Prevention of eczema Skin and Connective Tissue Diseases Other dermatitis
Conditions
Interventions
UK site:
The intervention group will apply emollient to the infants entire skin surface once a day (except the scalp which is optional) especially after bathing. Parents will choose fr
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: UK and USA: 1. Infants with a family history of eczema, asthma or allergic rhinitis 2. Infant in overall good health 3. Mother aged between 16 and 45 years at delivery and capable of giving informed consent
Exclusion criteria
Exclusion criteria: UK and USA: 1. Preterm birth (defined as birth prior to 37 weeks gestation) 2. Major congenital anomaly 3. Hydrops fetalis 4. Significant dermatitis at birth not including seborrheic dermatitis (?cradle cap?) (added 13/07/2010) 5. Any severe genetic skin disorder or immunodeficiency 6. Any other serious condition that would make the use of emollients inadvisable 7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess 8. Taken supplements containing Lactobacillus Rhamnosus during pregnancy or plan to take whilst lactating (added 13/07/2010)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of families willing to be randomised. This is the most critical component of the success of any future trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of families eligible for the trial 2. Proportion of families accepting the initial invitation to participate 3. Proportion of families who found the interventions acceptable 4. Reported adherence with intervention 5. Proportion of families for whom the blinding of the assessor to the allocation status was not compromised 6. Amount of contamination as a result of increased awareness in the control group 7. Percentage of missing data and early withdrawal rates 8. Incidence of emollient-related adverse events 9. Incidence of eczema at 6 months 10. Age at onset of eczema and the proportion which are transient cases 11. Filaggrin mutation status | — |
Countries
United Kingdom, United States of America
Outcome results
None listed