Feasibility Study of Barrier Enhancement for Eczema Prevention

Oregon Health and Science University46 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Eczema

Interventions

Sunflower oilDRUG

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Control groupDRUG

This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.

Aquaphor ointmentDRUG

One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 6 Months

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma 2. Infant in overall good health 3. Mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age 4. Capable of giving informed consent Exclusion Criteria: 1. Preterm birth defined as birth prior to 37 weeks gestation 2. Major congenital anomaly 3. Hydrops fetalis 4. Significant dermatitis at birth not including seborrheic dermatitis ("cradle cap") 5. Any immunodeficiency disorder or severe genetic skin disorder 6. Any other serious condition that would make the use of emollients inadvisable 7. Any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Proportion of families willing to be randomized.

Determine proportion of families willing to be randomized in order to design larger study in the future.

Time frame: 6 months

Secondary Outcomes

Proportion of families eligible for the trial, willing to participate

Time frame: 6 months

Proportion of families who found the interventions acceptable

Time frame: 6 months

Reported adherence with intervention

Time frame: 6 months

Proportion of families for whom the blinding of the assessor to the allocation ostatus was not compromised

Time frame: 6 months

Amount of contamination as a result of increased awareness in the control group

Time frame: 6 months

Percentage of missing data and early withdrawal rates

Time frame: 6 months

Incidence of emollient-related adverse events

Time frame: 6 months

Incidence of eczema at 6 and 12 months

Time frame: 12 months

Age at onset of eczema

Time frame: 6 months

Filaggrin mutation status

Time frame: 6 months

Data from ClinicalTrials.gov

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