NCT03667651Active, not recruitingPhase 3
The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Source: ClinicalTrials.gov · Last updated 10 May 2023
Brief summary (registry, in English)
This is a phase III, single blind (outcome assessor is blinded), randomised controlled multicentre trial of the effect of EpiCeram emollient for improving and maintaining skin barrier function and reducing incidence of eczema and food allergy in high risk infants. A total of 760 participants with a first degree family history of allergic disease (asthma, eczema, allergic rhinitis or food allergy) will be recruited (380 each group) from maternity wards of three hospitals.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 760 (estimated)
- First submitted
- 9 Sept 2018
- Start date
- 6 Mar 2018
- Primary completion date
- 31 May 2027
- Lead sponsor
- University of Melbourne
- Diseases
- Atopic dermatitis (eczema), Asthma
- NCT number
- NCT03667651
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 760
- From 6 Mar 2018 to the primary completion date, 31 May 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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
Age in the registry: - to 3 weeks · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mercy Women's Hospital Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| Royal Women's Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Frances Perry Private Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
| Murdoch Children's Research Institute Coordinator of this site? Confirm its status | Parkville | Australia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.