Skip to content

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.

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.

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000466448
Enrollment
700
Registered
2007-09-14
Start date
2007-11-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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, dete

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.

Sponsors

Fred Bauer Research Fund
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
1 Days to 5 Years
Healthy volunteers
Yes

Inclusion criteria

The babies born to the mothers with past history of Asthma will be identified and enrolled for the study

Exclusion criteria

Other congenital skin disease

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026