Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000937213
Ethics application status
Approved
Date submitted
29/05/2018
Date registered
4/06/2018
Date last updated
24/03/2024
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Pregnant women eating eggs and peanuts to reduce baby food allergies (PrEggNut Study).
Scientific title
Maternal diet rich in eggs and peanuts to reduce food allergies in infants: a randomised controlled trial
Secondary ID [1] 295016 0
NHMRC Project Grant ID: 1147576
Universal Trial Number (UTN)
Trial acronym
PrEggNut Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Food Allergy 308033 0
Condition category
Condition code
Inflammatory and Immune System 307083 307083 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The high egg and peanut diet group: Regular maternal consumption of at least 6 eggs and 60 peanuts per week from 22 weeks gestation during pregnancy until 4 months postnatal infant age while breastfeeding. Participating women will be able to include all forms of egg and peanut, and egg and peanut containing foods, towards their weekly target of egg and peanut ingestion. They will be provided with a conversion table showing the amount present in common egg or peanut foods, for example peanut butter, or egg in quiche, meatballs or in baked goods like cake and muffins.
Compliance: Participants will complete a four question quick (less than 5 minute) assessment of their egg and peanut intakes each month during the intervention period. This will be completed via a link sent to their mobile phone and used to assess intervention compliance. In the post-natal period, one additional question on breastfeeding status will also be collected each month along with the egg and peanut intake questions. These dietary group adherence assessments will cease at 4 months postpartum or prior if the participating woman ceases to breastfeed.
The recruitment research assistants at each site who will be providing the individual face-to-face dietary group allocation advice to participants will be trained by CIA Dr Palmer, who will observe and monitor their intervention advice on a six monthly basis throughout the trial. The recruitment research assistants will not collect any outcome assessment data.
Intervention code [1] 301348 0
Prevention
Comparator / control treatment
The standard egg and peanut diet group: Maternal consumption of no more than 3 eggs and 30 peanuts per week from 22 weeks gestation during pregnancy until 4 months postnatal infant age while breastfeeding. The standard egg and peanut diet group is designed to reflect the average usual maternal intake of eggs and peanuts. This was based on recent findings from an observational birth cohort at the Nepean Hospital in NSW (which is also one of the recruitment sites for this PrEggNut Study), where 899 postpartum women were found to eat on average 2.5 eggs and 20 peanuts per week.
Participating women will be able to include all forms of egg and peanut, and egg and peanut containing foods, towards their weekly target of egg and peanut ingestion. They will be provided with a conversion table showing the amount present in common egg or peanut foods, for example peanut butter, or egg in quiche, meatballs or in baked goods like cake and muffins.
Compliance: Participants will complete a four question quick (less than 5 minute) assessment of their egg and peanut intakes each month during the intervention period. This will be completed via a link sent to their mobile phone and used to assess intervention compliance. In the post-natal period, one additional question on breastfeeding status will also be collected each month along with the egg and peanut intake questions. These dietary group adherence assessments will cease at 4 months postpartum or prior if the participating woman ceases to breastfeed.
The recruitment research assistants at each site who will be providing the individual face-to-face dietary group allocation advice to participants will be trained by CIA Dr Palmer, who will observe and monitor their intervention advice on a six monthly basis throughout the trial. The recruitment research assistants will not collect any outcome assessment data.
Control group
Dose comparison

Outcomes
Primary outcome [1] 306047 0
Infant food challenge proven IgE-mediated egg allergy. Food challenge methodology: This is considered the gold standard test for IgE-mediated food allergy and will be carried out on all infants with a positive skin prick test (see allergic sensitisation secondary outcome below) to egg. The in hospital medically supervised challenge will follow the Australasian Society of Clinical Immunology and Allergy (ASCIA) standardised food challenge protocols for egg, with internationally standardised scoring and stopping criteria, under medical supervision.
Timepoint [1] 306047 0
When infant is 12 months of age.
Primary outcome [2] 306048 0
Infant food challenge proven IgE-mediated peanut allergy. Food challenge methodology: This is considered the gold standard test for IgE-mediated food allergy and will be carried out on all infants with a positive skin prick test (see allergic sensitisation secondary outcome below) to peanut. The in hospital medically supervised challenge will follow the ASCIA standardised food challenge protocols for peanut, with internationally standardised scoring and stopping criteria, under medical supervision.
Timepoint [2] 306048 0
When infant is 12 months of age.
