Condition category
Skin and Connective Tissue Diseases
Date applied
17/03/2009
Date assigned
26/05/2009
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lwh.me.uk/

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

  1. 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.

Additional files

Editorial Notes