Baby Skin Care Trial: a study comparing an infant skin-cleansing product with water

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN72285670
• Date of registration: 26/05/2009
• Prospective Registration: No
• Primary sponsor: Liverpool Women's NHS Foundation Trust (UK)
• Public title: Baby Skin Care Trial: a study comparing an infant skin-cleansing product with water
• Scientific title: Baby Skin Care Research Programme: a randomised, assessor-blinded controlled trial comparing an infant skin-cleansing product with water
• Date of first enrolment: 09/03/2009
• Target sample size: 280
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN72285670
• Study type: Interventional
• Study design: Randomised assessor-blind single-centre trial (Prevention)

Countries of recruitment

United Kingdom

Contacts

• Name: Tina Lavender

Key inclusion & exclusion criteria

Inclusion criteria: 1. Screening phase:
1.1. Women carrying singleton pregnancies who are booked to give birth at the study hospital
2. Trial phase:
2.1. Babies (both males and females) born between 37 weeks and 41 weeks
2.2. In good general health (as determined by the investigator)
Exclusion criteria: 1. Screening phase:
1.1. Women known to be carrying a baby with a chromosomal abnormality or other syndromic diagnosis
1.2. Women known to be having their baby adopted
2. Trial phase:
2.1. Admission to the neonatal unit
2.2. Phototherapy
2.3. Limb defects
2.4. 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
2.5. Milia
2.6. Maternal age <18

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 be bathed in water only or bathe with the new baby wash product. All participating mothers will be given a demonstration bath by a health care assistant who has been instructed on the appropriate advice. Women will be given written instructions to take home. The intervention will last from birth until 8 weeks of age.

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

Primary Outcome(s)

Rate of change in trans-epidermal water loss (TEWL) measurement from the first bath until day 56 after birth. TEWL is defined as the flux of condensed water diffusing through the skin.

(Added 12/01/10):
Average of the TEWL measurements over three sites (arm, leg and abdomen) will be calculated.

Follow up will take place at 2 and 4 weeks following birth. This will include assessment of all primary and secondary outcome measures.

Secondary Outcome(s)

1. Acceptability of intervention The views of mothers and significant others on smell, perception of cleanliness, perception of skin's moisture, measured using a specifically designed questionnaire and diaries which have gained content validity by being informed by the earlier qualitative work
2. Skin surface pH
3. Measurement of hydration
4. Change in clinical observations (erythema, dryness and scaling, need for medical products/ attention)

Follow up will take place at 2 and 4 weeks following birth. This will include assessment of all primary and secondary outcome measures.

Secondary ID(s)

LWH0784

Source(s) of Monetary Support

Johnson & Johnson (USA)