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Atopic dermatitis (AD) affects over 9 million children in the U.S. and often heralds the development of asthma, food allergy, skin infections, and neurodevelopmental disorders. Recent advances identify skin barrier dysfunction to be the key initiator of AD and possibly allergic sensitization.
This study hypothesizes that daily emollient use from birth can prevent the development of AD in a community setting and into newborns unselected for risk. The results of a community-based clinical trial utilizing a pragmatic trial design will be immediately applicable to the population at large and will establish a new standard of care for all newborns.
The aims of the study include:
1) Perform a pragmatic community-based randomized controlled trial investigating whether daily full- body emollient therapy starting in the first 2 months of life prevents atopic dermatitis in a real-world setting
2) As an exploratory analysis, determine whether a family history of allergic disease and key early life exposures such as pet ownership modify the preventive effect of emollient therapy on AD.
Ages Eligible for Study: up to 2 Months (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
- Parent can provide electronic signed and dated informed consent form.
- Parent is willing and able to comply with all study procedures for the duration of the study.
- Parent is a primary caretaker of an infant 0 to 2 months of age.
- Parent is 18 years of age or older at time of consent.
- Parent can speak, read, and write in English or Spanish.
- Parent has a valid e-mail address and reliable access to the internet.
- Infant is a patient of a participating Meta-LARC clinic site at the time of consent.
- Infant was born at less than 25 weeks gestational age.
- Infant has established eczema as diagnosed by the primary healthcare provider at clinic site of enrollment per parent report.
- Infant has known adverse reaction to petrolatum-based emollients.
- Infant has an immunodeficiency genetic syndrome such as Wiskott-Aldrich Syndrome or Severe Combined Immunodeficiency Syndrome.
- Infant has extremely low birth weight (less than 1000g or 2.2 lbs at birth).
- Infant has a sibling enrolled in the study.
- Parent is unwilling or unable to comply with study procedures.
Intervention Model: Single Group Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
University of Colorado-Denver, Denver, Colorado, United States, 80045
Duke University, Durham, North Carolina, United States, 27705
Oregon Health & Science University, Portland, Oregon, United States, 97239
University of Wisconsin-Madison, Madison, Wisconsin, United States, 53175