Secondary outcome [1] 347433 0
Infant allergic sensitisation to egg. The participating infants will have skin prick testing, conducted by a research nurse specifically trained in this area of expertise, to determine allergen sensitisation to egg, with histamine and control solutions, in accordance with standard clinical methods Australasian Society of Clinical Immunology and Allergy (ASCIA) Skin Prick Testing for the Diagnosis of Allergic Disease. Sensitisation is defined as a positive skin prick test with mean weal diameter greater than or equal to 3mm to an allergen.
Timepoint [1] 347433 0
When infant is 12 months of age.
Secondary outcome [2] 347434 0
Infant allergic sensitisation to peanut. The participating infants will have skin prick testing, conducted by a research nurse specifically trained in this area of expertise, to determine allergen sensitisation to peanut, with histamine and control solutions, in accordance with standard clinical methods ASCIA Skin Prick Testing for the Diagnosis of Allergic Disease. Sensitisation is defined as a positive skin prick test with mean weal diameter greater than or equal to 3mm to an allergen.
Timepoint [2] 347434 0
When infant is 12 months of age.
Secondary outcome [3] 347435 0
Infant diagnosis of eczema. An infant eczema assessment will be performed by a research nurse specifically trained in this area of expertise. The eczema extent and severity will be measured using the standardised and validated SCORing Atopic Dermatitis (SCORAD) clinical tool assessment method. Use of any eczema treatments will also be recorded.
Timepoint [3] 347435 0
When infant is 4 and 12 months of age.

Eligibility
Key inclusion criteria
Women who are able to give informed consent, with a singleton pregnancy of less than 23 weeks gestation and who are planning to breastfeed for at least 4 months. Fetus to have at least two family members (mother, father or siblings) with medically diagnosed allergic disease (asthma, eczema, hay-fever or IgE mediated food allergy).
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with egg or peanut allergies (<1% of adult population) will be excluded, as they would be unable to safely follow the intervention without an allergic reaction.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The secure web-based randomisation service will allocate a unique uninformative study identification number and a group assignment according to a computer-generated randomisation schedule produced by a statistician not otherwise involved in the trial. Randomisation will be stratified by city and by first born or subsequent born child to the mother participant using randomly permuted blocks of varying sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Due to the nature of this type of dietary intervention it is not possible to blind the participants, however research staff undertaking the outcome assessments will be blinded to group allocation. We will have designated recruitment staff (research assistants) at each site who will provide the maternal dietary group allocation dietary advice and undertake any participant contact phone calls if needed during the intervention period. Different research staff members (research nurses) at each site, who are blinded to group allocation, will conduct the clinical allergy outcome measures appointments and allergy outcome measure phone calls if needed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculations: The primary outcome is the diagnosis of IgE-mediated egg and/or peanut food allergy at 12 months of age. The expected prevalence of IgE-mediated egg and/or peanut food allergy at 12 months of age in a population of infants with at least two family members with medically diagnosed allergic disease is 16%. Our previous trials investigating regular inclusion of egg in infant diets have found a reduced egg allergy risk of 25-35%. In this PrEggNut Study with an earlier intervention in pregnancy and lactation, we expect a minimum reduced effect of 30% on infant egg and peanut allergies. Such a reduction in the diagnosis of food allergy will lead to changes in food allergy prevention guidelines, as has been the case for the regular inclusion of allergenic solids in infant diet trial results. This level is also importantly meaningful to families and will be associated with significant health care savings and improved quality of life. To detect a reduction in food allergy from 16% to 11.2%, (relative reduction of 30%) with 85% power and overall two-sided alpha 0.05 (0.049 at the final analysis), and to allow for 10% loss to follow-up, we require 1068 women per group. Hence we will recruit a total of 2136 women.
