Baby Skin Care Trial: a study comparing an infant skin-cleansing product with water
| ISRCTN | ISRCTN72285670 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72285670 |
| Protocol serial number | LWH0784 |
| Sponsor | Liverpool Women's NHS Foundation Trust (UK) |
| Funder | Johnson & Johnson (USA) |
- Submission date
- 17/03/2009
- Registration date
- 26/05/2009
- Last edited
- 21/12/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
University of Manchester
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 306 7744 |
|---|---|
| tina.lavender@manchester.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised assessor-blind single-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Baby Skin Care Research Programme: a randomised, assessor-blinded controlled trial comparing an infant skin-cleansing product with water |
| Study objectives | Ammended 12/01/10: Bathing healthy term babies using a baby wash product in the first 2 weeks following birth is not inferior to bathing babies using water alone. Initial information at time of registration: Infant skin cleansing with a product is superior to bathing with water only. Please note that as of 12/01/10 this record has been updated. All updates can be found in the relevant field with the above update date. Please also note that the anticipated end date of this trial has been extended from 01/03/10 to 01/09/10, and that all outcomes will now be measured at 2 and 4 weeks, not 4 and 8. |
| Ethics approval(s) | Cheshire Research Ethics Committee, approved on 02/03/2009 (ref: 09/H1017/3) |
| Health condition(s) or problem(s) studied | Atopic eczema/ atopic dermatitis |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(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. |
| Key secondary outcome measure(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 |
| Completion date | 01/09/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 280 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 09/03/2009 |
| Date of final enrolment | 01/09/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
M13 9PL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/05/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
