Background: The differential effects of using topical oils for the prevention or treatment of baby dry skin on skin barrier function may contribute to the development of childhood atopic eczema. Prevalence of atopic eczema has increased from 5% of children aged 2 to 15 years in the 1940s, to approaching 30% more recently. This increase cannot be attributed to genetic changes. It is likely that increases stem from environmental factors, including the increased use of some inappropriately formulated commercial and natural baby skincare products. Midwives, health visitors and other maternity service health professionals, in the UK, routinely recommend the use of olive oil and sunflower oil for baby dry skin or massage, but the effect of these oils on newborn baby skin has not been studied. Aim: The aim of this research was to assess the feasibility and acceptability of testing the hypothesis that the regular application of sunflower oil, when compared to no oil or olive oil, had an effect on skin barrier function of newborn term babies. Study Design: A pilot, assessor-blinded, single centre, three-arm, randomised controlled trial, with nested qualitative component, underpinned by post-positivism. Methods: Quantitative methods were used to establish proof of concept that the use of topical oils had some effect on newborn baby skin barrier function, and to assess the feasibility of trial processes and parameters. Qualitative methods were used to explore the acceptability to parents of having a newborn baby participating in a randomised controlled trial, and trial design and procedures. The study was conducted in St. Mary’s hospital, a large teaching hospital in North West England. Data were collected between September 2013 and August 2014.The randomised controlled trial included 115 babies who were randomised to three groups: sunflower oil, olive oil and no oil, using a computer-generated varied size block randomisation with concealed allocation. Parents of babies randomised to the oil groups were blinded to which oil they were allocated. Data were collected using standardised case report forms for demographic and clinical observation data, weekly telephone questionnaires and a follow-up questionnaire, informed by previous baby skincare trials. The qualitative study encompassed semi-structured interviews, conducted within six months of birth. The sample was a subset of the trial participants, purposively sampled to incorporate a mix of treatment groups and positive and negative experiences derived from the follow-up questionnaire. Data also included two open-text questions from the follow-up questionnaire. Quantitative data were managed using IBM SPSS Statistics versions 20 and 22 and analysed descriptively. Qualitative data were managed in NVivo 10 and analysed using Framework Analysis. Results: The pilot study found that a definitive randomised controlled trial is not the optimal next step. A longitudinal observational study and further mechanistic work is recommended. Recruitment was challenging and loss to follow-up was higher than anticipated. Protocol adherence was reasonable and the study was acceptable to parents. Some statistically significant results were obtained, which must be interpreted with caution as the study was not powered to detect such a difference. These results showed that both oils may impede the development of the skin barrier function from birth; clinical importance of the results is not known. Conclusion: A longitudinal observational study is required, which maps the diagnosis of atopic eczema with environmental factors such as the use of baby skincare products from birth. Mechanistic work is also required to consider the optimal skincare formulation. As any intervention should do more good than harm, it would be wrong to support the recommendation of topical olive oil or sunflower oil for newborn baby dry skin or massage, based on the study data.
| Identifer | oai:union.ndltd.org:bl.uk/oai:ethos.bl.uk:677754 |
| Date | January 2015 |
| Creators | Cooke, Alison |
| Publisher | University of Manchester |
| Source Sets | Ethos UK |
| Detected Language | English |
| Type | Electronic Thesis or Dissertation |
| Source | https://www.research.manchester.ac.uk/portal/en/theses/a-pilot-study-to-examine-the-feasibility-and-acceptability-of-assessing-the-effect-of-topical-oils-on-term-babies-skin-barrier-function-the-observe-oil-in-baby-skincare-study(a6f715cd-f897-4d15-941d-7ae86d5e06c4).html |
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