Analysis plan: Analyses will be performed on an intention-to-treat basis (i.e. all randomised women analysed as randomised) according to a pre-specified statistical analysis plan. Data analysts will be blinded to group allocation. The proportion of infants with food challenge proven IgE-mediated egg and/or peanut allergy will be compared between groups using log binomial regression. Adjustment will be made for variables used to stratify the randomisation and other pre-specified baseline prognostic variables. The difference between groups will be expressed as a relative risk with a confidence interval and two-sided p-value. Statistical significance will account for the single pre-specified interim analysis using the O’Brien Fleming approach. A sensitivity per-protocol analysis of the primary outcome will also be undertaken in women that breastfeed to 4 months and adhere to the suggested intake of egg and peanut. Secondary outcomes will be analysed using log binomial regression for binary outcomes and linear regression for continuous outcomes. In planned subgroup analyses of the primary outcome, we will also test for evidence of effect modification by socioeconomic status, first born compared to subsequent born children for the mother participant, and total household egg and peanut dietary intakes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/09/2018
Actual
25/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2136
Accrual to date
2099
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
Recruitment hospital [1] 11015 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [2] 11016 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 11017 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 11018 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [5] 11019 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [6] 11020 0
St John of God Midland Public Hospital - Midland
Recruitment hospital [7] 11021 0
St John of God Hospital, Murdoch - Murdoch
Recruitment hospital [8] 11022 0
St John of God Hospital, Mt Lawtley - Mt Lawley
Recruitment hospital [9] 11023 0
Joondalup Health Campus - Joondalup
Recruitment hospital [10] 11024 0
Perth Children's Hospital - Nedlands
Recruitment hospital [11] 15185 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 22808 0
5006 - North Adelaide
Recruitment postcode(s) [2] 22809 0
5042 - Bedford Park
Recruitment postcode(s) [3] 22810 0
2747 - Kingswood
Recruitment postcode(s) [4] 22811 0
3084 - Heidelberg
Recruitment postcode(s) [5] 22812 0
6008 - Subiaco
Recruitment postcode(s) [6] 22813 0
6056 - Midland
Recruitment postcode(s) [7] 22814 0
6150 - Murdoch
Recruitment postcode(s) [8] 22815 0
6050 - Mt Lawley
Recruitment postcode(s) [9] 22816 0
6027 - Joondalup
Recruitment postcode(s) [10] 22817 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299597 0
Government body
Name [1] 299597 0
National Health and Medical Research Council
Country [1] 299597 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
15 Hospital Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 298916 0
None
Name [1] 298916 0
Address [1] 298916 0
Country [1] 298916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300497 0
Women's and Children's Hospital Network Human Research Ethics Committee
Ethics committee address [1] 300497 0
Women's and Children's Hospital
72 King William Road
North Adelaide SA 5006
Ethics committee country [1] 300497 0
Australia
Date submitted for ethics approval [1] 300497 0
26/03/2018
Approval date [1] 300497 0
04/07/2018
Ethics approval number [1] 300497 0
HREC/18/WCHN/42

Summary
Brief summary
Regular consumption of traditionally allergenic foods, like egg and peanut, in solid foods can reduce food allergies, however this is too late for some infants. This PrEggNut study will determine whether the risk of developing food allergies in infancy can be reduced by a maternal diet rich in eggs and peanuts during pregnancy and breastfeeding. The intervention period is from 22 weeks gestation in pregnancy until 4 months of breastfeeding. The infants are followed up until 12 months of age. The study design is a multi-site, randomised controlled trial. It is powered for infant egg and peanut food allergy outcomes with a sample size aim of 2136 women and their infants. The primary outcome for this study will be food challenge proven IgE-mediated egg and/or peanut allergy at 12 months of age. The key translatable message from this study will be to answer the question of whether higher maternal dietary intakes of eggs and peanuts during pregnancy and breastfeeding are needed to reduce the risk of food allergies developing in infants..
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83854 0
Dr Debra Palmer
Address 83854 0
Telethon Kids Institute
15 Hospital Ave
Nedlands WA 6009
Country 83854 0
Australia
Phone 83854 0
+61,0410851607
Fax 83854 0
Email 83854 0
debbie.palmer@telethonkids.org.au
Contact person for public queries
Name 83855 0
Dr Debra Palmer
Address 83855 0
Telethon Kids Institute
15 Hospital Ave
Nedlands WA 6009
Country 83855 0
Australia
Phone 83855 0
+61,0410851607
Fax 83855 0
Email 83855 0
debbie.palmer@telethonkids.org.au
Contact person for scientific queries
Name 83856 0
Dr Debra Palmer
Address 83856 0
Telethon Kids Institute
15 Hospital Ave
Nedlands WA 6009
Country 83856 0
Australia
Phone 83856 0
+61,0410851607
Fax 83856 0
Email 83856 0
debbie.palmer@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 6 months and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of CIs Debbie Palmer (debbie.palmer@telethonkids.org.au) and Maria Makrides (maria.makrides@sahmri.com).
Available for what types of analyses?
For IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by CIs Debbie Palmer (debbie.palmer@telethonkids.org.au) and Maria Makrides (maria.makrides@sahmri.com).
What supporting documents are/will be available?
No other documents available
Summary results
No Results