The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants (PEBBLES)
Eczema, Asthma, Allergy;Food
About this trial
This is an interventional prevention trial for Eczema
Eligibility Criteria
Inclusion Criteria:
Infants will be eligible for this study if their mother, father, or an older sibling has a self-reported history of at least one of the following conditions:
- asthma,
- eczema/atopic dermatitis,
- hay fever/ allergic rhinitis or
- food allergy
Exclusion Criteria: infants with any of the following will be excluded:
- A parent who has a known hypersensitivity to any of the ingredients of EpiCeram™ will be excluded, as it would be difficult for these parents to apply EpiCeram™ to their infant, and there is likely to be an increased risk of the infant reacting to the cream.
- Multiple births (twins, triplets etc.) will be excluded, due to the difficulty in randomising individual twins and because of the clustering effect of multiple children from the same family which would reduce the effective sample size of the study.
- Who are born premature (<36 weeks) as the effect of the intervention may be different in premature infants.
- Who have major birth or early life medical complications that require admission into a special care nursery, as it will be difficult for parents to comply with the study requirements.
- Whose parents do not have sufficient English language skills to be able to answer questions.
- Whose parents are not able to comply with all protocol required visits and procedures
Sites / Locations
- Mercy Women's Hospital
- Frances Perry Private Hospital
- Murdoch Children's Research Institute
- Royal Women's Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Twice daily use treatment with EpiCeram
Standard skin care
They will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for 6 months. The prophylactic use of EpiCeram™ is the intervention that is being tested for its effect on infant skin barrier function. We will instruct parents to apply approximately 6 grams of EpiCeram™ per application at two regular times each day, including after bathing the infant, or at the time they would normally bathe their child.
Parents are to follow standard skin care practices