Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000535976
Ethics application status
Approved
Date submitted
24/05/2011
Date registered
24/05/2011
Date last updated
2/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
BEAT- Beating Egg allergy trial. The effect of early introduction of egg in the diet of high risk for atopic infants and subsequent egg allergy: A prospective randomised double blind cohort study.
Scientific title
BEAT-The effect of early introduction of egg in the diet of high risk for atopic infants and subsequent egg IgE sensitisation and clinical allergy: A prospective randomised double blind cohort study.
Secondary ID [1] 262248 0
nil
Universal Trial Number (UTN)
U1111-1121-6988
Trial acronym
BEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Egg allergy 267942 0
Condition category
Condition code
Inflammatory and Immune System 268085 268085 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early blinded introduction of daily egg protein at 4-6 months of age (with first weaning food) until 8 months of age as freeze dried egg powder at 0.5g/day Diet otherwise strict avoidance of all egg until 8 months.

Control group-- Daily Placebo rice powder to be mixed with water/breast milk from 4-6 months of age until 8 months .Avoidance of egg in infants diet until 8 months- including cooked and baked egg in custards/biscuits/cakes/other foods. No other foods will be specifically avoided.
Diet normalised with no dietary restrictions from 8 months of age.
Egg powder and placebo to be continued daily (blinded from 8-12 months of age) with normalised diet.
The intervention and placebo are introduced with the first weaning food- which may be rice cereal, apple, pear (or other first food) and not prior to first food introduction. The powder can then be mixed with these foods on a daily basis. Developmental readness for solids requires that the egg powder and placebo are not introduced until the family has introduced first weaning food.
Intervention code [1] 266642 0
Treatment: Other
Comparator / control treatment
placebo- rice powder
Control group
Placebo

Outcomes
Primary outcome [1] 266824 0
IgE sensitisation as measured by skin prick testing to egg at 8 and 12 months af age.
Timepoint [1] 266824 0
8 months and 12 months of age
Secondary outcome [1] 276453 0
Clinical reactivity to egg (IgE mediated)
Timepoint [1] 276453 0
study period
Secondary outcome [2] 276454 0
IgE sensitisation to other common food allergens (peanut, wheat, soy, milk)
Timepoint [2] 276454 0
8 and 12 months of age.
Secondary outcome [3] 276455 0
Development of doctor diagnosed atopic dermatitis
Timepoint [3] 276455 0
8 and 12 months of age.
Secondary outcome [4] 276456 0
Ovalbumin and Ovomucoid specific IgG4/ IgG1,IgE

This examines markers of potential tolerance to egg protein with anticipated high IgG4. Evidence of IgE to ovalbumin rather than ovicmucoid- both egg proteins may be markers of likley egg tolerance or sensitisation.
Timepoint [4] 276456 0
12 months of age

Eligibility
Key inclusion criteria
First degree relative with atopy
<4 months of age

This is the age requirement for recruitment into the study- for the intervention to start at 4-6 months.
Infants can be recruited from birth, but not do not start intervention until they are >4 months old.
Minimum age
0 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Evidence of IgE sensitization to egg at age 4 months
Unable to complete study requirements
Twin

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)
Babies will be randomly allocated in a 1:1 ratio to "Egg" and "Rice" treatments. Treatment allocation will be stratified by gender. Allocation using permuted blocks to maintain treatment balance over time, and blocks will be a random mixture of sizes to assist allocation concealment."
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2011
Actual
20/07/2011
Date of last participant enrolment
Anticipated
Actual
5/12/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
332
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 5385 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 12837 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 267133 0
Charities/Societies/Foundations
Name [1] 267133 0
Ilhan food allergy foundation
Country [1] 267133 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital Westmead
Address
Hawkesbury Rd,
Westmead
NSW
2145
Country
Australia
Secondary sponsor category [1] 264208 0
University
Name [1] 264208 0
University of Sydney
Address [1] 264208 0
DPCH, University of Sydney
CHW Clinical School
Hawkesbury Rd,
Westmead
NSW
2145
Country [1] 264208 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267121 0
Children's Hospital Westmead Ethics committee
Ethics committee address [1] 267121 0
Ethics committee country [1] 267121 0
Australia
Date submitted for ethics approval [1] 267121 0
Approval date [1] 267121 0
13/01/2011
Ethics approval number [1] 267121 0
HREC/10/chw/4

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32654 0
Prof Dianne E Campbell
Address 32654 0
Department of Allergy and Immunology,
Hawkesbury Rd
Children's Hospital Westmead, Sydney
NSW, 2145
Australia
Country 32654 0
Australia
Phone 32654 0
61298453420
Fax 32654 0
Email 32654 0
[email protected]
Contact person for public queries
Name 15901 0
Professor Dianne Campbell
Address 15901 0
Department of Allergy and Immunology
Childrens hospital Westmead
Hawkesbury Rd,
Westmead
NSW
2145
Country 15901 0
Australia
Phone 15901 0
+6129845 1055
Fax 15901 0
+61298453389
Email 15901 0
[email protected]
Contact person for scientific queries
Name 6829 0
Professor Dianne Campbell
Address 6829 0
Department of Allergy and Immunology
Childrens hospital Westmead
Hawkesbury Rd,
Westmead
NSW
2145
Country 6829 0
Australia
Phone 6829 0
+61298453366
Fax 6829 0
+61298453389
Email 6829 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIIntroducing Allergenic Foods in Infants2016https://doi.org/10.1056/nejmc1607281
EmbaseA randomized trial of egg introduction from 4 months of age in infants at risk for egg allergy.2017https://dx.doi.org/10.1016/j.jaci.2016.08.035
N.B. These documents automatically identified may not have been verified by the study sponsor.