Baby Skin Care Research Programme: Baby wipes study

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN86207019
• Date of registration: 13/05/2010
• Prospective Registration: No
• Primary sponsor: University of Manchester (UK)
• Public title: Baby Skin Care Research Programme: Baby wipes study
• Scientific title: Baby Skin Care Research Programme: Assessor-blinded randomised controlled trial comparing impregnated cleansing wipes with water in infants
• Date of first enrolment: 01/01/2010
• Target sample size: 280
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN86207019
• Study type: Interventional
• Study design: Randomised assessor-blinded controlled clinical trial (Quality of life)

Countries of recruitment

United Kingdom

Contacts

• Name: Tina Lavender

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Atopic eczema/atopic dermatitis
Skin and Connective Tissue Diseases
Atopic dermatitis

Intervention(s)

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 who has been instructed on the appropriate advice and technique. All mothers will be advised to use the same nappy, which will be supplied by the researchers for the duration of the study. This will ensure similar absorbency, a factor likely to influence skin hydration. In both groups, parents will be advised not to use any nappy creams, other than that supplied by the research team.

The babies will be stratified according to risk of atopic eczema for analysis.

The treatment duration is 4 weeks and the follow-up is another 4 weeks after that so the babies are in the study for 8 weeks in all.

Primary Outcome(s)

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 Outcome(s)

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).

Secondary ID(s)

Protocol version 9

Source(s) of Monetary Support

Johnson & Johnson (USA)