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

Completed

• Conditions: Atopic eczema/ atopic dermatitis; Skin and Connective Tissue Diseases; Atopic dermatitis

• Registration Number: ISRCTN72285670
• Lead Sponsor: iverpool Women's NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 280

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>(Added 12/01/10):<br>Average of the TEWL measurements over three sites (arm, leg and abdomen) will be calculated.<br><br>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 Measures

Name	Time	Method
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 <br>2. Skin surface pH<br>3. Measurement of hydration<br>4. Change in clinical observations (erythema, dryness and scaling, need for medical products/ attention)<br><br>Follow up will take place at 2 and 4 weeks following birth. This will include assessment of all primary and secondary outcome measures.