298868 0
Prevention
Comparator / control treatment
he control group will consist of infants at 12 months of age who did not attend a PIPPA clinic to introduce peanut for the first time. These infants will be recruited from community settings such as General Practices and Community Immunisation Clinics when attending for their routine 12 month immunisation visits, or from hospital clinics when coincidentally attending for other medical appointments. Infants will be included in the control group if they have one of the identified risk factors for peanut allergy, namely eczema treated with over the counter or prescription steroids, any other food allergy, a first degree relative with nut allergy, or any 2 first degree relatives with one or more atopic disease (food allergy, hayfever, eczema and/or asthma).
Control group
Active

Outcomes
Primary outcome [1] 302797 0
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.
Timepoint [1] 302797 0
12 months of age.
Primary outcome [2] 302798 0
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).
Timepoint [2] 302798 0
12 months of age.
Secondary outcome [1] 337056 0
The number of allergic reactions to first ingestion in the PIPPA versus control group. Reactions in the PIPPA group will be determined by direct observation of study clinicians, as first ingestion of peanut in the intervention (PIPPA) group will occur in the PIPPA clinic under supervision. Reactions to first consumption of peanut at home in the control group will be assessed by telephone questionnaire at 12 months of age.
Timepoint [1] 337056 0
12 months of age
Secondary outcome [2] 337057 0
The parent reported type and severity of reactions to peanut at home in the PIPPA versus control group. This will be a composite outcome, and assessed via telephone questionnaire with participants in the intervention and control groups at 12 months of age. The questionnaire has been specifically designed for this study.
Timepoint [2] 337057 0
12 months of age
Secondary outcome [3] 337059 0
Associations between SPT results to peanut and a clinical reaction to first peanut ingestion during the PIPPA clinics.
Timepoint [3] 337059 0
4-11 months of age
Secondary outcome [4] 337060 0
Correlation between SPT results and reaction to mucosal lip rub with peanut butter during the PIPPA clinics.
Timepoint [4] 337060 0
4-11 months of age

Eligibility
Key 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)
Minimum age
4 Months
Maximum age
13 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This study is a comparison-group intervention study.

Infants between 4 and 11 months of age who meet the inclusion criteria will be recruited to the intervention arm of the study (i.e. invited to attend a PIPPA clinic for first consumption of peanut under supervision).

The control group will be randomly selected infants who are already 12 months of age, and meet the inclusion criteria for the control group (i.e. they have one of the identified risk factors for developing peanut allergy). As infants in the control group are already 12 months of age, they would not be eligible to participate in the intervention which is limited to 4-11 month old infants.
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8558 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 8559 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 8560 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 16662 0
6150 - Murdoch
Recruitment postcode(s) [2] 16663 0
6008 - Subiaco
Recruitment postcode(s) [3] 16664 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 296985 0
Government body
Name [1] 296985 0
Department of Health, Western Australia
Address [1] 296985 0
189 Royal Street, East Perth, 6004
Country [1] 296985 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Road
Subiaco WA 6008
Country
Australia
Secondary sponsor category [1] 296216 0
None
Name [1] 296216 0
Address [1] 296216 0
Country [1] 296216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298184 0
Princess Margaret Hospital for Children
Ethics committee address [1] 298184 0
Roberts Road
Subiaco WA 6008
Ethics committee country [1] 298184 0
Australia
Date submitted for ethics approval [1] 298184 0
17/01/2017
Approval date [1] 298184 0
04/05/2017
Ethics approval number [1] 298184 0
RGS0000000018

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76250 0
Dr Michael O'Sullivan
Address 76250 0
Immunology Department
Princess Margaret Hospital
Roberts Road
Subiaco WA 6008
Country 76250 0
Australia
Phone 76250 0
+61 8 9340 8310
Fax 76250 0
Email 76250 0
Michael.O'Sullivan@health.wa.gov.au
Contact person for public queries
Name 76251 0
Dr Michael O'Sullivan
Address 76251 0
Immunology Department
Princess Margaret Hospital
Roberts Road
Subiaco WA 6008
Country 76251 0
Australia
Phone 76251 0
+61 8 9340 8310
Fax 76251 0
Email 76251 0
PIPPA@health.wa.gov.au
Contact person for scientific queries
Name 76252 0
Dr Michael O'Sullivan
Address 76252 0
Immunology Department
Princess Margaret Hospital
Roberts Road
Subiaco WA 6008
Country 76252 0
Australia
Phone 76252 0
+61 8 9340 8310
Fax 76252 0
Email 76252 0
PIPPA@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
No Results