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

ISRCTN	ISRCTN72285670
DOI	https://doi.org/10.1186/ISRCTN72285670
Secondary identifying numbers	LWH0784

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Tina Lavender
Scientific

University of Manchester
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 306 7744
Email	tina.lavender@manchester.ac.uk

Study information

Study design	Randomised assessor-blind single-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 measures	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.
Overall study start date	09/03/2009
Completion date	01/09/2010

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	280 (added 12/01/10)
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

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 9PL
United Kingdom

Sponsor information

Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre

c/o Ms Gillian Vernon
Crown Street
Liverpool
L8 7SS
England
United Kingdom

Phone	+44 (0)151 702 4346
Email	gillian.vernon@lwh.nhs.uk
Website	http://www.lwh.me.uk/
"ROR"	https://ror.org/04q5r0746

Funders

Funder type

Industry

Johnson & Johnson (USA)
Government organisation / For-profit companies (industry)

Alternative name(s): Johnson & Johnson, johnson & Johnson Services, Inc., Johnson&Johnson, 强生公司, Johnson & Johnson Private Limited, ジョンソン・エンド・ジョンソント, J&J, JNJ
Location: United States of America

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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