Please select the eligibility criteria that correspond to the clinical trial below.
Title: An Outcome Assessor-blinded Pilot Randomised Controlled Trial of an Ion-exchange Water Softener for the Prevention of Atopic Eczema in Neonates, With an Embedded Mechanistic Study
Brief Summary: An outcome assessor-blinded pilot randomised controlled trial of an ion-exchange water softener for the prevention of atopic eczema in neonates, with an embedded mechanistic study


Options:
A: Inclusion Criteria:

* Signed informed consent, or children whose parent(s) or guardian(s) have given their written informed consent for their child's participation in the study
* Child specific written informed consent, if over 7 years of age
* Subjects with a general good and stable health condition
* Subjects with clinically stable medical conditions
* Accept to abstain from sunbathing and solarium during the study
* Overall Dry Skin score (ODS) of 1 to 2 at arms and lower legs
* TEWL \> 12 g/m2/h on the left mid volar forearm

Exclusion Criteria:

* Any dermatological condition or skin affection which may interfere with the study assessments, e.g. scars
* Suffering from porphyria
* Suffering from severe photodermatoses according to the judgment of the investigator
* Clinically significant, possibly unstable medical conditions such as metastatic tumor
* Currently having other malignant or benign tumors of the skin in the investigational area
* Any other acute or chronic pathology that may interfere with the study conduct in the investigator's opinion
* Known allergy or intolerance to any ingredients of the study product, e.g. propylene glycol
* Use of (medical) oil-containing bath additives or other oil-containing cleansers
* Current topical or systemic treatment affecting the skin, e.g. diuretics
* Treatment of dry and/or inflammatory skin conditions with topical corticosteroids during the 4 weeks before inclusion
* Systemic immunosuppressive or immunomodulatory therapy
* Topical retinoids applied during the 6 weeks before inclusion
* Topical application of immunosuppressive treatment during the 6 weeks before inclusion
* Therapeutic UV-Radiation during the 6 weeks before inclusion
* Increased UV-exposure during the 6 weeks before inclusion
B: Inclusion Criteria:

* Participant (i.e. the neonate) must have a parent or sibling with a history of doctor-diagnosed atopy (i.e. at least one of: eczema, asthma, hayfever)
* Mother aged ≥18 years of age at enrolment
* Baby \<36 weeks gestation at screening
* Informed consent from the mother on behalf of the participant
* Mother has the ability to understand English
* Live in a hard water area (\>250 mg/L Calcium Carbonate)
* Consent of landlord for installation on water softener (if appropriate)
* Occupy a property appropriate for installation of a water softener

Exclusion Criteria:

* Preterm birth (defined as birth prior to 37 weeks gestation)
* Significant inflammatory skin disease at birth not including seborrheic dermatitis ("cradle cap")
* Sibling (including twin) previously randomised to this trial. If multiple birth, the first child will be randomised into the trial.
* The child is to be fostered/adopted
* Any immunodeficiency disorder or severe genetic skin disorder
* Child has any other serious health issue which, at parent or investigator discretion, would make it difficult for the family to take part in the trial.
* Planned stays away from home for a continuous period of more than 2 weeks or a total of 1 month out of the 6 month follow up period
* Water softening or filtration device already installed
* Concurrent enrolment in any other skin-related intervention study
* Other medical condition that in the opinion of the CI could interfere with the conduct of the trial
C: Inclusion Criteria:

All preterm babies born at the study center with birth weight \< 1500g were eligible for inclusion in the study.

Exclusion Criteria:

1. Babies with birth weight less than 750 gms at birth
2. Babies with major congenital malformations.
3. Babies with severe asphyxia, hydrops and shock.
4. Babies with congenital diseases of skin associated with skin breach or denudation of skin precluding oil application
5. Babies with preexisting skin infection such as multiple furuncles (2 or more skin areas - each limb, head, chest, abdomen and back are the individual areas that will be taken as one area)
D: 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

Answer: B