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Clinical Trial Details for The PEBBLES Study - Testing a Strategy for Preventing Eczema and Food Allergy in High Risk Infants


University of Melbourne
NCT ID: NCT03667651
Last Updated: September 30, 2018

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 3
  • Gender: All
  • Age: N/A - 3 Weeks
  • Condition:
    • Eczema
    • Asthma
    • Allergy;Food
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: University of Melbourne
  • Location: Not Provided

Official Title

THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy

Purpose

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.

Eligibility

Ages Eligible for Study

N/A to 3 Weeks

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

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

Additional Information, Locations & Contacts

Sponsors & Collaborators

University of Melbourne

Investigators

Principal Investigator: Adrian J Lowe, Doctorate

University of Melbourne

Please refer to this study by its ClinicalTrials.gov identifier: NCT03667651

Location

Contacts

Mercy Women's Hospital

Heidelberg, Victoria 3084

Australia

Shaie O'Brien, MA

sdobrien@unimelb.edu.au

Frances Perry Private Hospital

Parkville, Victoria 3052

Australia

Shaie O'Brien, MA

sdobrien@unimelb.edu.au

Murdoch Children's Research Institute

Parkville, Victoria 3052

Australia

Royal Women's Hospital

Parkville, Victoria 3052

Australia