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Trial registered on ANZCTR


Registration number
ACTRN12607000466448
Ethics application status
Not yet submitted
Date submitted
11/09/2007
Date registered
14/09/2007
Date last updated
14/09/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
An intervention to reduce the prevalence and impact of asthma and food allergies occurring in association with atopic dermatitis through improved skin care in infants and young children.
Scientific title
To test our hypothesis we propose to conduct a prospective randomised controlled study. The study will investigate the impact of a number of simple intervention measures on epidermal barrier protection as measured by transepidermal water loss in infants and young children.

In addition, this randomized, controlled study will measure the prevalence and severity of atopic dermatitis.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 2360 0
Atopic Dermatitis 2361 0
Condition category
Condition code
Public Health 2465 2465 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The below intervention will be advised to the parents to follow in their babies for a period of 5 years.
Telephone contact for approximately 20 minutes will occur at weeks 1, 3, 6, 12, 26, 38, 52 and then every 6 months until the age of 5 years post-gestation.
Transepidermal water loss will be measured at 6, 12, 24 and 36 months to assess the integrity of the infants’ barrier function.
Parents will be encouraged to limit bath times to less than 5 minutes, bathe their children without soap, detergent or bubble baths and to use an emollient after bathing. In addition mothers will be given specific advice about appropriate temperatures for ducted central heating (maximum of 19 degrees Celsius), and measures to keep cool while sleeping.
The children will attend respiratory examination with spirometry and measurement of airway hyper responsiveness at age 5.
Intervention code [1] 2102 0
Prevention
Comparator / control treatment
The parents of babies in the control group will be contacted every 6 months about the condition of their babies and the status of their health will be recorded. The contacts will be every 6 months for 5 years. No advice will be given to them. Control group will receive 6 monthly telephone contacts enquiring about the development of eczema, food allergy and asthma. The children will attend a skin examination with measurement of transepidermal water loss at water loss at ages 1, 2 and 3 years.
The children will attend respiratory examination with spirometry and measurement of airway hyper responsiveness at age 5.
Control group
Active

Outcomes
Primary outcome [1] 3363 0
Incidence of asthma diagnosed by history of 3 episodes of wheeze and clinical examination
Timepoint [1] 3363 0
5 years
Primary outcome [2] 3364 0
Incidence of atopic dermatitis diagnosed by clinical examination
Timepoint [2] 3364 0
3 years
Secondary outcome [1] 5580 0
Parental report of atopic dermatitis at any time
Timepoint [1] 5580 0
4 years
Secondary outcome [2] 5581 0
Disease severity and costs associated with atopic dermatitis
Timepoint [2] 5581 0
4 years
Secondary outcome [3] 5582 0
Disease severity and costs associated with asthma
Timepoint [3] 5582 0
5 years

Eligibility
Key inclusion criteria
The babies born to the mothers with past history of Asthma will be identified and enrolled for the study
Minimum age
1 Days
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Other congenital skin disease

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)
Numbered Containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table from a statistic book
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 437 0
3065

Funding & Sponsors
Funding source category [1] 2614 0
Government body
Name [1] 2614 0
National Health and Medical Rsearch Council
Country [1] 2614 0
Australia
Primary sponsor type
Other
Name
Fred Bauer Research Fund
Address
C/o,
ANZ trustees
level 4, 100 Queen St
Melbourne Vic 3000
Country
Australia
Secondary sponsor category [1] 2363 0
None
Name [1] 2363 0
Address [1] 2363 0
Country [1] 2363 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4533 0
Ethics committee address [1] 4533 0
Ethics committee country [1] 4533 0
Date submitted for ethics approval [1] 4533 0
26/09/2007
Approval date [1] 4533 0
Ethics approval number [1] 4533 0
Ethics committee name [2] 4551 0
Ethics committee address [2] 4551 0
Ethics committee country [2] 4551 0
Date submitted for ethics approval [2] 4551 0
20/09/2007
Approval date [2] 4551 0
Ethics approval number [2] 4551 0
Ethics committee name [3] 4552 0
Ethics committee address [3] 4552 0
Ethics committee country [3] 4552 0
Date submitted for ethics approval [3] 4552 0
20/09/2007
Approval date [3] 4552 0
Ethics approval number [3] 4552 0

Summary
Brief summary
Hypothesis/research questions:
That mothers can be effectively coached on a number of simple measures that will improve skin barrier function in their infants that will reduce the incidence of Atopic Dermatitis
And that improvement in skin barrier function will reduce the incidence and severity of atopic dermatitis in the short term and ultimately, food allergy and asthma associated with atopic dermatitis
And that null mutations in the fillagrin gene increase the risk of future development of atopic dermatitis, food allergy and asthma associated with atopic dermatitis.
And that null mutations in the fillagrin gene are predictive of infants who stand to obtain the greatest benefit from interventions to improve skin barrier function.


To test our hypothesis we propose to conduct a prospective randomised controlled study. The study will investigate the impact of a number of simple intervention measures on epidermal barrier protection as measured by transepidermal water loss in infants and young children.
In addition, this randomized, controlled study will measure the prevalence and severity of atopic dermatitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28047 0
Address 28047 0
Country 28047 0
Phone 28047 0
Fax 28047 0
Email 28047 0
Contact person for public queries
Name 11204 0
Professor Rodney Sinclair
Address 11204 0
Department of Dermatology, St Vincent’s Hospital, PO Box 2900 Fitzroy, 3065
Country 11204 0
Australia
Phone 11204 0
03 92883293
Fax 11204 0
03 9288 3292
Email 11204 0
[email protected]
Contact person for scientific queries
Name 2132 0
Professor Rodney Sinclair
Address 2132 0
Department of Dermatology, St Vincent’s Hospital, PO Box 2900 Fitzroy, 3065
Country 2132 0
Australia
Phone 2132 0
03 92883293
Fax 2132 0
03 9288 3292
Email 2132 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
No additional documents have been identified.