BaSICS (Baby skin integrity comparison survey) - Version 1
Research type
Research Study
Full title
BaSICS (Baby Skin Integrity Comparison Survey): A prospective experimental study to correlate the effect of using baby wipe products on the incidence of irritant diaper dermatitis (IDD).
IRAS ID
235164
Contact name
F.E. MacVane Phipps
Contact email
Sponsor organisation
University of Salford
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This is an experimental study to determine if any of three leading brands of baby wipe products are more or less likely to contribute to or prevent nappy rash in infants from birth to eight weeks of age. All participating infants will be supplied with the same brand of disposable nappies, but each will be randomly allocated using a computer algorithm, to one of three brands of baby wipes. These wipes (and nappies) will then be supplied throughout the 8-week data collection period. Data will be collected through daily maternal observations of her infant's skin in the nappy area (buttocks and groin), which she will score using a scale with skin descriptions numbered 1 (clear healthy skin) to 5 (severe rash). The participating mother will record her observations using either a web-based or paper survey tool (called the BEST Tool), developed and tested for the project.
The research team is interested in: how many rash-free days each baby experiences; how many days following birth any rash first appears; the severity of any nappy rash; and the length of the period for which a rash was present. Quantitative data will be analysed by the project statistician using standard quantitative data analysis tools such as SPSS (IBM's Statistical Package for the Social Sciences). Additional data on infant skin care and perceptions of the products used will be collected in one additional longer ‘final survey’ (web-based or paper-based) after the participants have completed the scores for 8 weeks. The questions in this final survey are adapted from a study undertaken by Furber et al (2012). In addition, 10% of participants will be asked to participate in an optional recorded phone or face-to-face interview on completion of their 8 week participation. This will enable further exploration of questions answered in both surveys.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
18/NE/0060
Date of REC Opinion
9 Feb 2018
REC opinion
Favourable Opinion