Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Skin
Conditions
Interventions
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.
Sponsors
University of Manchester (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed