The use of oil in baby skincare trial

Not Applicable

Completed

Conditions: Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Skin
Disease: Reproductive Health & Childbirth, Paediatrics
Subtopic: Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics)
Pregnancy and Childbirth

Registration Number: ISRCTN37373893

Lead Sponsor: niversity of Manchester (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

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 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)