Atopic eczema/atopic dermatitis Skin and Connective Tissue Diseases Atopic dermatitis
Conditions
Interventions
Babies will be randomised to have their napkin area cleansed with the baby wipe or water and cotton wool. All participating mothers will be given a demonstration by a Health Care assistant or midwife
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants with a pregnancy gestational age of 37 weeks and above, either sex 2. Using disposable nappies 3. Within the first 48 hours of birth
Exclusion criteria
Exclusion criteria: 1. Admission to the neonatal unit 2. Phototherapy 3. Limb defects 4. Non-traumatic impairment of epidermal integrity, evidence of skin disorder at first visit - for the purposes of this study the following normal variations will not be considered skin disorders - erythema neonatorum/erythema toxicum 5. Milia 6. Women known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis 7. Women known to be having their baby adopted 8. Currently participating in another clinical trial 9. Maternal age less than 16 years 10. Women who are unable to communicate through learning difficulties will not be eligible to consent for their baby
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in measurements of hydration (buttocks and thigh). Skin hydration will be measured via conductance measurements using a skin surface hydrometer. A Corneometer® which is a well established method to determine reproducibly and accurately measure the hydration level of the skin surface, will be used. The measurements are non-invasive, using test sites on the baby's skin. Measurements will be made twice at each of two sites; measurements will be taken on the buttocks and thigh. A baseline assessment will be made prior to maternal transfer into the community. A second assessment will be made at 4 weeks post-birth. The second measurement will be taken in the home. The exact locations where measurements are performed will be similar on all babies. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at one day and 4 weeks: 1. Change in erythema measurements: instrumental assessment of skin erythema will be quantified via levels of oxyhaemoglobin in skin as measured by diffuse reflectance spectroscopy 2. Acceptability of intervention: women's views on smell, perception of cleanliness, perception of skin's moisture. This will be assessed using a structured questionnaire completed by the mother at both assessment and a diary completed from randomisation to 4 weeks post-natal. At 8 weeks post-natal, women will be invited to participate in a semi-structured telephone interview, to assess their views of their allocated cleansing routine, to determine their cleansing practice and record mother's perceptions of skin condition. 3. Nappy cream usage 4. Napkin dermatitis assessed at 4 weeks postnatal, by the midwife. We will use a Diaper Area Rash grading scale. The assessment will be made by the same research midwife to ensure data reliability. A set of reference photographs depicting the various levels of diaper rash will be used by the research midwives to ensure consistency in clinical assessment. 5. Rate of change in transepidermal water loss (TEWL) defined as the flux of condensed water diffusing through the skin 6. Change in skin surface pH (buttocks and thigh). Presence of skin contaminants and irritants on the peri-anal area (Coliform Bacteria and Candida species). | — |
Countries
United Kingdom
Outcome results
None listed