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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06273605




Registration number
NCT06273605
Ethics application status
Date submitted
1/02/2024
Date registered
22/02/2024
Date last updated
24/01/2025

Titles & IDs
Public title
The Egg Up Trial - Testing a New Treatment Pathway for Infants with Newly Diagnosed Egg Allergy
Scientific title
Is the Use of Home-based, Dietitian-led "egg Ladders" As a Treatment Pathway for Newly Diagnosed Infants with Immunoglobulin E (IgE) Mediated Egg Allergy Safe and Feasible? the ADAPT Program - Egg Up: a Prospective Clinical Trial
Secondary ID [1] 0 0
102828
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Egg Ladder

Other: Egg Ladder - An egg ladder is a form of home-based dietary advancement therapy that aims to facilitate the development of natural tolerance through the gradual introduction of egg containing foods with increasing quantity and allergenicity through different cooking processes. This intervention involves 5 steps over a 12 month period 1.baked egg, 2.well-cooked egg as an ingredient, 3. well cooked whole egg, 4. lightly cooked whole egg and 5.then raw egg.


Other interventions: Egg Ladder
12 month protocol of graded and gradual egg introduction
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and severity of adverse events related to baked egg ingestion (step 1) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
Assessment method [1] 0 0
Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 1 of the egg ladder - baked egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Number and severity of adverse events related to ingestion of well cooked egg as an ingredient (step 2) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
Assessment method [2] 0 0
Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 2 of the egg ladder - well cooked egg as an ingredient) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Number and severity of adverse events related ingestion of well cooked whole egg (step 3) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
Assessment method [3] 0 0
Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 3 of the egg ladder - well cooked whole egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Number and severity of adverse events related to ingestion of lightly cooked whole egg (step 4) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
Assessment method [4] 0 0
Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 4 of the egg ladder - lightly cooked whole egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
Number and severity of adverse events related to raw egg ingestion (step 5) while following the home-based egg ladder protocol as collected via parent questionnaire and medical history.
Assessment method [5] 0 0
Number, frequency and severity of adverse events as assessed by standardized predetermined criteria, related to egg ingestion (step 5 of the egg ladder - raw egg) from diagnosis until 12 months post diagnosis collected via parent questionnaire and medical history.
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Feasibility of the home-based, egg ladder protocol to achieve egg allergy resolution 12 months from egg allergy diagnosis
Assessment method [6] 0 0
Feasibility will be determined via clinician and parent questionnaires which will measure barriers to utilizing the egg ladder as a treatment pathway for newly diagnosed egg allergy.
Timepoint [6] 0 0
12 months
Secondary outcome [1] 0 0
Change from baseline (diagnosis) in parent reported Quality of Life scores using the Food Allergy Quality of Life Questionnaire (FAQLQ-PF) to study completion (12 months from diagnosis)
Assessment method [1] 0 0
The Food Allergy Quality of Life Questionnaire (FAQLQ-PF) is used for assessing the Quality of Life of children with food allergies aged 0-12 years from their parents report. It gives a total mean score consisting of scores of 3 subscales: emotional impact, food anxiety, and social and dietary limitations. The FAQLQ-PF is scored using a 7-point Likert scales from 0 to 6 - a higher score indicates worse FAQL for the recall period.
Timepoint [1] 0 0
Baseline, 12 months
Secondary outcome [2] 0 0
Change from baseline (diagnosis) in parental anxiety scores measured using the Impairment Measure for Parental Food Allergy - Associated Anxiety and Coping Tool (IMPAACT) to study completion (12 months from diagnosis)
Assessment method [2] 0 0
The Impairment Measure for Parental Food Allergy-Associated Anxiety and Coping Tool (IMPAACT) is a validated 28-item self-report questionnaire for assessing food allergy-specific anxiety in the caregivers of children with food allergy. Items are completed on a 7-point Likert scale and summed to yield a total food allergy-specific anxiety score. Total IMPAACT scores range from 0 to 196 with the higher the score the greater the level of anxiety.
Timepoint [2] 0 0
Baseline, 12 months
Secondary outcome [3] 0 0
Heath care costs
Assessment method [3] 0 0
Total cost of allergy related healthcare during the home-based egg ladder intervention with dietitian support from baseline (diagnosis) to study completion (12 months from diagnosis) compared to the current model of care at the Royal Children's Hospital Allergy clinic.
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* infants aged greater than 4 months and less than 12 months of age diagnosed by an RCH allergist with IgE- mediated egg allergy in conjunction with a positive skin prick test (SPT) or specific immunoglobulin E (sIgE) to egg white
* has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participants behalf
Minimum age
4 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* any history of severe food induced anaphylaxis. Defined as reaction requiring 2 doses of intermuscular adrenalin
* Physician diagnosed recurrent wheeze
* Not commenced or unable to eat solid food
* prescribed beta-blocker medication

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2025
Actual
Sample size
Target
Accrual to date
Final
109
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Murdoch Children's Research Institute (MCRI) - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Vicki McWilliam, PhD
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vicki McWilliam, PhD
Address 0 0
Country 0 0
Phone 0 0
0418588953
Email 0 0
vicki.mcwilliam@rch.org.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06273605