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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (moisturizer group) | Active Comparator | One group will be instructed to use a choice of 3 FDA-approved moisturizers and soap substitutes on their newborn infants. |
|
| Control group (no moisturizers) | Active Comparator | This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunflower oil | Drug | One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of families willing to be randomized. | Determine proportion of families willing to be randomized in order to design larger study in the future. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of families eligible for the trial, willing to participate | 6 months | |
| Proportion of families who found the interventions acceptable | 6 months | |
| Reported adherence with intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric L. Simpson, M.D., M.C.R. | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 12, 2019 | |
| Reset | Aug 8, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 12, 2019 | Aug 8, 2019 |
| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| D000074242 | Sunflower Oil |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Control group | Drug | This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants. |
|
| Aquaphor ointment | Drug | One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. |
|
| Cetaphil cream | Drug | One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants. |
|
| 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 |
| Percentage of missing data and early withdrawal rates | 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 |
| D015340 |
| Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |