Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT03667651
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
Healthy Volunteers:
True
Sex:
ALL
Maximum Age:
3 Weeks
Study:
NCT03667651
Study Brief:
Protocol Section:
NCT03667651