Please select the eligibility criteria that correspond to the clinical trial below.
Title: THE PEBBLES STUDY: A Randomised Controlled Trial to Prevent Eczema, Food Allergy and Sensitisation Using a Skin Barrier Improvement Strategy
Brief Summary: 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.


Options:
A: The study enrolls Mother-child pairs in two steps; first mother, thereafter her new-born baby.

Inclusion Criteria:

1. Ante-natal inclusion, step 1: All mothers to-be at 18 weeks ultrasound investigation with sufficient language skills (Norwegian or Swedish), gestational age: at least 16-22 weeks.

1. Exclusion: Plans to move further than reasonable travel distance from any of the participating hospitals within the first year of the offspring's life.

1. Inclusion of the child, step 2: Live-born babies of gestational age 35.0 weeks or more (including multiple pregnancies), maternal/parental willingness to participate in the study

Exclusion Criteria:

Exclusion criteria child: 1) severe neonatal cardiac, pulmonary, neurologic, dermatologic disease or other disease that may influence the outcomes 2), plans to move further than reasonable travel distance away from any of the participating hospitals within the first nine months of life.

3) Non-willingness to participate, 4) More than two foetuses
B: 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
C: Inclusion Criteria:

* Able to consume solid food
* Allergy to eggs and/or severe eczema
* Informed consent obtained from parent or guardian.

Exclusion Criteria:

* Clinically significant chronic illness. Participants with eczema or recurrent wheeze are not excluded.
* Positive skin prick test for peanut allergen with a wheel diameter greater than 4 mm in the presence of a negative saline control
* Previous or current consumption of peanut protein that exceeds 0.2 g of peanut protein on at least one occasion or 0.5 g over a single week
* Investigator-suspected allergy to peanut protein
* Investigator-suspected allergy to peanut protein in care provider or current household member.
* Diagnosis of persistent asthma
* ALT (SGPT) or bilirubin greater than 2 times the upper limit of age-related normal value
* BUN or creatinine greater than 1.25 times the upper limit of age-related normal value
* Platelet count less than 100,000/mL, hemoglobin less than 9 g/dL, or investigator-suspected immunocompromise
* Unwillingness or inability to comply with study requirements and procedures
D: Inclusion Criteria:

1. Any preterm neonates (\>26 weeks and \< 37 weeks of gestation by maternal dates)
2. Birth weight of at least 750 gm
3. Age ≤72 hours of life
4. Baseline blood cultures obtained
5. Expected survival \> 48 hours (based on the clinical judgment by the physicians)

Exclusion Criteria:

1. Neonate with severe RDS on admission as declared by the consulting Physician on the basis of radiologic findings.
2. Neonate within first 24 hours of critical care
3. Life threatening congenital anomalies
4. Congenital skin anomalies
5. Hydrops Fetalis
6. Congenital infection of the skin
7. History of any previous treatment with the ointment
8. Newborns admitted for major surgical procedure with expected high rates of infectious complications.
9. Newborns with positive baseline blood cultures

Answer: B