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| Name | Class |
|---|---|
| Assuta Ashdod Hospital | OTHER |
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Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disorder associated with a decreased ability of the skin to function as an efficient immunological barrier. The disease is now two to three times more prevalent in children than it was just four decades ago. It is manifested by eczematous skin lesions associated with severe itch, leading to a significant impairment in quality of life. Of additional importance, AD oftentimes progresses to allergic rhinitis and/or asthma, a process referred to as the "atopic march." Recent reports have indicated that daily application of moisturizing creams on neonates and infants can prevent the occurrence of AD and subsequently food allergies. This is postulated to be the outcome of restoring the barrier integrity of the skin through the daily application of moisturizer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Risk with Moisturizer | Experimental |
| |
| High-Risk without Moisturizer | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cura+ Moisturizing Cream | Other | Parents of at-risk infants in the intervention arm will be instructed to apply moisturizer to the infant's entire body once daily for six months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of AD at twelve months of age in the intervention group compared to the control | Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of AD at six months of age in the intervention group compared to the control | Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elena Fridman, MD | Assuta Ashdod Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Cumulative incidence of AD at 24 months of age in the intervention group compared to the control |
Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist |
| 24 months |
| Timing of onset of AD in the intervention group compared to the control | Evaluated using the UK refinement of the Hanifin and Rajka diagnostic criteria for atopic eczema and by parental report of a medical diagnosis of AD by the infant's pediatrician and/or dermatologist | 12 months |
| Severity of AD in the intervention group compared to the control | Assessed using the Patient-Oriented Eczema Measure (POEM) questionnaire and accompanying scoring criteria. Additionally, it will be assessed by parental report of first steroidal indication by physician. | 12 months |
| Cumulative incidence of food allergies at 12 months of age in the intervention group compared to the control | Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire. | 12 months |
| Cumulative incidence of food allergies at 24 months of age in the intervention group compared to the control | Evaluated with the 2010 U.S. Food and Drug Administration Food Safety Survey Questionnaire. | 24 months |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |