Asthma Clinical Trial
— PEBBLESOfficial title:
THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Verified date | May 2023 |
Source | University of Melbourne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 760 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 3 Weeks |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Mercy Women's Hospital | Heidelberg | Victoria |
Australia | Frances Perry Private Hospital | Parkville | Victoria |
Australia | Murdoch Children's Research Institute | Parkville | Victoria |
Australia | Royal Women's Hospital | Parkville | Victoria |
Lead Sponsor | Collaborator |
---|---|
University of Melbourne |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Presence of eczema | as assessed using i) the UK working party criteria for eczema and/or ii) blinded investigator observed eczema. | 12 months of age. | |
Primary | Confirmed diagnosis of food allergy at 12 months (52 weeks). | This diagnosis is derived from a combination of allergic sensitisation, reaction history and food challenge. A skin prick test to six common allergens will be performed (egg white, cows' milk, peanut, dust mite, cat dander, and rye grass) along with a negative (saline) and a positive (histamine) control. Participants that are sensitised to certain foods (>=1mm wheal) during the skin prick testing will be given a challenge to determine if they are allergic to those foods. This will be conducted at the MCRI Allergy Clinic under the supervision of a Doctor specifically trained in oral food challenges. | 12 months of age | |
Secondary | Eczema severity | assessed using the EASI score | 12 months of age | |
Secondary | Parent report of a community doctor diagnosis of eczema | 12 months of age | ||
Secondary | infant skin barrier function | As assessed by Trans-epidermal water loss (Vapometer) | At 6 weeks and 12 months of age | |
Secondary | Parental compliance with a program to build infant skin barrier function | as assessed by parental completion of weekly diary cards and weighing of the tubes of study cream at each visit | At 6 weeks and 6 months of age. | |
Secondary | Adverse events | as assessed by the documentation of any untoward medical occurrence in a participant enrolled into this study | From recruitment of infant until final study visit at 12 months of age. | |
Secondary | skin microbial colonisation, or skin lipid profile | Assessed using skin swabs at baseline, 6 weeks and 12 months of age | At 6 weeks and 6 and 12 months of age |
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