Eczema
Conditions
Brief summary
The purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. Hypothesis: Enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.
Interventions
DRUGSunflower oil
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
DRUGControl group
This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
DRUGAquaphor ointment
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
DRUGCetaphil cream
One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 6 Months
Healthy volunteers
No
Inclusion criteria
1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma 2. Infant in overall good health 3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age 4. Capable of giving informed consent
Exclusion criteria
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) 5. Any immunodeficiency disorder or severe genetic skin disorder 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of families willing to be randomized. | 6 months | Determine proportion of families willing to be randomized in order to design larger study in the future. |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of families who found the interventions acceptable | 6 months |
| Reported adherence with intervention | 6 months |
| Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised | 6 months |
| Amount of contamination as a result of increased awareness in the control group | 6 months |
| Proportion of families eligible for the trial, willing to participate | 6 months |
| Incidence of emollient-related adverse events | 6 months |
| Incidence of eczema at 6 and 12 months | 12 months |
| Age at onset of eczema | 6 months |
| Filaggrin mutation status | 6 months |
| Percentage of missing data and early withdrawal rates | 6 months |
Countries
United States
Outcome results
None listed