The use of oil in baby skincare trial
| ISRCTN | ISRCTN37373893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37373893 |
| Secondary identifying numbers | 14926 |
- Submission date
- 22/08/2013
- Registration date
- 22/08/2013
- Last edited
- 16/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
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
alison.cooke@manchester.ac.uk
Contact information
Scientific
Oxford Road
Manchester
M13 9PL
United Kingdom
| alison.cooke@manchester.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | 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 |
| Study acronym | OBSeRvE |
| Study hypothesis | The regular application of sunflower oil, when compared to no oil or olive oil, improves the skin barrier function of newborn term infants. |
| Ethics approval(s) | First MREC approval date 19/07/2013, ref: 13/NW/0512 |
| Condition | 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 |
| Intervention | 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) |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 04/09/2013 |
| Overall study end date | 31/08/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | Planned Sample Size: 100; UK Sample Size: 100 |
| 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 |
| 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: Women: 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 Infants: 1. Admission to neonatal unit 2. Phototherapy 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 | 04/09/2013 |
| Recruitment end date | 31/08/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
M13 9PL
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/01/2017: Publication reference added.
