Contact information
Type
Scientific
Primary contact
Prof Tina Lavender
ORCID ID
Contact details
University of Manchester
Jean McFarlane Building
University Place
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 306 7744
tina.lavender@manchester.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LWH0784
Study information
Scientific title
Baby Skin Care Research Programme: a randomised, assessor-blinded controlled trial comparing an infant skin-cleansing product with water
Acronym
Study hypothesis
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
Cheshire Research Ethics Committee, approved on 02/03/2009 (ref: 09/H1017/3)
Study design
Randomised assessor-blind single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
09/03/2009
Overall trial end date
01/09/2010
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
280 (added 12/01/10)
Participant 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
Recruitment start date
09/03/2009
Recruitment end date
01/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Manchester
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
Liverpool Women's NHS Foundation Trust (UK)
Sponsor details
c/o Ms Gillian Vernon
Crown Street
Liverpool
L8 7SS
United Kingdom
+44 (0)151 702 4346
gillian.vernon@lwh.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Industry
Funder name
Johnson & Johnson (USA)
Alternative name(s)
Johnson & Johnson, JNJ
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21569487
Publication citations
-
Results
Lavender T, Bedwell C, O'Brien E, Cork MJ, Turner M, Hart A, Infant skin-cleansing product versus water: a pilot randomized, assessor-blinded controlled trial., BMC Pediatr, 2011, 11, 35, doi: 10.1186/1471-2431-11-35.