A Community-based Assessment of Skin Care, Allergies, and Eczema
- Conditions
- Atopic DermatitisAtopic DisordersEczemaAtopic Eczema
- Registration Number
- NCT03409367
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
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.
Our central hypothesis is 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.
- Detailed Description
AD affects over 9 million children in the U.S. and ranks first among all skin conditions in global disability burden. AD often heralds the development of several comorbidities including asthma, food allergy, skin infections and neurodevelopmental disorders. Because of the significant socioeconomic impact of atopic dermatitis and its effect on the quality of life of children and families, there have been decades of research focused on prevention with limited success. Recent advances in cutaneous biology identify epidermal defects and skin barrier dysfunction to be the key initiators of atopic dermatitis and possibly allergic sensitization. Our central hypothesis is that emollient therapy from birth can prevent the development of AD. The findings of this trial will support the development of evidence-based skin care clinical guidelines for infants that currently do not exist. Recently, our international multi-centered clinical trial found enhancing early skin barrier function with daily emollient use from birth significantly reduces the risk of AD development in high-risk populations by 50%. With CASCADE, we extend this work into the community setting and into newborns unselected for risk, so results will be immediately applicable to the population at large and will establish a new standard of care for all newborns.
The specific aims are as follows:
1. Perform a community-based pragmatic randomized controlled trial investigating whether daily full-body emollient application starting in the first 2 months of life prevents atopic dermatitis in a real-world setting. The population for this trial consists of newborns between 0-2monthsof age, not selected for risk. Recruitment of families will occur during the course of routine care within primary care offices that are members of practice-based research networks(PBRNs).The intervention includes general skin care recommendations plus full-body daily lipid-rich emollient use. The control population will receive general skin care advice only and refrain from daily emollient use. The primary outcome will be the cumulative incidence of atopic dermatitis at age 24 months as determined by blinded clinicians trained in the diagnosis of AD. Key secondary clinical outcomes include time to disease onset and incidence of self-reported food allergy and wheeze using parental questionnaires.
2. As an exploratory aim, 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 atopic dermatitis. While the primary objective of this clinical trial is to determine the effectiveness of an emollient intervention in a real-world setting, data will be gathered on allergy history in the family and pet ownership-variables that may modify the effect of emollient therapy. Future implementation studies may target subpopulations found most likely to benefit from emollient intervention.
Twenty-five primary care clinics that participate in PBRNs from Oregon, Colorado, Wisconsin and North Carolina are the setting for the study protocol. The expected results from this project would represent a major public health breakthrough with the potential for reducing the atopic disease burden on a global scale.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1250
- 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 or phone that can receive text messages
- Parent has 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Cumulative incidence of provider-diagnosed AD up to 24 months The cumulative incidence of AD at 24 months of age as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record.
- Secondary Outcome Measures
Name Time Method Parental report of AD up to 24 months Parental report of provider-diagnosed AD
AD by Children's Eczema Questionnaire up to 24 months AD as diagnosed by the Children's Eczema Questionnaire (CEQ)
Asthma risk up to 24 months Asthma risk using a modification of the Asthma Predictive Index
Food allergy symptoms up to 24 months Parental report of immediate food allergy symptoms
AD by UK Working Party criteria up to 24 months Parental report of AD using UK Working Party criteria
Prescription or over-the-counter therapies for AD up to 24 months Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review
Sleep loss 12 and 24 months Parental report of sleep loss of the infant reported as average number of days per week (1 week recall) of disrupted sleep in their infant \[single item of IDQoL\]
Skin infections detected in chart review up to 24 months Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics
Prescribed topical skin medication up to 24 months Any steroidal or non-steroidal cream or ointment, recorded by parent or recorded from records review. Evaluated in (1) all children and (2) those with AD only.
Severity of AD symptoms using POEM up to 24 months In infants who develop AD, symptom severity as reported in the patient-oriented eczema measure (POEM) instrument
Provider-diagnosed asthma up to 24 months Asthma diagnosis from chart review
Reported diagnosis of food allergy up to 24 months Parental report of a provider diagnosis of food allergy that was confirmed by prick testing or IgE blood test
Severity of AD symptoms using IDQoL up to 24 months In infants who develop AD, symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQOL)
Trial Locations
- Locations (4)
University of Colorado-Denver
🇺🇸Denver, Colorado, United States
Duke University
🇺🇸Durham, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States