Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12614001193662 |
Date of registration:
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13/11/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Investigating the association between timing of routine childhood vaccinations and food allergy
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Scientific title:
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In 1 year old children, is there an association between early versus delayed routine childhood immunisations and subsequent challenge proven food allergy at 1 year of age? |
Date of first enrolment:
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31/10/2014 |
Target sample size:
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4858 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12614001193662.aspx |
Study type:
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Observational |
Study design:
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Purpose: Natural history;Duration: Cross-sectional;Selection: Defined population;Timing: Retrospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Contacts
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Name:
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Dr Nicholas Kiraly
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Address:
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Gastro and Food Allergy
Murdoch Childrens Research Institute
Royal Children's Hospital
50 Flemington Rd Parkville VIC 3052
Australia |
Telephone:
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+61393455522 |
Email:
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nicholas.kiraly@mcri.edu.au |
Affiliation:
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Name:
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Dr Nicholas Kiraly
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Address:
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Gastro and Food Allergy
Murdoch Childrens Research Institute
Royal Children's Hospital
50 Flemington Rd Parkville VIC 3052
Australia |
Telephone:
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+61393455522 |
Email:
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nicholas.kiraly@mcri.edu.au |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Previously enrolled in the HealthNuts cohort, a large population based study of childhood food allergy in Melbourne, Australia. Briefly, healthy one-year old children were recruited at immunisation contacts and invited to participate.
Exclusion criteria: Refused consent to access Australian Childhood Immunisation Register data
Age minimum:
1 Years
Age maximum:
1 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Public Health - Epidemiology
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Food allergy;Atopic sensitisation; Food allergy Atopic sensitisation
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Inflammatory and Immune System - Allergies
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Intervention(s)
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Timing of immunisations delivered at routine immunisation contacts. Data is being collected from the Australian Childhood Immunisation Register which record all childhood vaccination contacts. Date of all childhood immunisations received in the first 18 months of life will be obtained from this register.
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Primary Outcome(s)
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Challenge proven food allergy. Children in the HealthNuts cohort were enrolled at immunisation contacts at 1 year of age and invited to undergo skin prick testing. Those with a positive skin prick test were invited to undergo oral food challenge. Hence children who were sensitised to a particular allergen were tested with the gold standard oral food challenge soon after turning one year of age. A description of the formal food challenges and assessment of outcomes has been described (Osbourne et al. 2010 Clinical & Experimental Allergy, 40, 1516–1522)[At 1 year of age]
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Atopic sensitisation defined as a positive skin prick test to any food allergen at the time of enrolment into the HealthNuts cohort (skin prick testing protocol described in Osbourne et al. 2010 Clinical & Experimental Allergy, 40, 1516–1522)[At 1 year of age]
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Secondary Outcome(s)
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Wheeze: parent reported wheeze in the first year of life[At 1 year of age]
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Eczema, defined as parental report of eczema diagnosis requiring treatment in the first year of life or eczematous rash observed by nurse at the time of recruitment into the HealthNuts cohort[At 1 year of age]
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Use of eczema medication, assessed by parental report at the time of recruitment into the HealthNuts cohort[At 1 year of age]
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Bronchiolitis admissions: parent reported admissions to hospital with bronchiolitis in the first year of life[before 1 year of age]
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
Human Research Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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