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

Baby Skin Care Research Programme: a randomised, assessor-blinded controlled trial comparing an infant skin-cleansing product with water

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72285670
Enrollment
280
Registered
2009-05-26
Start date
2009-03-09
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 instr

Sponsors

Liverpool Women's NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026