Condition category
Pregnancy and Childbirth
Date applied
22/08/2013
Date assigned
22/08/2013
Last edited
09/09/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 baby’s 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 we do not know if 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). We are conducting an initial research study 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?
Hundred babies born at or after 37 weeks of pregnancy will be recruited into the study.

What does the study involve?
The babies will be allocated randomly to one of three groups to use olive oil, sunflower oil or no oil for 28 days. We will assess their skin to see if the oil causes any changes. We will carry out the tests 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 us to develop the best way by which we can 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 that we will do will not harm the baby.

Where is the study run from?
St. Mary’s Hospital in Central Manchester, 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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Alison Cooke

ORCID ID

Contact details

Oxford Road
Manchester
M13 9PL
United Kingdom
alison.cooke@manchester.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14926

Study information

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

Acronym

OBSeRvE

Study hypothesis

The regular application of sunflower oil, when compared to no oil or olive oil, improves the skin barrier function of new born term infants.

Ethics approval

13/NW/0512; First MREC approval date 19/07/2013

Study design

Randomised; Interventional; Design type: Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

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

04/09/2013

Overall trial end date

31/08/2014

Reason abandoned

Eligibility

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 type

Patient

Age group

Neonate

Gender

Both

Target number of participants

Planned Sample Size: 100; UK Sample Size: 100

Participant exclusion criteria

Exclusion criteria for screening phase: Women known to be carrying an infant with a chromosomal abnormality or other syndromic diagnosis; women known to be having their infant placed in foster care or adopted, women with multiple pregnancies, 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

United Kingdom

Trial participating centre

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Doctoral Research Fellowship (UK); Grant Codes: DRF-2012-05-160

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes