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The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports a range of clinical trials studying new and existing interventions for prevention and treatment of arthritis, musculoskeletal, and skin diseases.  Recruitment for this clinical trial complete.   Updates will be made  to this page when the study completes data analysis and results become available. Please check back often and find out how these studies have contributed to generating new knowledge about diseases and conditions within the NIAMS mission area.

Click on Main Page to learn more about actively recruiting research studies for which you or someone you know may be eligible.

Study Description

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.

ELIGIBILITY CRITERIA:

Ages Eligible for Study:           up to 2 Months (Child)

Sexes Eligible for Study:          All

Accepts Healthy Volunteers:  Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design:

Allocation: Randomized

Intervention Model: Single Group Assignment

Masking: Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose: Prevention

Study Location(s):

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

Study Website:

https://clinicaltrials.gov/ct2/show/NCT03409367?term=NCT03409367&rank=1

Last Updated: