Plain English Summary
Background and study aims
Many health professionals recommend the use of olive oil or sunflower oil to prevent or treat dry skin in full term, newborn babies. Other health professionals advise parents not to use any oil on their babys skin. There has been no research to consider which approach has any immediate or long-term effect on the way a baby's skin functions, and the advice given to parents can be conflicting. At present it is not known whether any oil is better or worse for a baby's skin than no oil. Dry skin is a normal physiological process for newborn babies, but parents want to treat it. There is also some evidence to suggest that products which are used on newborn skin may have an influence on the development of eczema (atopic dermatitis). The aim of this study is to explore what is the best way to find out whether olive oil, sunflower oil or no oil is best for a baby's skin.
Who can participate?
Babies born at or after 37 weeks of pregnancy
What does the study involve?
The babies are randomly allocated to one of three groups to use olive oil, sunflower oil or no oil for 28 days. Their skin is assessed to see if the oil causes any changes. The tests are carried out twice: once before the mother and baby leave the hospital after birth and then again after 28 days.
What are the possible benefits and risks of participating?
This study will help to develop the best way to find out which skincare treatment (olive oil, sunflower oil or no oil) is best, and will help to guide future advice for newborn baby skincare. The skin tests will not harm the baby.
Where is the study run from?
St Mary's Hospital (UK)
When is study starting and how long is it expected to run for?
Recruitment will start on 4th September 2013 and continue for up to one year.
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Mrs Alison Cooke
Mrs Alison Cooke
The use of Oil in Baby SkincaRE (OBSeRvE) trial: a pilot, assessor-blinded, randomised controlled trial to assess the impact of olive oil and sunflower oil on a term baby's skin barrier function
The regular application of sunflower oil, when compared to no oil or olive oil, improves the skin barrier function of newborn term infants.
First MREC approval date 19/07/2013, ref: 13/NW/0512
Randomised; Interventional; Design type: Process of Care
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Skin; Subtopic: Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Reproductive Health & Childbirth, Paediatrics
1. Olive oil: Women in the intervention group will be asked to apply 4 drops of defined content oil twice daily to their baby on each of three sites: left forearm, left thigh and abdomen, for 28 days.
2. Sunflower oil: Women in the intervention group will be asked to apply 4 drops of defined content oil twice daily to their baby on each of three sites: left forearm, left thigh and abdomen, for 28 days
Follow Up Length: 1 month(s)
Primary outcome measures
1. Transepidermal water loss (TEWL); timepoint(s): baseline (within 48 hours of birth), follow up (28 days old)
2. Skin barrier function (change in spectral profile of lipid lamellae)
Secondary outcome measures
1. Skin surface hydration; timepoint(s): baseline (within 48 hours of birth), follow up (28 days old)
2. Skin surface pH; timepoint(s): baseline (within 48 hours of birth), follow up (28 days old)
3. Clinical observations; timepoint(s): baseline (within 48 hours of birth), follow up (28 days old)
4. Maternal satisfaction; timepoint(s): 28 days
Overall trial start date
Overall trial end date
Participant inclusion criteria
Inclusion criteria for screening phase:
Women carrying singleton pregnancies who are booked to give birth at St Mary's Hospital, Manchester
Inclusion criteria for trial:
1. Newborn term infants (born on or after 37+0 weeks gestation) less than 48 hours old
2. In good health (determined by investigator)
Inclusion criteria for qualitative interviews:
Any parent with an infant taking part in the OBSeRvE pilot RCT who has consented to take part in the qualitative study, and is purposively selected for interview
Target Gender: Male & Female; Upper Age Limit 28 days ; Lower Age Limit 0 days
Target number of participants
Planned Sample Size: 100; UK Sample Size: 100
Participant exclusion criteria
Exclusion criteria for screening phase:
1. Women known to be carrying an infant with a chromosomal abnormality or other syndromic diagnosis
2. Women known to be having their infant placed in foster care or adopted
3. Women with multiple pregnancies
4. Maternal age of less than 16 years
Exclusion criteria for trial:
1. Maternal age of less than 16 years
2. Unable to communicate consent for their infant to take part in the trial due to learning difficulties
1. Admission to neonatal unit
3. Limb defects
4. Non-traumatic impairment of epidermal integrity defined as abnormal epidermis or dermis such as collodion baby or congenital ichthyosis
5. Any medical history that may prevent the participation in the study until study conclusion
6. Currently participating in another clinical trial
7. Evidence of active skin disease or disorder at first visit (for the purposes of this study the following normal variations will not be considered skin disorders: erythema neonatorum / erythema toxicum; milia)
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
NIHR Doctoral Research Fellowship (UK); Grant Codes: DRF-2012-05-160
Funding Body Type
Funding Body Subtype
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
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26551528